Pathological Fractures - Nov 2013

7/21/2019 Pathological Fractures - Nov 2013

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PREVENTION OF PATHOLOGICAL

FRACTURE

AUDIT RESULTS & NEW STANDARDS & GUIDELINES14THNOVEMBER 2013PREVENTION OF PATHOLOGICAL FRACTURE (PPF) GUIDELINE DEVELOPMENT GROUP

DR MARIA DEBATTISTA

PAULA HORTON

SUSAN HOWARTH

BARBARA HUMPHRIES

DR ANDREW KHODABUKUS

JOANNE REYNOLDS

DR JENNY SMITH

MR PAUL COOL

DR AZMAN IBRAHIM


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PRESENTATIONJULY 2012

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SESSION OUTLINE

Overview

Existing Standards & Audit

Results

Updated Standards &

Guidelines

Mr Paul Cool - ExternalReview


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PROVENANCE

April 2005 initial guidelines produced

3rdMay 2012 Review meeting of MCPCNAG,majority quorate vote to review guidelines

Meetings of membership of Prevention ofPathological Fracture (PPF) guideline developmentgroup

17thJuly 2012

25thSeptember 2012

13thNovember 2012

11thJune 2013

12thSeptember 2013

16thOctober 2013

4thNovember 2013

Presentation of Literature Review on 4thJuly 2013


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LITERATURE REVIEW

Main changes to evidencebase:

Mirels Score

upgraded to Level 2+ evidence Denosumab licensed for PPF

Breast cancer and solid tumours ifbisphosphonates would otherwise

be prescribed Not used in prostate cancer

Level 1+ Evidence


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EXISTING STANDARDS & AUDITRESULTS


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DATA COLLECTION

Period

13thFebruary 201326thApril

2013

Collection Method

Case Note Audit

Evaluation of ProfessionalPractice

Disseminated to all ICNs


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CASE NOTE REVIEW

EVALUATION OF PROFESSIONAL

PRACTICE


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DEMOGRAPHICSEVALUATION OF PROFESSIONAL PRACTICE

38 Responses

8 ICNs

CNS 21 (55%), Doctors 17 (45%)


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DEMOGRAPHICSCASE NOTE REVIEW

69 Responses

6 ICNs, CNS 22 (32%), Doctors 37 (68%)


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N = 68

TotalResponses= 157 as

multiplemetastasesin some

9 (13%)

had bonepain and noknownmetastases


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Pain

62 responses

4 had missing data

100% one pain 43.5% two

12.9% three

3.2% four

0% five

24 (36%)

21 (32%)

19 (29%)

12 (18%)

10 (15%)

5 (8%)4 (6%)

3 (5%) 21 1

0

5

10

15

20

25

30

Location of Pain


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STANDARD 1

Reports of bone pain should be promptly andappropriately investigated following British

Association of Surgical Oncology (BASO)

Guidelines. [Grade D]

Source: Breast Specialty Group of the British Association of Surgical Oncology. The management of metastatic bone disease in the

United Kingdom. Eur J Surg Oncol 1999: 25: 323


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ASSESSMENTBRITISH ASSOCIATION OF SURGICAL ONCOLOGY GUIDELINES

Level of clinical

suspicion of

metastatic disease

Clinical Features Action

Minimal

Known cause for pain.

Resolves well usually 23

weeks from onset

Normal outpatients review. Return to GP if resolution

not complete

LowProbable cause known. Good

resolution over 46 weeks.

Plain radiograph.

If negative: no action.

If positive: follow advice regarding the need fororthopaedic assessment.

ModerateNo clear cause for pain which is

persistent but not progressive.

Plain radiographs, serum calcium and bone scan

within 10 working days. Review one week later.

If all negative, review in 8 weeks if symptomatic.

If one or more tests positive, follow advice regarding

the need for orthopaedic assessment.

High

No identified cause for pain.

Night pain, severe and/or

progressive pain.

Neurological symptoms and

signs.

Plain radiographs, serum calcium and bone scanwithin 10 working days. Review one week later.

If all negative but suspicion high, review in 1 week

(appendicular skeleton). If pain in spine then arrange

MRI

If one or more tests positive, follow advice regarding

the need for orthopaedic assessment.

Source: Breast Specialty Group of the British Association of Surgical Oncology. The management of

metastatic bone disease in the United kingdom. Eur J Surg Oncol1999: 25: 323

Level 4Expert Opinion


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STANDARD 1EVALUATION OF PROFESSIONAL PRACTICE

What awareness is there of the BASO criteria?

6

11

21

Unsure/Seek further help Scoring System Clinical assessment0

5

10

15

20

25

How would you assess risk of bone disease and fracture?


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What awareness is there of the BASO criteria?

1

1

3

4

6

7

12

12

MSCC Guidelines

Trust Policy

BASO

NICE

MCCN Guidelines

Hartington

Mirels

None/Don't Know

0 2 4 6 8 10 12 14

What guidelines are you aware of that assess risk ofbone disease and pathological fracture?

Harrington


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STANDARD 1CASE NOTE REVIEW

WAS THE RISK OF METASTATIC BONE DISEASE ASSESSED?

28.8%(19)

0.0% (0)

0.0% (0)

0.0% (0)

0.0% (0)

37.9%(25)

37.9%(25)

0 5 10 15 20 25 30

Yes - risk assessed as probable metastaic disease butnot graded as one of options below

Yes - risk assessed according to BASO Guidelines as"minimal"

Yes - risk assessed according to BASO Guidelines as"low"

Yes - risk assessed according to BASO Guidelines as"moderate"

Yes - risk assessed according to BASO Guidelines as

"high"

No/Not documented

Not applicable-already known to have metastatic diseasein the area(s) of pain


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35 (57%)34 (55%)

33 (53%)

30 (48%)

22 (36%)

0

5

10

15

20

25

30

35

40

MRI scan CT scan Ca2+ & Alk Phos Plain radiograph (x-ray Isotope bone scan

What investigations has the patient had up to this assessmentdate?


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24 (39%)

14 (23%)

10 (16%)

8 (13%) 8 (13%)

5 (8%)

2 21

0

5

10

15

20

25

30

No-allappropriate

MRI scan Ca2+ & AlkPhos

Plainradiograph (x-

ray)

No - patienttoo unwell

CT Scan Isotope bonescan

No-reasonunclear

No-lowseverity/risk

What new investigations were organised after SPC assessment?


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28 (45%) 28 (45%)

8 (13%)

3 (5%) 3 (5%)

12 (19%)

0

5

10

15

20

25

30

Not applicable Increased pain Pain on weight-bearing

Pain at night Results of other investigations

Other symptoms orreasons

What prompted these investigations to be ordered or advised?


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Standard 1 Low knowledge of

BASO guidelines

Clinical reasoning isbetter

Reports of bone painshould be promptly

and appropriately

investigated following

British Association of

Surgical Oncology

(BASO) Guidelines.

[Grade D]




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STANDARD 2

Patients presenting with a lesion due to metastatic

bone disease must be discussed with an

oncologist for consideration of further therapy(e.g. hormonal manipulation, bisphosphonates,

chemotherapy, radiotherapy) regardless of

orthopaedic intervention. [Grade C]


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ORTHOPAEDIC ONCOLOGY


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PRESENTATIONJULY 2012V1.0

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Summary (from additional comments madeon questionnaire responses) Referral to an oncologist is likely to arise from a

combination of factors, primarily severe pain withradiological evidence of metastatic disease at thatsite.

Location is also a factor. Spinal disease,particularly where there is suspicion of impending

cord compression, is more likely to result in areferral than either upper or lower limb disease(74% compared to 55/56% respectively)


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11 (31%)

23 (64%)

7 (19%)

1 (2.8%)

0

5

10

15

20

25

Orthopaedic surgeon Oncologist None Missing Data

What discussions took place when investigations were completed?


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Standard 2 Evaluation of

professional practice

less than 100%

Case note analysis64%

But impact of poor

performance status

(affecting 35% of

sample)

Patients presentingwith a lesion due to

metastatic bone

disease must be

discussed with an

oncologist for

consideration of

further therapy (e.g.

hormonalmanipulation,

bisphosphonates,

chemotherapy,

radiotherapy)

regardless of

orthopaedic

intervention. [GradeC]


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STANDARD 3

If there is evidence of significant risk of apathological fracture, orthopaedic review should

be urgently sought and the patient seen within

one week. [Grade D]



British Orthopaedic Association Working Party on Metastatic Bone Disease. Metastatic Bone Disease: A Guide to Good Practice. London.

2001.


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ALL DISCUSSED WITHORTHOPAEDICS

N = 11

Hospital 9 (82%),Community 1 (9%), Hospice

1 (95) 5 clearly discussed with

them within 1 week, 6 hadmissing data

Outcome 4 (36%) had treatment

4 (36%) none needed

2 (18%) poor PS

1 (9%) patient declined op

WHEN THERE WAS AN OVERTRISK GRADING

N = 1

Mirels of 8 graded by

ortho SHO Discussed within 1 week

Offered IM nail but patient

declined


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Standard 3 From data all had an

urgent orthopaedic

review

Hospital bias?

If there is evidence ofsignificant risk of a

pathological fracture,

orthopaedic review

should be urgently

sought and the

patient seen within

one week. [Grade D]


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STANDARD 4

When a fracture is likely to occur, prophylacticfixation, appropriate to the site of the lesion,

should be performed prior to treatment with

radiotherapy. [Grade D]

Source: Mirels H. Metastatic disease in long bones. A proposed scoring system for diagnosing impending pathological fracture. Clin

Orthop Rel Res 1989; 249: 256-264.


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Orthopaedic procedures in last 12 months

Procedure Number of responses

Femoral nail4

(2 bilateral, 1 post fracture on 1 side)

Total hip replacement1

(after fracture)

Nail of humerus3

(1 offered post fracture)

Vertebroplasty

2

(1 post spinal fracture)

Amputation 1

NOS IM nail 1

Other commentsusually too poorly to have treatment


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Weeks38%

Months31%

Last Days oflife

31%

If so how long should that prognosis be?

45%

24%

21%

Yes No Unsure

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Do you think there is a minimal likelyprognosis needed for referral to an

orthopaedic surgeon to be appropriate?


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N = 3

IM Nail of humerus, IM nail of femur,

curettage and cementoplasty of femur

1 had radiotherapy, 2 did not due to

performance status


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Standard 4 All had consideration

re: radiotherapy

When a fracture islikely to occur,

prophylactic fixation,

appropriate to the

site of the lesion,

should be performed

prior to treatment

with radiotherapy.

[Grade D]


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STANDARD 5

Following any orthopaedic intervention

(prophylactic stabilisation or fracturemanagement) a patient must be discussed with

an oncologist regarding the possibility of further

therapy. [Grade D]




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Treatment Percentage

Single Fraction Radiotherapy 86.8%

Multiple fraction Radiotherapy 73.7%

Bisphosphonate Therapy 92.1%

Denosumab 23.7%

Other

10.5%

What oncological treatments to reduce risk of pathological

fractures have your patients received in the last 12 months?


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39%

36%

9%

Yes No Unsure

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

Do you think there is an appropriateminimal prognosis for referral to an

oncologist?

Few weeks62%

1-3 months30%

> 3 months8%

If so how long should that prognosis be?


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N = 3

IM Nail of humerus, IM nail of femur,

curettage and cementoplasty of femur

1 already on biologic agent, 2 did not due

to performance status


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Standard 5 All had consideration

re: chemotherapy

Following anyorthopaedic

intervention

(prophylactic

stabilisation or

fracture

management) a

patient must be

discussed with anoncologist regarding

the possibility of

further therapy.

[Grade D]


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REVISED GUIDELINES FOR

THE PREVENTION OF

PATHOLOGICAL FRACTURESIN PALLIATIVE

CARE


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1.GENERAL PRINCIPLES (1)

Bone is one of the commonest sites of metastatic

disease. The most likely primary tumours to spread

to bone are breast, bronchus, kidney, thyroid and

prostate. The axial skeleton (skull, ribs, spine and

pelvis) is more likely to develop metastatic disease

than the appendicular skeleton. l

The major associated morbidities of bone metastasesinclude pain (the most common symptom occurring

in 70% of patients), pathological fractures (occurring

in 8-30% of patients) and hypercalcaemia.2,3

Advances in hormonal treatments, use of

bisphosphonates and chemotherapy treatments have

meant that the prognosis of patients with bone

metastases, without visceral metastatic disease, has

greatly improved. 4

1 GENERAL PRINCIPLES (2)


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1.GENERAL PRINCIPLES (2)

Survival rates for people with bone metastases vary

depending on the primary tumour type. In breast

cancer, median survival is 24 months with a 5-year

survival rate of 20% and in prostate cancer there is a5-year survival rate of 25% and a median survival of

40 months5.

Prediction of pathological fractures before the event

is a relevant clinical problem. Prophylactic fixation oflong bone metastases is generally easier for the

surgeon and less traumatic for the patient.

Therefore, prophylactic fixation of long bones prior

to radiotherapy should be considered. Stabilisation

of impending pathological fractures is likely to result

in shorter hospital stays, with patients more likely tobe discharged to their own homes.9

The prevention and management of pathological

fractures should be within the context of a multi-

disciplinary team. 5,10


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2. GUIDELINES

2.1 Investigation of bone pain (1)


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Pain may be described as a dull ache to a deep

intense pain; pain at rest; pain exacerbated by weight

bearing and importantly, pain which is worse at night.2Patients should be encouraged to report skeletal

symptoms promptly.4

Bone pain may be due to structural damage,

periosteal irritation, nerve entrapment or secretion of

chemical mediators causing osteolysis e.g.prostaglandins and cytokines. These mediators

activate both osteoclasts and nociceptors.2

The clinical conundrum is to determine which pains

are due to new or existing metastatic disease and

which of these lesions may progress to a pathological

fracture.As such, reports of bone pain should be

investigated following the British Association of

Surgical Oncology (BASO) Guidelines (see Table 2.1).10[Level 4]

BASO GUIDELINES FOR THE INVESTIGATION OF


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BONE PAIN10[LEVEL 4]

Level of clinical suspicion of

metastatic disease

Clinical features

Action

Minimal

Known cause for pain.

Resolves well usually 2-3

weeks from onset.

Normal outpatient review.

Return to GP if resolution not

complete.

Low

Probable cause known. Good

resolution over 4-6 weeks.

Plain radiograph. If negative:

no action.

If positive: follow advice

regarding the need for

orthopaedic assessment.

Moderate

No clear cause for pain whichis persistent but not

progressive.

Plain radiographs, serum

calcium and bone scan within

10 working days. Review one

week later.

If all negative, review in 8

weeks if symptomatic.

If one or more tests positive,

follow advice regarding the

need for orthopaedic

assessment.

High

No identified cause for pain.

Night pain, severe and / or

progressive pain.

Neurological symptoms and

signs.

Plain radiographs, serum

calcium and bone scan within

10 working days. Review one

week later.

If all negative but suspicion

high, review in 1 week

(appendicular skeleton). If

pain in spine, then arrange

MRI.

If one or more tests positive,

then follow advice regarding

need for orthopaedic

assessment.

2 1 Investigation of bone pain (2)


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Plain radiographs should be of the entire bone,

including the joint above and below the site of pain.

Specific radiographs should be centralised over thepainful area in an AP and lateral view.

Bone metastases may be described as osteolytic (bone

appears less dense on imaging), osteoblastic (where

bone looks denser or whiter on imaging) or mixed in

nature.4 [Level 4]

Any plain radiograph report that details the presence of

a lytic lesion in a long bone should be discussed with a

radiologist regarding its size and degree of cortical

involvement, if not already stated. 7, 8, 10[Level 4]

Plain radiographs are relatively insensitive at detecting

bone metastases.19Thus if clinical suspicion is highand radiographs are normal, further imaging is

warranted. This should be an isotope scan if the

appendicular skeleton is suspected, and an MRI if the

spine is potentially involved.19


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Areas of increased uptake in any long bones on anisotope bone scan should be followed up by plain

radiographs of the whole bone in two planes at 90 to

each other, to assess for size and cortical

involvement.10[Level 4]

Patients with symptomatic bone metastases shouldbe referred urgently to an orthopaedic clinic or be

discussed at a site-specific multidisciplinary team

meeting if they have any of the following:

Structurally significant bone destruction.Uncertainty whether the destruction is

significant.

Pain of sudden onset (or change in character)

that is exacerbated by movement.10[Level 4]

PREDICTION OF PATHOLOGICAL


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PREDICTION OF PATHOLOGICAL

FRACTURE

Clinical features of impending pathological fractureinclude pain on movement, persistent pain and

increasing pain. Pain in an area which has already

been treated with radiotherapy, but has not

responded, may also be considered as a clinical

indicator of possible impending fracture.7,8

The risk of a pathological fracture occurring, and

therefore the need to consider prophylactic

fixation, may be assessed using either Mirels

scoring system (for use in long weight bearing

bones) or Harrington's classic definitions (use

restricted to the proximal femur).7

In Mirels scoring system (Table 32.2) [Level 2+], the

maximum possible score is 12. If a lesion scores 8

or above, then prophylactic fixation is

recommended pr ior to radiotherapy.


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Table 32.2 Mirels scoring system for the prediction of

pathological fractures 6[Level 2+]

ScoreClinicalfeatures

1 2 3

Site Upper limb Lower limb Peritrochanter

ic

Pain severity Mild Moderate Functional

Type of lesion Blastic Mixed Lytic

Size (Maximumdestruction of cortexin any view as seen on

plain x-ray)

2/3


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ANY ONE OF HARRINGTON'S CLASSIC DEFINITIONS

INDICATES A HIGH RISK OF PATHOLOGICAL

FRACTURE IN THE PROXIMAL FEMUR (SEE TABLE

2.3).8[LEVEL 3].

Table 2.3 Harrington's classic definitions. Risk of a pathological fracture 8 [Level 3]

1. 50% of circumferential cortical bone has been destroyed.

2. Where pain with weight bearing stresses persists, increases or recurs, despiteadequate localirradiation.

3. Lesions in the proximal femur in excess of 2.5cm in any dimension.

4. Lesions in the proximal femur associated with avulsion of the lesser trochanter.


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2.3 ROLE OF ORTHOPAEDIC SURGEON

A lead orthopaedic surgeon for appendicular

metastatic bone disease should be identified in

each local NHS trust. 4[Level 4]

Referral to an orthopaedic surgeon is appropriate in

the following situations:

Prophylactic fixation of metastatic deposits

when there is a high risk of fracture i.e.Mirelsscore equal or greater than 8 (see Table 32.2) or

the presence of any one of Harrington's classic

definitions (see Table 32.3).

Stabilisation or reconstruction after

pathological fracture.

Decompression of the spinal cord and nerve

roots and / or stabilisation for spinal

instability. 4[Level 4] (see Guidel ines on the

Management of Metastat ic Spinal Cord

Compress ion).


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2.4 RADIOTHERAPY

Radiotherapy has a major role in the treatment of

bone metastases. 70% of patients will achieve pain

relief with palliative external beam radiotherapy. It

may also prevent additional bone destruction, help

to maintain function, prevent neurologicalcompromise and maintain qualityof life.6

Following nailing of a bone, radiotherapy should be

considered by appropriate specialists

within the context of the multidisciplinary team. 5, 11,

12[Level 2-]

2.5 OTHER TREATMENT MODALITIES (1)


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( )

Bisphosphonates should be considered, where

clinically appropriate, for the prevention of

skeletal related events and treatment of malignantbone pain in patients with bone metastases

from breast cancer or hormone refractory prostate

cancer, and also patients with multiple

myeloma.13[Level 1+] Decisions to treat should be

based on an assessment of their general

medical condition and expected survival time (seeGuidel ines on the Use of Bisphos phonates in

the Management of Malignant Bone Disease).

[Level 4].

Radiofrequency ablation of bone metastases is anemerging alternative therapy for the

management of bony metastatic disease. Referral to

an appropriate specialist may be beneficial

for effective pain palliation and local control of

disease. 15[Level 3]


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2.5 OTHER TREATMENT MODALITIES (2)

Percutaneous cementoplasty is indicated forpatients with painful vertebral metastases. It is a

minimally invasive technique involving injection of

polymethylmethacrylate to strengthen a

vertebra. It may provide fast pain relief for patients

when traditional surgical options are considered to

be too invasive.16,17

[Level 3] Denosumab is recommended as an option for

preventing skeletal-related events from breast

cancer and from solid tumours, if bisphosphonates

would otherwise be prescribed. It can be used in

poor renal function. It is however not

recommended by NICE for use in prostate cancer,and carries the risk of potential osteonecrosis of

the jaw5. [Level 1+]

2 3 STANDARDS


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2.3 STANDARDS1. Reports of bone pain should be promptly and

appropriately investigated following British

Association of Surgical Oncology (BASO) Guidelines.10

[Grade D].

2. If there is evidence of significant risk of a pathological

fracture, urgent orthopaedic review should be

considered.4, 10[Grade D]

3. Following any orthopaedic intervention (prophylactic

stabilisation or fracture management) a patient shouldbe discussed with an oncologist regarding the

possibility of further therapy.10

[Grade D]

4. Patients presenting with a NEW OR SYMPTOMATIC

lesion due to metastatic bone disease must be

discussed with an oncologist for consideration of

further therapy (e.g. hormonal manipulation,

bisphosphonates,chemotherapy, radiotherapy)

regardless of orthopaedic intervention.10[Grade C]

2 4 REFERENCES (1)


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2.4 REFERENCES (1)

Tubiana-Hulin M. Incidence, prevalence and distribution of bone

metastases. Bone 1991; 12(Suppll):S9-S10.

Mercadante S. Malignant bone pain. Pathophysiology and treatment. Pain

1997; 69: 1-18.

Orthoteers Orthopaedic resource. Bone metastases. Available from

www.orthoteers.orgUpdated 29 May 2009. [Last accessed 1 June 2009]

British Orthopaedic Association Working Party on Metastatic Bone Disease.

Metastatic Bone Disease: A Guide to Good Practice. London. 2001.

NICE (2012) Denosumab for prevention of skeletal related events in adults

with bone metastases from solid tumours Accessed electronically at

http://www.nice.org.uk/nicemedia/live/13939/61129/61129.pdf Frassica DA. General principles of external beam radiation therapy for

skeletal metastases. Clin Orthop Rel Res 2003; 415 (Suppl): S158-164.

Mirels H. Metastatic disease in long bones. A proposed scoring system for

diagnosing impending pathological fracture. Clin Orthop Rel Res 1989; 249:

256-264.

Harrington KD. Impending pathological fractures from metastatic malignancy:

evaluation andmanagement. Instr Course Lect 1986; 35: 357-381. Ward WG, Spang J, Howe D, Gordan S. Femoral recon nails for metastatic

disease:

Indications, technique and results.AmJOrthop 2000; 29(9 Suppl): 34-42.

Breast Specialty Group of the British Association of Surgical Oncology. The

management ofmetastatic bone disease in the United Kingdom. Eur JSurg

Oncol 1999; 25: 3-23

2 4 REFERENCES (2)
http://www.orthoteers.org/http://www.nice.org.uk/nicemedia/live/13939/61129/61129.pdfhttp://www.nice.org.uk/nicemedia/live/13939/61129/61129.pdfhttp://www.nice.org.uk/nicemedia/live/13939/61129/61129.pdfhttp://www.orthoteers.org/


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2.4 REFERENCES (2)

Saarto T, James R, Tenhunen M, Kouri M. Palliative radiotherapy in the treatment of

skeletalmetastases. Eur J Pain 2002; 6(5): 323-330.

Townsend PW, Smalley SR, Cozad SC, Rosenthal HG, Hassanein RES. Role of

postoperative radiation therapy after stabilisation of fractures caused by metastaticdisease. Int J Radiat Oncol Biol Phys 1995; 31: 43-49.

Wong R, Wiffen PJ. Bisphosphonates for the relief of pain secondary to bone

metastases. Cochrane Database of Systematic Reviews 2002. Issue 2. Art

No.:CD002068. DOI:10.1002/14651858. CD002068.

Rosen LS, Gordon D, Tchekmedyian S, Yanaghihara R, Hirsh V, Krzakowski M et al.

Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with

lungcancer and other solid tumours: a phase III double blind randomised trial - the

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