Value Analysis Brief
Executive Summary
Unmet need:
Distal cortical impingement may occur in up to 25%
of hip fracture repair cases and is often the result of the curve of the natural
femoral anatomy being greater than the curve of the hip nail causing a
“mismatch”.1-3 This complication may lead to a fracture at the distal nail tip,
called anterior perforation, which requires revision surgery.1,4,5
Cut-out is a major cause of implant failure in the fixation
of proximal femur fracture, and may cause severe injuries in hard
and soft tissues surrounding the hip joint.6,7
Cut-out rates for cephalomedullary nails have been reported
as high as 8%, and frequently require reoperation.6
Nail breakage may occur in as many as 5% of hip
fracture patients treated with cephalomedullary nails and requires
revision surgery.9,10
Nail breakage is often a result of fractures that take longer to heal
or fail to heal (delayed union or nonunion, respectively).11
CLINICAL VALUE
1
The TFN-ADVANCED® Proximal Femoral Nailing System (TFNA) solution:
The TFNA System was designed with a 1.0 m radius of curvature
(ROC) to reduce the risk of distal cortical impingement and anterior perforation compared
to competitive nail systems with larger ROCs. A multi-ethnic, 3D computational study
showed the TFNA Nail (1.0 m ROC) resulted in a better fit than Gamma3 (1.5 m ROC).12
• The mean total surface area of the nail protrusion was 29% less for TFNA Nail
than Gamma3 (915.8 vs. 118.6mm,2 p< 0.05).12
• The distal nail tip was positioned close to the anterior cortex for 30 Gamma3
samples compared to 16 TFNA Nail samples (difference of 53%).12
TFNA Helical Blade technology was designed to compress bone during insertion, which enhances implant anchorage
and may reduce the risk of cut-out.19 Resistance to cut-out in osteoporotic bone is further improved by augmentation of the
Head Element.16,17 The decision to use augmentation to increase the stability in unstable fractures and osteoporotic bone58 is made
intra-operatively; thereby giving surgeons multiple options for treating their patients.58
• Biomechanical testing of off-center placement showed significant improvement in cut-out resistance for the
TFNA Helical Blade compared to both the TFNA Screw and Gamma3 Screw.12 These results showed the
TFNA Helical Blade was more forgiving compared to screws in regards to head element positioning.15
• Biomechanical tests designed to evaluate cut-out resistance showed, whether the head element
is in the center or off-center position, augmented head elements withstood high loads prior
to failure.14 Additionally, augmented constructs resisted varus collapse for more cycles than
non-augmented constructs.14
• A clinical study showed lower cut-out rates in the cohort treated with a helical blade (1.5%)
compared to a screw (2.9%).13 Early results from clinical studies of PFNA (a predicate of the
TFNA System) with augmentation showed cut-out rates of 0%.16,17
Cut-out rates in the chart below were reported in three published clinical studies: Stern et al.
2011 (n=335 patients), Kammerlander et al. 2011 (n=59 patients), and Kammerlander et al. 2014
(n=62 patients).13,16,17
Implant Screw Helical Blade PFNA Head Element with augmentation
Cut-out rate 2.9%13 1.5%13 0%16,17
TFNA SYSTEM WAS SHOWN TO BE
47% STRONGER
THAN INTERTAN18TFNA SYSTEM WAS SHOWN TO BE
24% STRONGER
THAN GAMMA318
Distal Nail Tip Position is less anterior with the TFNA Nail than the Gamma3 Nail
The TFNA System is made out of a unique titanium alloy
(TiMo alloy) that allows the proximal diameter of the nail to be reduced, while
maintaining a high level of fatigue strength. This material, combined with the
BUMP CUTTM Design of the proximal hole, provides improved fatigue strength
compared with existing nails of similar size.18 Results of biomechanical testing
showed greater fatigue strength for the TFNA System compared to Gamma3
and InterTAN nails (difference of 24% and 47%, respectively; p< 0.05).18
Benchtop test results may not be indicative of clinical performance.
4500
4000
3500
3000
2500
2000
1500
1000
500
0
Load
Fai
lure
(N)
Center position
+131%
Off-center position
+244%
Non-Augmented
Augmented
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 2
ECONOMIC VALUE
Economic Challenge: The TFNA System Solution:
High Cost of Reoperation
Reduction in reoperations
due to cut-out may reduce
costs to the hospital and
the healthcare system.
A sample budget impact
analysis was developed
to show the potential
economic impact to a
hospital. The analysis
evaluated the use of a
proximal nail system with
a screw compared to a
blade, and both head
elements compared to
augmentation using data
points from published
studies.13,16,17,71 Results
demonstrated that a
hospital with an annual
procedural volume of
200 cases per year may recognize savings of up to $270,147 when comparing augmented
to non-augmentated constructs through the reduction in reoperations due to cut-out.
Procedural Efficiency in the Operating Room
The instruments used with the TFNA System introduce design features, such as
QUICK CLICK® Self-Retaining Technology and radiolucent insertion handles with
radiographic indicators, designed to streamline the procedure in the OR, potentially reducing
OR time and minimizing pain points within the surgical procedure for OR staff and surgeons.
• 74% of surgeons (n=57 out of 77) “Strongly Agreed” or “Agreed” that “I felt the
new system improved the overall procedural efficiency compared to previously used
nailing systems”.20
• 77% of surgeons (n=59 out of 77) “Strongly Agreed” or “Agreed” that “The new
instrument is easier than what I used previously”.20
Hospital Standardization
Aligning surgeons with hospital cost reduction initiatives, such as standardization of
physician preference items, is an important step in reducing clinical supply spending and
creating opportunities for cost savings.
• 86% of early surgeon users (n=77) of the TFNA System stated they "Strongly Agreed"
or "Agreed" that they would "Recommend this new proximal femoral nailing system"20
• The flexibility of the TFNA System allows the surgeon to customize the procedure based
on patient need and surgeon preference.
For the hospital, the TFNA System offers a single hip nail system providing surgeons with the
choices they need to treat a wide variety of fracture types while promoting hospital
standardization strategies.
$300,000
$250,000
$200,000
$150,000
$100,000
$50,000
0Screw Helical Blade
Hea
lthca
re C
osts
(USD
/200
Pat
ient
s/Ye
ar)
$130,416 difference
$139,731 vs. Blade$270,147 vs. Screw
With Augmentation
Budget Impact Analysis – Annual Costs of
Reoperation May Be Less for Augmented
Constructs Compared to Non-Augmented Based
on Differences in Cut-Out13,16,17,71
Budget impact analysis assumptions: Cost of reoperation was $46,577;71 Reoperation rates due to cut-out were 2.9%13 for the screw, 1.5%13 for the blade, and 0%16,17 with augmentation; Procedure volume of 200 hip fracture cases per year.
3
BACKGROUND
Pertrochanteric, simple Pertrochanteric, multifragmentary
Intertrochanteric Subtrochanteric
Most hip fractures are treated by orthopedic surgery, which involves implanting an orthopedic device. The fracture
takes approximately 4-6 months to heal.34 The surgery is a major stress on the patient, particularly in the elderly.
Revision procedures should be avoided given the increased risk to these patients.
Hip fractures are common in the elderly, and the incidence is expected to rise as the population
ages.23 Costs of managing hip fractures in the elderly were nearly $20 billion in 2010.40
Reducing the reoperation rate, estimated at 6.3%,39 provides an opportunity for hospitals
to reduce costs.
HIP FRACTURESA hip fracture is a femoral fracture that occurs in the proximal end of the femur (thigh bone), near the hip.24 The
term “hip fracture” is commonly used to refer to the fracture patterns shown in Figure 1. In the vast majority of
cases, a hip fracture is a fragility fracture due to a fall or minor trauma in someone with weakened osteoporotic
bone.29 Hip fractures in people with normal bone are often the result of high-energy trauma such as car accidents,
falling from heights (> 10 ft.), or sports injuries.29
FIGURE 1: Types of hip fracture patterns25
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 4
EpidemiologyEach year, approximately 300,000 hip fractures occur in the United States (U.S.).30 Hip fracture rates increase
exponentially with age, with almost 90% of hip fractures occurring in people aged 65 years and older.75,76 As the
U.S. population ages, the incidence of hip fracture is expected to increase substantially. It is estimated that by 2040,
the annual incidence of hip fractures will exceed 500,000 in the U.S.77 These continuing trends will place a financial
burden on patients, families, insurers, and governments.23
• Intertrochanteric fractures constitute up to 55% of proximal femoral fractures and occur predominantly in elderly
patients.26 Most commonly, intertrochanteric fractures are caused by low-energy trauma events, such as falls from
a standing position, usually in combination with osteoporosis.40
• Due to the patients' advanced age and multiple comorbidities, fractures of the proximal femur are often life
threatening: in the first postoperative year, mortality rates may be as high as 30%.28
• In young patients, intertrochanteric fractures are typically associated with high-energy trauma events, such as
motor vehicle, bicycle, and skiing accidents.26
Economic BurdenThe economic burden of managing hip fractures in elderly individuals in the U.S. was estimated at $17-20 billion in
2010.40 A typical U.S. patient with a hip fracture spends $40,000 in the first year following hip fracture on direct
medical costs and almost $5,000 in subsequent years.40 In the U.S., hip fractures are responsible for approximately
3.5 million hospital days per year, which is more than tibial, vertebral, and pelvic fractures combined.38
Clinical BurdenHip fractures result in pain, loss of mobility, and high rates of mortality.31 Nearly all patients are hospitalized and
most undergo surgical repair of the fracture using cephalomedullary nails. Fractures of the hip are associated with
significant loss of function; one year after the fracture, fewer than 50% of patients have the same walking ability
they had prior to the hip fracture.32 Many patients lose their independence and need long-term care. Comorbidity
is an important contributory factor to hip fractures and is often a determinant of outcome.31
The reoperation rate of cephallomedullary hip nailing has been estimated at approximately 6.3%.39 The most
common complications resulting in revision include distal cortex penetration (≤ 3% revision rate),43 proximal
cut-out or lateral extrusion (≤ 8% revision rate),6 implant breakage (≤ 5% revision rate)9 or severe thigh pain.
Reoperations increase the risk to the patient and are costly to the health care system. Revision surgery is associated
with a poor prognosis, an increase in mortality, a decrease in the number of patients able to return to their original
residence, and a 2.5-times increase in the cost of treatment.37
5
METHODS
This value analysis brief presents information on the potential clinical and economic benefits of using the TFNA
System. The referenced data were obtained through a literature review of Ovid Medline, Ovid Embase, and PubMed
for clinical and economic studies published from 2003-2017.
This literature search resulted in a total of 97 publications that met the inclusion and exclusion criteria. Papers were
selected for use in this value analysis brief based on the highest level of clinical, biomechanical, and economic
evidence. Recently completed biomechanical studies were also included to support the value propositions for the
TFNA System and are referenced as “Data on File”.
Published results included studies reporting outcomes for proximal hip nails with similar features as the TFNA
System. The TFNA System builds upon the clinical heritage of existing DePuy Synthes Trauma technology:
• The TFNA Helical Blade technology is similar to the existing helical blade technology used in the Trochanteric
Fixation Nail (TFN) and Proximal Femoral Nail Antirotation (PFNA) Systems.*
• The LATERAL RELIEF CUT™ is comparable to the lateral relief cut of the Proximal Femoral Nail Antirotation-II
(PFNA-II) System.*
• The augmentation option available with the TFNA System is analogous to the cement augmentation option
available with the PFNA System.
* PFNA and PFNA II do not have 510(k) clearance and are not available for sale in the US.
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 6
TFNA SYSTEM CLINICAL VALUE
Penetration of the anterior cortex of the distal femur is a complication associated with treating proximal femoral
fractures with intramedullary devices.1 Use of long cephalomedullary nails may result in the distal tip of the nail
abutting the anterior cortex of the femur, which is called "nail impingement".1 Distal cortical impingement is
often the result of the curve of the femoral anatomy being greater than the curve of the hip nail (nail-canal
mismatch, see Figure 2).1-3 Published clinical studies have reported rates of distal cortical impingement of up to
49.6%,43 and this complication may lead to a fracture at the distal nail tip in the early post-operative period.1
This fracture event, called anterior cortex perforation, occurs in up to 3% of cases and requires revision surgery.4,5
Cephalomedullary nail designs include both short and long nails. The long nails extend to the end of the distal
femoral metaphysis (i.e. wide portion of the bone above the femoral condyles).44 The distal nail design,
specifically the radius of curvature (ROC) of a long nail, as well as the nail entry point and proximal nail
geometry are important factors for clinical success.3
Prior to the launch of the TFNA System, the ROCs for commercially available cephalomedullary nails ranged from
1.3 m to 3.0 m,45-47 and clinical experiences from recent studies have shown that these ROCs may lead to
complications resulting from nail-canal mismatch.3,47,48 Collinge and Beltran (2013) reported that femoral nails
with a ROC of 1.5 m more closely approximate the femoral bow of geriatric patients with hip fracture than nails
with a ROC of 2.0 m, and may be less likely to cause complications, such as anterior cortical abutment,
perforation, or fracture.3 This study reported rates of distal cortical impingement of 12% with a 2.0 m ROC nail
(InterTAN Nail System with 2.0m AP bow, Smith and Nephew) but only 3% with a 1.5 m ROC nail (InterTAN Nail
System with 1.5m AP bow, Smith and Nephew).3 A nail resting against the anterior femur also may be
associated with thigh or knee pain. Therefore, continuing to decrease the nail ROC to more closely match
anatomical measurements may further improve treatment outcomes.
DISTAL CORTICAL IMPINGEMENT AND ANTERIOR CORTEX PERFORATION
The TFNA System was designed to enhance anatomic fit, which may improve patient outcomes
and reduce the risk of postoperative complications.
ROC = Radius Of Curvature
Note: The gold nail represents the TFNA Nail with 1.0 m ROC. The blue nail represents a nail with 1.5 m ROC.
FIGURE 2: Curvature of the TFNA Hip Nail System (1.0 m ROC)
and nail with 1.5 m ROC
7
FIGURE 3: Distal Nail Tip Position for TFNA System Compared to Gamma312
35
30
25
20
15
10
5
0
TFNA System Gamma3
Num
ber
of b
ones
Anterior
20
13
Center
13
7
Posterior
2 1
Far posterior
1 0
Far anterior
16
30
The TFNA Nail was designed with a ROC of 1.0 m to more closely match the femoral anatomy compared to hip
nails with larger ROCs (i.e straighter nails). The TFNA Nail was evaluated in a 3D computer modeling study that
quantified whether the 1.0 m ROC provides a better anatomical fit compared with existing nail with a bow
design (Gamma3 Long Nail R1.5, Stryker Trauma).12 This study included samples derived from Caucasian (n=31),
Japanese (n=28), and Thai (n=4) subjects with a mean age of 77 years (range 65 to 103 years). The 3D computer
modeling showed:
• TFNA Nail had a significantly smaller mean total surface area of nail protrusion than the Gamma3 nail
(915.8 vs. 1181.6 mm2; p< 0.05).12
• Mean maximum distance of nail protrusion in the axial plane was significantly less for the TFNA Nail than the
Gamma3 nail (1.9 vs. 2.1 mm; p= 0.007).12
• Mean total surface area of nail protrusion was significantly smaller with the TFNA Nail compared to Gamma3
in Caucasian (p=0.0009) and Asian samples (p= 0.000002).12
The distal nail tip position was also evaluated. The distal nail tip was positioned close to the anterior cortex
for 30 Gamma3 samples compared to 16 TFNA Nail samples, a difference of 53% (Figure 3).12 Additionally,
the TFNA Nail had a considerably higher number of center positions than the Gamma3 nail (n=13 vs. 7).12
Far anteriorAnteriorCentrePosteriorFar posterior
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 8
FIGURE 4: Distal Nail Tip Position of the TFNA
Nail is Positioned Less Anteriorly than the Gamma3
Nail in a Caucasian Model with ROC 1.015 mm12
The study also showed that an average Caucasian sample with a ROC of 1.015 m resulted in a slightly smaller
mismatch in the sub-trochanteric region for the TFNA Nail compared with the Gamma3 Nail (Figure 4). Distally, the
TFNA Nail achieved a center position while the Gamma3 nail showed an anterior position.12 The results of this
study showed the TFNA Nail, with a 1.0 ROC design, resulted in a better fit compared with the Gamma3 nail with
a 1.5m ROC design. This could result in clinical improvements in implant fit and potentially fewer post-operative
complications.12
In addition to nail-canal mismatch and anterior perforation of the cortex, lateral extrusion of the nail and
impingement are also potential complications associated with nail fit. The small proximal diameter and the
LATERAL RELIEF CUT Design of the TFNA Nail (Figure 5) were designed to avoid impingement on the lateral cortex
while preserving bone in the insertion area, potentially reducing the risk of fracture displacement. Additionally,
the oblique cut on the lateral end of the TFNA Helical Blade and Screw was designed to reduce lateral protrusion
on the soft tissues when compared with that of a standard cut head element.49
FIGURE 5: TFNA System: Designed with
a Small Proximal Diameter, Oblique cut,
and LATERAL RELIEF CUT Design
TFNA System
Gamma3 Oblique cut on the lateral end of head element
Small proximal diameter
LATERAL RELIEF CUT™
Design
◀15.66 ▶ mm
◀14.12▶ mm
9
FIGURE 7: TFNA Screw and
TFNA Helical Blade
TFNA Helical Blade
TFNA Screw
TFNA Helical Blade technology is designed to compress bone during insertion, which enhances implant
anchorage and may reduce the risk of cut-out, a serious post-operative complication often resulting in
reoperation. The use of augmentation is an option for providing additional cut-out resistance, when needed,
in patients with poor bone quality. Cut-out is a major cause of implant failure in dynamic hip screws,
accounting for more than 80% of failures.60,78
PROXIMAL CUT-OUT
Definition of Cut-OutImplant cut-out is a loss of implant anchorage in the bone that causes the femoral neck-shaft
angle to collapse, leading to extrusion, or cutting-out, of the screw or blade element from
the femoral head (Figure 6). Revision surgery is frequently necessary when cut-out occurs.16
Cut-out is the major cause of implant failure in the fixation of proximal femur fractures,
accounting for more than 80% of failures in cases using dynamic hip screws.60,78 Cut-out
rates for cephalomedullary nail devices were reported at 3.2% in a Cochrane review of the
literature,39 and have also been reported as high as 8%.6 Cut-out continues to be a major
complication for intramedullary hip nailing devices13 and may cause severe injuries in hard
tissues as well as in soft tissues surrounding the hip joint.7 The TFNA System has
incorporated two features that were designed to reduce the risk of cut-out: the helical
blade and augmentation.
Advantages of Helical BladesHelical blade devices offer an advantage in fracture repair because they allow for bone
compaction around the head element and avoid the bone loss that occurs with the drilling
and insertion of the standard hip screw. Figure 7 shows the TFNA Helical Blade and Screw.
The helical blade is designed to be implanted without pre-drilling, which displaces the
bone in the voids of the surrounding cancellous bone material (Figure 8). The bone
compression that results from inserting a helical blade50 increases trabecular bone density
in the surrounding area.60 This enhances implant anchorage and provides additional
purchase (i.e., a firm grip) in osteoporotic bones, which may result in a decreased risk of
cut-out.50 Additionally, this increase in bone compaction may minimize the potential for
rotation of the blade.
Helical blades have shown a higher potential for rotational stability compared with
screw-based nails.7 Furthermore, the helical blade is associated with a statistically
significant 2- to 4-fold higher torque resistance reducing rotational forces during
insertion compared with a screw system.7 Anti-rotation
wires are often required with screws to
counterbalance these forces.51 Use of the blade
lessens the need for anti-rotation wires, which
may add to the procedural efficiency of the
surgical technique.
FIGURE 6: Example of Cut-Out
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 10
The resistance to cut-out of the TFNA Helical Blade was compared to the TFNA Screw and
the Gamma3 Screw in a biomechanical study using a foam model with properties that
mimic osteoporotic bone.19 Head elements were tested for fatigue strength in the foam
model based on the position of the head element (either center or anterior off-center).19
These measurements showed the range of placement options that may occur during a hip
nailing procedure. Center position is the optimal placement of the head element;53
however, actual placement may vary from surgeon to surgeon resulting in off-center
positioning of the head element.19 The mean failure load was calculated for each study
group (TFNA Helical Blade, TFNA Screw, and Gamma3) to determine the resistance to
cut-out.19 Results showed failure loads in a similar range for all head elements included in
the analysis for the center position (range of 1489N to 1613N).19 For the off-center study
group, the TFNA Helical Blade is more forgiving than the TFNA Screw and Gamma3 Screw
in terms of positioning and also shows greater resistance to cut-out.19
In addition to the study evaluating the TFNA System,19 several biomechanical studies have
also been published showing the improved cut-out resistance of helical blades compared
to lag screws.52,53,60 The improved cut-out resistance of helical blades compared to lag
screws has also been studied clinically. The following clinical studies report the cut-out rates
of helical blades compared to screws:
• A prospective, randomized clinical trial of 335 pertrochanteric and intertrochanteric
fractures reported lower cut-out rates in the blade group (1.5%) compared with the
screw group (2.9%). All cases of cut-out resulted in reoperation.13
• A multicenter, case-series of 315 fractures concluded that nails with a helical blade limit
the effects of early rotation of the head/neck fragment in unstable trochanteric fractures;
likely preventing rotation-induced cut-out.54
• In a single-center, case-series study of 322 patients with
proximal femur fractures, cut-out rates were lower with
third-generation nails with helical blades (cut-out rate 2.5%-
7.0%) than with second-generation nails with lag screws
(14% cut-out rate).55
Mingo-Robinet and colleagues (2015) evaluated the relationship
between the type of intramedullary device and the presence of
cut-out complications.56 The Trochanteric Gamma Nail (Stryker)
and Gamma3 Nail (Stryker), both using lag screws, were
included in the analysis of 218 fractures. Results show cut-out
rates of up to 3.9% in patients with undisplaced fractures
treated with Gamma Nail and up to 33.3% in patients treated
with Gamma3.56 The authors noted that unstable fracture was
one of the most important risk factors for fixation failure.56
The TFNA Helical Blade Technology provides the enhanced
stability that is critical for reducing the risk of cut-out compared
to a lag screw.
FIGURE 8: TFNA Helical Blade
technology: Designed to
Compress Bone During Insertion
Note: Cross-sections of bone illustrating TFNA Helical Blade (left) and TFNA Screw (right)
TFNA Screw
TFNA Helical Blade
FIGURE 9: Cut-Out Resistance in vitro Modeling
Load
at
failu
re in
N
TFNA Helical Blade Shows Greater Resistance in the Off-Center Position Compared to TFNA Screw and Gamma3 Screw19
Gamma3 ScrewTFNA ScrewTFNA Helical Blade
1600
1200
800
400
0
11
Advantages of AugmentationFailure of fixation and cut-out are common problems in the treatment of osteoporotic hip fractures.57,58 Low
bone mineral density and thin cortices not only are major risk factors for hip fractures but also contribute to
the failure of fixation postfracture.57 Achieving stable fixation contributes to early patient mobilization and
good fracture healing.58
Augmentation of poor quality bone with polymethylmethacrylate (PMMA) or calcium phosphate bone cement
may increase the stability of nail osteosynthesis, especially in osteoporotic bone.17 Augmentation involves
injecting the cement into the femoral head; the process takes approximately 10 to 15 minutes.16 The decision
to augment may be made during surgery, allowing for full intra-operative flexibility for the surgeon.
TFNA Helical Blades and Screws may be augmented with TRAUMACEM™ V+ Injectable Bone Cement. This
cement is inserted through the head element with a syringe and a specific needle kit compatible with the
TFNA Helical Blades and Screws (Figure 10).61 The cannulation of the implant, and additional fenestrations in
the TFNA Helical Blades and Screws, enable the controlled injection of cement into the surrounding bone
tissue after implant insertion.
The TFNA System offers cement augmentation of the head element. Augmentation provides
fixation stability and resistance to cut-out, cut through and unexpected blade migration, especially
in osteoporotic bone.16 The decision to augment may be made during surgery, providing surgeons
with flexible intra-operative solutions for their patients.
Source: DePuy Synthes Trauma.
FIGURE 10: TFNA Helical Blade with Augmentation
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 12
Biomechanical StudiesBiomechanical studies have been conducted to evaluate the performance of the TFNA System with augmentation.
The failure load (which is the maximum amount of force that can be applied to the nail construct in a
biomechanical simulation, after which the cut-out event occurs) of the TFNA Head Element was evaluated for
constructs with and without augmentation. The study included samples with the head elements in the center
position as well as the off-center position.14 While center position is the optimal placement of the head element,14
placement may vary from surgeon to surgeon resulting in off-center positioning.53 This study used an artificial bone
material that mimics human osteoporotic bone in the femoral head.14 Results demonstrated a significant
(p= 0.000) increase in failure load (simulated decrease in cut-out) when the TFNA Head Element is augmented.
The increased failure load exceeded 131% compared with non-augmented constructs in the center position. The
greatest improvement in failure load (simulated cut-out event) was observed for the TFNA Construct in the
off-center position, which improved by 244%.14 Furthermore, augmented constructs resisted varus collapse for
more cycles than non-augmented constructs both in the center (+271%) and off-center (+346%) positions.14 This
study demonstrated that augmentation of the TFNA Helical Blade and Screw allowed the constructs to withstand
higher loads for more cycles, which may correlate with increased cut-out resistance in osteoporotic bone.
4500
4000
3500
3000
2500
2000
1500
1000
500
0
Non-Augmented Augmented
Load
Fai
lure
(N)
Off-center positionCenter position
+131%
+244%
FIGURE 11A: Augmented Head Elements Withstood Higher Loads
Prior to Failure14
3500
3000
2500
2000
1500
1000
500
0
Non-Augmented Augmented
Cyc
les
to 5
° Va
rus
Col
laps
e
Off-center positionCenter position
+271%
+346%
FIGURE 11B: Augmented Constructs Resisted Varus Collapse for More
Cycles Than Non-Augmented Constructs14
Benchtop test results may not be indicative of clinical performance.
13
Clinical Studies Kammerlander and colleagues (2011) reported the results of a prospective, multi-center study to evaluate the
technical performance and early clinical results of augmentation of the PFNA blade with PMMA bone cement
(mean volume 4.2 mL).16 A total of 59 patients with osteoporosis were included in the study (mean age 84.5
years); mean follow-up was 4 months. Results showed 55.3% of the patients reached the same or better mobility
than before the fracture. No events of cut-out, cut-through, unexpected blade migration, implant loosening, or
implant breakage were observed. The overall surgical complication rate was 3.4%; however, no complications
were related to the cement augmentation. These early clinical results show augmentation of the PFNA blade
resulted in no cut-out, cut through, unexpected blade migration, implant loosening or implant breakage, and led
to good functional results within the study period.16
Kammerlander and colleagues (2014) reported long-term results (mean follow-up 15.3 months) from an enlarged
population of the same patient group from the study published in 2011.16,17 In the 62 patients included in the
analysis, 59.6% of patients reached their pre-fracture mobility level within the follow-up time frame. The overall
surgical complication rate was 3.2%, with no complications related to the cement augmentation. The mean hip
joint space did not change significantly at follow-up, and there were no signs of osteonecrosis in the follow-up
x-rays. In addition, no unexpected blade migration was observed. Augmentation with the PFNA blade led to good
functional results and was not associated with cartilage or bone necrosis.17 Table 1 presents a side by side
comparison of the results from the two analyses of this patient group.
TABLE 1: Side-by-Side Comparison of Short-Term and Long-Term Results
of Cement Augmentation of the PFNA16,17
Clinical Outcome Kammerlander et al., 2011 (N = 59) Kammerlander et al., 2014 (N = 62)
Mean follow-up 4 months 15.3 months
Mean volume of cement injected 4.2 mL 3.8 mL
Percentage of patients reaching their pre-fracture mobility level
55.3% 59.6%
Overall surgical complication rate 3.4% 3.2%
Complications related to cement augmentation
None None
Cut-out rate 0% 0%
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 14
IMPLANT STRENGTHDelayed unions or nonunions are defined as broken bones that take longer than usual to heal or fail to heal,
respectively.11 Instances of delayed unions or nonunions create excess stress on the nail.62 Excess stress can cause
nail failure, which frequently occurs at the proximal hole of the nail. Nail breakage may occur in as many as 5%
of hip fracture patients treated with cephalomedullary nails.9 Nail breakage requires revision surgery to replace
the broken nail with a total hip arthroplasty, a hemiarthroplasty, or another hip nail.10
Resistance to Nail Breakage: Nail StrengthThe TFNA Nail was designed with specific features and materials allowing it to have a reduced proximal diameter
without compromising strength.
The TFNA System is constructed of T-15Mo (TiMo) titanium alloy. Gamma3 (Stryker) and InterTAN (Smith and
Nephew) are both made of Ti-6Al-4v (TAV) ELI alloy while other commercially available hip nails are made of
Ti-6Al-7Nb (TAN). TiMo was chosen as the alloy for the TFNA System because of its combination of high
strength and fatigue resistance. TiMo is a biocompatible titanium alloy that meets the requirements of ASTM F
2066 testing protocol. When heat-treated, the minimum mechanical strength of Ti15Mo is 33% higher than
TAV and 28% higher than TAN (see Figure 12).63,64 Additional testing showed that Ti-15Mo is not only stronger,
but it is also as flexible as TAV and TAN.65,66
The increased strength in combination with the BUMP CUT™ Design of the proximal hole (Figure 13), and other
design improvements in the TFNA System provides improved fatigue strength in benchtop testing when
compared with existing nails of similar size.18
The TFNA Nail offers improved fit without compromising nail strength.
FIGURE 13: TFNA System BUMP CUT Design FIGURE 12: TFNA System Material Strength
1400
1200
1000
800
600
400
200
0
Mpa
TiMo is Stronger than TAV and TAN
TANTAVTIMo
Benchtop test results may not be indicative of clinical performance.
15
FIGURE 14: Fatigue Limit Was Greater for TFNA
Nails than Gamma3 and InterTAN Nails18
1900
1800
1700
1600
1500
1400
1300
1200
1100
1000
TFNA System Gamma3 InterTAN
24% difference* 47% difference*
Proximal diameters of the nails
FIGURE 15: TFNA Nail Showed
Greater Fatigue Strength than
the Gamma3 Nail67
1750
1500
1250
1000
750
500
TFNA System Gamma3
Benchtop test results may not be indicative of clinical performance.
Physical fatigue load testing was conducted to compare the strength of the TFNA System to Gamma3 (Stryker) and
InterTAN (Smith and Nephew).18 The median fatigue limit for the TFNA Nails was 24% greater than the Gamma3
nail (p< 0.05) and 47% greater than the InterTAN nail (p< 0.05) (Figure 14), differences that were statistically
significant.18 These results showed the increased strength of the TFNA Nail compared to other nail systems with
similar proximal diameters (Figure 14).
An increase in fatigue strength of the TFNA System compared to Gamma3 was also observed using finite element
analysis (FEA).67 These results are shown in Figure 15.
Med
ian
Fatig
ue L
imit
(N)
Med
ian
Fatig
ue L
imit
(N)
* Differences compared to the TFNA System were statistically significant (p< 0.05)
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 16
Static LockingMost cephalomedullary nail systems provide surgeons the ability to rotationally lock the head element in position
allowing for translation of the head element but not rotation, which is commonly referred to as guided collapse.
The TFNA System provides surgeons with the option to statically lock the head element thus preventing both
rotation and translation. Static locking involves fully tightening the set screw onto the head element so that linear
movement of the head element is prevented by friction.68 Post-operative complications, such as excessive fracture
collapse from head element sliding and prominent hardware pain, may be prevented with static locking.69
The mean slippage load of the statically locked TFNA System was compared to statically locked Gamma3 and
InterTAN constructs.70 The TFNA System showed a 48% improvement in slip load compared to Gamma3
(p< 0.001) and 47% improvement in slip load compared to InterTAN (p< 0.001).70 These results are shown in
Figure 16. The TFNA System was the only implant system to complete the dynamic portion of the testing
without slippage of the head element.69
FIGURE 16: Static Locking: Mean Slippage Load of the TFNA System
Was Greater than Gamma3 and InterTAN70
TFNA System Gamma3 InterTAN
48% difference* 47% difference*
1000
900
800
700
600
500
400
300
200
100
0
Med
ian
Fatig
ue L
imit
(N)
* Differences compared to the TFNA System were statistically significant (p< 0.001)
Benchtop test results may not be indicative of clinical performance.
17
HIP FRACTURES: HOSPITAL INPATIENT STATISTICS Table 2 shows 2014 Centers for Medicare and Medicaid Services national statistics for Medicare Severity
Diagnosis-Related Groups (MS-DRGs) related to treating hip fractures with cephalomedullary nails.8
Both primary hip nailing procedures and revisions fall under MS-DRGs 480, 481, or 482, depending on
severity of complications and comorbidities.
TABLE 2: National Statistics from the Centers for Medicare and Medicaid Services (CMS)8
cc= complications and comorbidities; mcc = major complications and comorbidities; w/ = with; w/o = without
Note: DRGs 480/481/482 include treatment of hip fractures with intramedullary devices and plates. Total hip arthroplasty and hemi-arthroplasty procedures are covered under separate DRG categories. Hospital costs and charges for inpatient procedures are publicly available from CMS as reported in the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS).
TFNA SYSTEM ECONOMIC VALUE
The TFNA System includes Helical Blade Technology and the option for cement augmentation;
and both features may reduce the risk of cut-out.16,17 Reduction in cut-out and subsequent reduction
in reoperations may result in substantial economic savings to the hospital system.
Total Number of Discharges per DRG
% of Patients on Medicare
Length of Stay (Mean)
Hospital Charges (Mean)
Hospital Costs (Mean)
MS-DRG 2014
480 Hip & femur procedures except major joint w/ mcc
44,805 78.4% 8.1 $88,715 $23,324
481 Hip & femur procedures except major joint w/ cc
139,140 77.8% 5.1 $59,481 $15,877
482 Hip & femur procedures except major joint w/o cc/mcc
66,785 52.5% 3.7 $48,924 $13,191
Weighted Average 5.3 $61,893 $16,492
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 18
Hip Fractures: 90-day Costs of Reoperation The TFNA System was designed to reduce costly reoperations resulting from cut-out. To understand the full
economic impact of a reoperation, the healthcare costs of hip fracture reoperations were evaluated for both the
acute-care setting as well as during the 90-day post-operative period, as many post-operative services are part of
the hospital network. A retrospective claims database analysis was published by Lerner and colleagues (2016) to
determine the cost of reoperation associated with cephalomedullary fixation in patients aged 65+.71 Direct medical
resource utilization (claims payments) across multiple settings of care were explored for the 90-day period after
index hospitalization.71 Costs of hospitalization as a result of reoperation were reported as being $14,785 (referred
to as “Index Hospitalization” in Table 3) and total cost of reoperation, inclusive of the 90-day post-operative
period, were demonstrated to be $46,577 (Table 3). Table 3 also reports days of service for each post-acute care
setting. The average hospital length of stay for these patients was 5.3 days. The highest cost for post-acute care
service was time spent in a skilled nursing facility. Patients stayed in this setting of care for an average of 37 days
for a cost of $12,002. Costs associated with the physician, inpatient rehabilitation, home health care, and
additional inpatient readmissions were also substantial.
TABLE 3: Total 90-Day Costs of Reoperation Associated with Cephalomedullary Fixation
in Patients Aged 65+
Mean Cost of Reoperation
Days of Service Payment Amounts (USD)
Setting of Care Mean SD Mean SD
Index hospitalization 5.3 2.8 $14,785 $4,542
Physician -- -- $5,159 $3,925
Durable Medical Equipment -- -- $203 $536
Home Health Agency 15.6 25.0 $2,936 $3,802
Skilled Nursing Facility 37.0 28.7 $12,002 $11,656
Inpatient Rehab Facility 2.2 7.2 $4,206 $11,904
Other inpatient admissions 3.1 5.8 $6,960 $15,127
Hospice 3.5 15.6 $326 $1,365
Total -- -- $46,577 $26,607
USD = US Dollars; SD= Standard Deviation
The cost of reoperation shown in Table 3 is the average cost per episode. For a hospital treating multiple hip
fracture patients per year, the economic impact of treating reoperations may become quite significant.
Technologies designed to reduce costly reoperations, such as the TFNA System, should be considered in support
of Institute for Healthcare Improvement (IHI) Triple Aim strategies.
19
ECONOMIC VALUE OF THE TFNA SYSTEM Reduction in reoperations due to cut-out or other complications may reduce the overall economic burden of
treating hip fractures and are direct ways to reduce costs to the hospital as well as to the health care system.
Complications following hip fracture, such as infection, implant removal, fracture, and fixation failure are costly.37
Quantification of the economic impact of complications and revisions may be assessed using a sample budget
impact analysis with input parameters based on published data sources and annual volume assumptions. The
sample analysis below shows the potential economic impact to a hospital using a proximal hip nailing system with
a helical blade compared to a screw. The following input parameters were used and included cut-out rates
reported in three published clinical studies: Stern et al. 2011 (evaluating screw vs. blade; 335 patients),
Kammerlander et al. 2011 (evaluating PFNA with augmentation; 59 patients), and Kammerlander et al. 2014
(evaluating PFNA with augmentation; 62 patients):
Lag Screw Helical Blade Augmented Construct
Reoperation Rates Due to Cut-Out 2.9%13 1.5%13 0%16,17
Mean 90-Day Direct Costs of Reoperation71 $46,577 $46,577 $46,577
Annual Hospital Volume* 200 200 200
*Hospital volume assumption is representative of a mid-volume hospital.
Note: Sample Calculation = volume x cost of reoperation x reoperation rate due to cut-out:
TFNA Screw: 200 cases x $46,577 x 2.9% = $270,146.60
TFNA Helical Blade: 200 x $46,577 x 1.5% = $139,731
FIGURE 17: Annual Hospital Costs of Reoperation
May Be Less for Augmented Constructs Compared to
Non-Augmented Based on Differences in Cut-Out Rate
$300,000
$250,000
$200,000
$150,000
$100,000
$50,000
0
Lag Screw Helical Blade
Hea
lthca
re C
osts
(USD
/200
Pat
ient
s/Ye
ar)
$130,416 difference
$139,731 vs. Blade$270,147 vs. Screw
With Augmentation
Under these assumptions, the potential annual economic
impact of reoperations due to cut-out is shown in Figure 17:
• $270,147 for a hospital using the TFNA System with
augmentation compared to using the TFNA Screw
without augmentation.
• $139,731 for a hospital using the TFNA System with
augmentation compared to using the TFNA Helical Blade
without augmentation.
• $130,416 for a hospital using the TFNA Helical Blade
compared to the TFNA Screw, both without augmentation.
This economic analysis focused only on one postoperative
complication, cut-out. The economic impact to the hospital
may be even greater when the reductions in other
postoperative complication rates are factored into the analysis.
Reducing the risk of complications and rehospitalizations may
result in opportunities for cost savings and reductions in the
overall economic burden on the healthcare system.
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 20
FACILITATING OPERATING ROOM EFFICIENCY AND HOSPITAL STANDARDIZATIONIn addition to reduction in reoperation, further opportunities for cost offsets with the TFNA
System include the standardization of surgeon preference items and improved operating
room efficiency.
Procedural Efficiency in the Operating Room
Orthopedic instruments should be intuitive to use to allow the surgeon and operating
room (OR) team to focus completely on the patient and the procedure. The instruments
used with the TFNA System introduce design features, such as QUICK CLICK Self-Retaining
Technology and radiolucent insertion handles with radiographic indicators that were
designed to streamline the procedure in the OR, potentially reducing OR time and
minimizing pain points within the surgical procedure for OR staff and surgeons.
QUICK CLICK Self-Retaining Technology (Figure 18) is designed to ensure a fast and
effective link between the insertion handle and intramedullary nail, potentially improving
surgical efficiency and reducing OR time. A mishandled instrument or implant may result
in the need for immediate-use steam sterilization or traditional steam sterilization,
respectively. Unexpected sterilization may delay the surgical procedure as much as 30
minutes.72,73 Re-sterilizations and longer surgical times lead to a greater risk of infection and
blood loss for the patient.41,42,72,74 For hospitals, longer procedure times and re-sterilizations
result in increased costs in addition to the risk of infection and readmissions.
Radiolucent insertion handles with radiographic indicators allow x-ray visualization and
assist with guide wire placement (Figure 19). Placement of the guide wire in the femoral
head is a critical step in a hip-nailing procedure. Guide wire position dictates final
placement of the femoral head element. Studies have shown that proper positioning is
correlated with clinical success of the implant.13
The TFNA System is designed for procedural efficiency, optimized for hospital standardization,
and offers a wide array of options to address surgeon preference for treating a full range
of fracture types.
FIGURE 18: TFNA System
QUICK CLICK Technology
Instrumentation
FIGURE 19: TFNA System Radiolucent Insertion Handle
21
Facilitating StandardizationThe standardization of physician preference items is one way to enhance a hospital’s supply chain and drive
profitability.36 Two recent case studies examining the standardization of orthopedic physician preference items
show an 8% savings in a single Florida hospital ($400,000) and 32% savings in a Midwest 3-hospital system
($1.9M).27,35 In addition to cost reduction, standardizing implants may improve efficiency and quality of care.33
Aligning surgeons with hospital cost reduction initiatives, such as standardization of physician preference items,
is an important step in reducing clinical supply spending and creating opportunities for substantial savings.21
However, surgeons often develop a strong preference for a specific device or manufacturer, creating a challenge
for the hospital to incentivize alignment with standardization strategies that require surgeons to change devices.22
In a survey of 77 early users of the TFNA System, the surgeons were asked three questions related to their clinical
experience with the product:20
• 86% of surgeons stated they “Strongly Agreed” or “Agreed” that they “would recommend this new proximal
femoral nailing system”.
• 74% of surgeons “Strongly Agreed” or “Agreed” that “I felt the new system improved overall procedural
efficiency compared to previously used nailing systems.”.
• 77% of surgeons “Strongly Agreed” or “Agreed” that “The new instrumentation is easier than what
I used previously.”.
These results indicate a high level of surgeon satisfaction with the TFNA System. The strong willingness to
recommend the TFNA System is a good indicator of potential surgeon alignment in support of hospital
standardization strategies.
Flexibility of the TFNA SystemThe TFNA System offers the surgeon a wide portfolio of intramedullary nailing options for the proximal femur.
The flexibility of the TFNA System allows the surgeon to customize the procedure based on patient need and
surgeon preference. For the hospital, the TFNA System offers a single hip nail system providing surgeons with the
choices they need to treat a wide variety of fracture types while promoting hospital standardization strategies.
SUMMARYThe TFNA System was designed to solve a wide range of unmet needs for surgeons, OR staff, hospital
administrators, and patients. This system offers advancement in hip fracture treatment, including outcome-
based design, reduced procedural complexity, and comprehensive surgical options. The TFNA System was
developed to deliver clinical and economic value to patients, surgeons, and hospitals through improved
outcomes and cost savings opportunities.
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 22
TFNA SYSTEM PRODUCT DESCRIPTION
To suit a wide variety of clinical needs and surgeon preferences,
the system includes an array of options, including both short and
long nails and the option for augmentation. Further, it is the only
system to offer both helical blade and screw options using one
nail and the intra-operative option of augmentation. In addition,
the long nail provides three distal locking options, including a
unique oblique distal hole offset 10º, designed to better target
bone condyles.
The TFNA System also offers a preassembled locking mechanism
in the nail with the ability to both rotationally and statically lock
the helical blade or screw. All nails in the TFNA System are made
from a high-strength titanium alloy (Ti-Mo Alloy), and the
instrumentation is designed for procedural efficiency and
improved x-ray visualization.
For a complete list of indications for use, warnings, and precautions, please see the package insert or surgical technique.
FIGURE 20: TFNA System Showing Both Blade
and Screw Options
The DePuy Synthes Trauma TFNA System is a cephalomedullary proximal femoral nailing system (Figure 20)
designed to match patient femoral anatomy, help improve patient outcomes, and address a wide variety
of patient needs. Specifically, the TFNA System includes:
• A radius of curvature of 1.0 m
• LATERAL RELIEF CUT Design
• BUMP CUT Design
• Helical Blade Technology
• Fenestrated head elements to allow for use with TRAUMACEM V+ Augmentation System
23
1. Roberts JW, Libet LA, Wolinsky PR. Who is in danger? Impingement
and penetration of the anterior cortex of the distal femur during
intramedullary nailing of proximal femur fractures: preoperatively
measurable risk factors. J Trauma Acute Care Surg. 2012;73(1):
249-254.
2. Egol KA, Chang EY, Cvitkovic J, Kummer FJ, Koval KJ. Mismatch of
current intramedullary nails with the anterior bow of the femur. Journal
of orthopaedic trauma. 2004;18(7):410-415
3. Collinge CA, Beltran CP. Does modern nail geometry affect positioning
in the distal femur of elderly patients with hip fractures? A comparison
of otherwise identical intramedullary nails with a 200 versus 150 cm
radius of curvature. Journal of orthopaedic trauma. 2013;27(6):
299-302.
4. Parker MJ, Bowers TR, Pryor GA. Sliding hip screw versus the Targon PF
nail in the treatment of trochanteric fractures of the hip: a randomised
trial of 600 fractures. The Journal of Bone and Joint Surgery. British
volume. 2012;94(3):391-397.
5. Miedel R, Ponzer S, Tornkvist H, Soderqvist A, Tidermark J. The standard
Gamma nail or the Medoff sliding plate for unstable trochanteric and
subtrochanteric fractures. A randomised, controlled trial. The Journal of
Bone and Joint Surgery. British volume. 2005;87(1):68-75.
6. Wu D, Ren G, Peng C, Zheng X, Mao F, Zhang Y. InterTan nail versus
Gamma3 nail for intramedullary nailing of unstable trochanteric
fractures. Diagn Pathol. 2014 Oct 1; 9:191.
7. Al-Munajjed AA, Hammer J, Mayr E, Nerlich M, Lenich A.
Biomechanical characterisation of osteosyntheses for proximal femur
fractures: helical blade versus screw. Studies in health technology and
informatics. 2008;133:1-10.
8. Agency for Healthcare Research and Quality. National and regional
estimates on hospital use for all patients from HCUP Nationwide
Inpatient Sample (NIS). 2014. http://www.ahrq.gov/research/index.html.
Accessed July 16, 2017.
9. Brammar TJ, Kendrew J, Khan RJ, Parker MJ. Reverse obliquity and
transverse fractures of the trochanteric region of the femur; a review of
101 cases. Injury. 2005;36(7):851-857.
10. D'Arrigo C, Perugia D, Carcangiu A, Monaco E, Speranza A, Ferretti A.
Hip arthroplasty for failed treatment of proximal femoral fractures.
International orthopaedics. 2010;34(7):939-942.
11. American Academy of Orthopaedic Surgeons. Nonunions. March 2014.
12. Schmutz P, Amarathunga J, Kmiec J, S, Schuetz M, Yarlagadda P, B S.
Quantification of Femoral Nail Fit Using 3D Computer Modeling: a
Comparison between 1 m and 1.5 m Bow Designs. Journal of
Orthopaedic Surgery and Research. 2016; 11:53.
13. Stern R, Lubbeke A, Suva D, Miozzari H, Hoffmeyer P. Prospective
randomised study comparing screw versus helical blade in the
treatment of low-energy trochanteric fractures. International
orthopaedics. 2011;35(12):1855-1861.
14. DePuy Synthes Test Data on File. Windchill 0000268245.
15. TFNA Clinical Evidence Generation Performance of TFNA Head Element
In: Scherrer S, ed2015.
16. Kammerlander C, Gebhard F, Meier C, Lenich A, et al. Standardised
cement augmentation of the PFNA using a perforated blade: a new
technique and preliminary clinical results. A prospective multicentre
trial. Injury. 2011; 42(12):1484-1490.
17. Kammerlander C, Doshi H, Gebhard F, Scola A, Meier C, Linhart W, et
al. Long-term results of the augmented PFNA: a prospective multicenter
trial. Arch Orthop Trauma Surg. 2014; 134(3):343-349.
18. Fatigue strength testing of cephalomedullary nails. 2015.
19. Hofmann L, Zderic I, Hagen J, Agarwal Y, Scherrer S, Weber A, Altmann
M, Windolf M, Gueorguiev B. Biomechanical effect of bone cement
augmentation on the fixation strength of TFNA blades and screws.
Presented at 22nd Congress of the European Society of Biomechanics.
10-13 July 106. Lyon, France.
20. Market Preference Evaluation. 2014.
21. Moran C. Four steps to engage physicians in clinical supply cost
reduction. The Advisory Board: At the Margins. 2015:1-6.
22. Lee J. Losing preferential treatment. 2013. http://www.
modernhealthcare.com/article/20130215/MAGAZINE/302169953.
Accessed 05 July 2017.
23. Gu Q, Koenig L, Mather RC, 3rd, Tongue J. Surgery for hip fracture
yields societal benefits that exceed the direct medical costs. Clinical
orthopaedics and related research. 2014;472(11):3536-3546.
24. American Academy of Orthopaedic Surgeons. Hip Fractures. 2009.
25. Palm H, Gebuhr P. Intramedullary nailing appears to be superior in
pertrochanteric hip fractures with a detached greater trochanter: 311
consecutive patients followed for 1 year. Acta Orthop. 2011; 82(2):166-
170.
26. Rüedi TP, Buckley RE, Moran CG. AO principles of fracture
management. Vol 2. 2 ed. Davos: AO Publishing; 2007.
27. The Advisory B. Unlocking market value despite deep loyalty across
multiple incumbent suppliers. 2013.
28. Kraus M, Krischak G, Wiedmann K, et al. [Clinical evaluation of PFNA(R)
and relationship between the tip-apex distance and mechanical failure].
Der Unfallchirurg. 2011;114(6):470-478.
29. Hahnhaussen J, Hak DJ, Weckbach S, et al. High-Energy Proximal
Femur Fractures in Geriatric Patients: A Retrospective Analysis of
Short-Term Complications and In-Hospital Mortality in 32 Consecutive
Patients. Geriatric Orthopaedic Surgery & Rehabilitation. 2011;2(5-
6):195-202. doi:10.1177/2151458511427702.
30. Agency for Healthcare Research and Quality. National and regional
estimates on hospital use for all patients from the HCUP Nationwide
Inpatient Sample (NIS). 2013. http://www.ahrq.gov/research/index.html.
Accessed 12 October 2015
REFERENCES
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 24
31. Woolf AD, Pfleger B. Burden of major musculoskeletal conditions.
Bulletin of the World Health Organization. 2003;81(9):646-656.
32. Sernbo I, Johnell O. Consequences of a hip fracture: a prospective study
over 1 year. Osteoporosis international : a journal established as result
of cooperation between the European Foundation for Osteoporosis and
the National Osteoporosis Foundation of the USA. 1993;3(3):148-153.
33. Rodak S. How bundled payments in orthopedics can help build the
foundation of a center of excellence. Becker Hospital Review;
February 6, 2013.
34. Barwick JF, Nowotarski PJ. Femur Shaft Fractures (Broken Thighbone).
2011. Accessed http://orthoinfo.aaos.org/topic.cfm?topic=A00521.
35. The Advisory B. Reshaping the market around clinical preferences.
2011. Accessed 23 June 2015.
36. Herman B. 11 ways hospitals and health systems can increase
profitability in 2013. Becker's Hospital Review; November 26, 2012.
37. Palmer SJ, Parker MJ, Hollingworth W. The cost and implications of
reoperation after surgery for fracture of the hip. The Journal of Bone
and Joint Surgery. British volume. 2000;82(6):864-866.
38. Kellam JF. Intertrochanteric hip fractures. 2014. http://emedicine.
medscape.com/article/1247210-overview. Accessed 1 May 2014.
39. Parker MJ, Handoll HH. Gamma and other cephalocondylic
intramedullary nails versus extramedullary implants for extracapsular hip
fractures in adults. The Cochrane database of systematic reviews.
2010(9):1-240.
40. American academy of orthopaedic surgeons. Management of hip
fractures in elderly: evidence-based clinical practice guideline.
September 5, 2014.
41. Desai SJ, Wood KS, Marsh J, Bryant D, Abdo H, Lawendy AR, Sanders
DW. Factors affecting transfusion requirements after hip fracture: can
we reduce the need for blood? Can J Surg. 2014; 57(5):342-348.
42. Jackman JM, Watson JT. Hip fractures in older men. Clin Geriatr Med.
2010; 26(2):311-329.
43. Pena OR, Gomez-Gelvez A, Espinosa KA. Clinical implications of
impingement of the anterior femoral cortex after cephalomedullary
nailing. Injury. 2016;47(10):2300-2306.
44. Kleweno C, Morgan J, Redshaw J, et al. Short versus long
cephalomedullary nails for the treatment of intertrochanteric hip
fractures in patients older than 65 years. Journal of orthopaedic
trauma. 2014;28(7):391-397.
45. Georgiannos D, Lampridis V, Bisbinas I. Complications following
Treatment of Trochanteric Fractures with the Gamma3 Nail: Is the Latest
Version of Gamma Nail Superior to Its Predecessor? Surgery Research
and Practice. 2014;2014:6.
46. Zimmer Natural Nail Brochure. 2010.
47. Ostrum RF, Levy MS. Penetration of the distal femoral anterior cortex
during intramedullary nailing for subtrochanteric fractures: a report of
three cases. Journal of orthopaedic trauma. 2005;19(9):656-660.
48. Bazylewicz DB, Egol KA, Koval KJ. Cortical encroachment after
cephalomedullary nailing of the proximal femur: evaluation of a more
anatomic radius of curvature. Journal of orthopaedic trauma.
2013;27(6):303-307.
49. DePuy Synthes Trauma. Data on File. Design Review Files: 0000095553
Head Element and 0000098188 Fenestrated Head Element. 2014.
50. Windolf M, Muths R, Braunstein V, Gueorguiev B, Hanni M, Schwieger
K. Quantification of cancellous bone-compaction due to DHS Blade
insertion and influence upon cut-out resistance. Clinical biomechanics.
2009;24(1):53-58.
51. Abdulkareem IH. A review of tip apex distance in dynamic hip screw
fixation of osteoporotic hip fractures. Nigerian Medical Journal: Journal
of the Nigeria Medical Association. 2012;53(4):184-191.
52. Sommers MB, Roth C, Hall H, et al. A laboratory model to evaluate
cutout resistance of implants for pertrochanteric fracture fixation.
Journal of orthopaedic trauma. 2004;18(6):361-368.
53. Lenich A, Bachmeier S, Prantl L, et al. Is the rotation of the femoral
head a potential initiation for cutting out? A theoretical and
experimental approach. BMC musculoskeletal disorders. 2011;12:79.
54. Simmermacher RKJ, Ljungqvist JL, Bail H, Hockertz T, Vochteloo AJH,
Ochs U, Werken ChrVD. The new proximal femoral nail antirotation
(PFNA) in daily practice: results of a multicentre clinical study. Injury.
2008;39:932-939.
55. Lenich A, Vester H, Nerlich M, Mayr E, Stockle U, Fuchtmeier B. Clinical
comparison of the second and third generation of intramedullary
devices for trochanteric fractures of the hip--Blade vs screw. Injury.
2010;41(12):1292-1296.
56. Mingo-Robinet J, Torres-Torres M, Martinez-Cervell C, et al.
Comparative study of the second and third generation of gamma nail
for trochanteric fractures: review of 218 cases. Journal of orthopaedic
trauma. 2015;29(3):e85-90.
57. Augat P, Rapp S, Claes L. A modified hip screw incorporating injected
cement for the fixation of osteoporotic trochanteric fractures. Journal
of orthopaedic trauma. 2002;16(5):311-316.
58. Lindner T, Kanakaris NK, Marx B, Cockbain A, Kontakis G, Giannoudis
PV. Fractures of the hip and osteoporosis: the role of bone substitutes. J
Bone Joint Surg Br. 2009;91(3):294-303.
59. Dall’Oca C, Maluta T, Moscolo A, Lavini F, Bartolozzi P. Cement
augmentation of intertrochanteric fractures stabilised with
intramedullary nailing. Injury 2010; 41(11):1150-1155.
60. Goffin JM, Pankaj P, Simpson AH, Seil R, Gerich TG. Does bone
compaction around the helical blade of a proximal femoral nail
anti-rotation (PFNA) decrease the risk of cut-out?: A subject-specific
computational study. Bone and Joint Research. 2013; 2(5):79-83.
REFERENCES
25
61. DePuy Synthes Trauma. Data on file. Clinical evaluation of trochanteric
fixation nail advanced. Document number: 0000087418; Version A.34.
2014.
62. Chen CE, Weng LH, Ko JY, Wang CJ. Management of nonunion
associated with broken intramedullary nail of the femur. Orthopedics.
2008;31(1):78.
63. ASTM. Designation: F1295-11Standard Specification for Wrought
Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications
(UNS R56700). 2011.
64. ASTM. Designation: F136 − 13 Standard Specification for Wrought
Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for
Surgical Implant Applications (UNS R56401). 2013.
65. DePuy Synthes Trauma. Data on file. Implant Materials: Wrought
Titanium - 15% Molybdenum, 2nd ed. 2003.
66. DePuy Synthes Trauma. Data on file. Implant Materials: Titanium-6%
Aluminum-7% Niobium, 2nd ed. 1993.
67. Bushelow M, Kmiec S, Shultzabarger B, McMillan R, Coombs D, Blauth
M. Use of Finite Element Analysis to Predict the Fatigue Strength of
Cephalomedullary Nail Systems. Paper presented at: Orthopedic
Research Society; March 28-April 1, 2015; Las Vegas, NV.
68. Kuzyk P, Shah S, Zdero R, Olsen M, Waddell J, Schemitsch E. A
biomechanical comparison of static versus dynamic lag screw modes
for cephalomedullary nails used to fix unstable peritrochanteric
fractures. Journal of Trauma and Acute Care Surgery.
2012;72(2):E65-E70.
69. Shultzabarger B, Pappalardo D, Bushelow M, Harris R. Comparison of
Statically Locked Proximal Lag Screws in Cephalomedullary Nail
Systems. Paper presented at: Orthopedic Research Society; March
28-April 1, 2015; Las Vegas, NV.
70. DePuy Synthes Trauma. data on file. MT15-273 TFNA Pre/Post Fatigue
Sliding Data Analysis. 2015.
71. Lerner J, Menzie AM, Rodriguez S, Sparks CY. 90-day direct medical
resource utilization after intramedullary fixation of pertrochanteric hip
fractures. PMS39 Annual ISPOR EU Nov 01 2016.
72. Association for Professionals in Infection Control and Epidemiology.
Guide to the elimination of orthopedic surgical site infections. 2010.
73. Centers for Disease Control and Prevention: Guideline for Disinfection
and Sterilization in Healthcare Facilities. 2008.
74. Close JD, Swartz K, Deu R. Hip fracture in older patients: tips and tools
to speed recovery. J Fam Pract. 2013; 62(9):484-492.
75. Kim SH, Meehan JP, Blumenfeld T, Szabo RM. Hip fractures in the
United States: 2008 nationwide emergency department sample.
Arthritis Care Res. 2012; 64(5):751-757.
76. Carpintero P, Caeiro JR, Carpintero R, Morales A, Silva S, Mesa M.
Complications of hip fractures: a review. World J Orthop. 2014;
5(4):402-411.
77. Cummings SR. Rubin SM, Black D. The future of hip fractures in the
United States. Numbers, costs and potential effect of postmenopausal
estrogen. Clin Orthop Relat Res. 1990;252:163-166.
78. Baumgaertner MR, Curtin SL, Lindskog DM, Keggi JM. The value of the
tip-apex distance in predicting failure of fixation of peritrochanteric
fractures of the hip. Journal of Bone & Joint Surgery. 1995; 77:
1058-1046.
TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 26
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