TITLE: Direct Anterior Approach for Primary Total Hip ... · portion of the hip.1 The direct...

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TITLE: Direct Anterior Approach for Primary Total Hip Arthroplasty: A Review of Clinical Effectiveness and Cost-Effectiveness

DATE: 26 April 2016

Context and policy issues

Total hip arthroplasty (THA), commonly referred to as total hip replacement, is an elective orthopedic procedure performed on patients experiencing hip pain due to joint deterioration resulting from a number of arthritic conditions.1 THA is highly effective in alleviating pain, restoring hip function, and improving patients’ quality of life through the replacement of diseased joint surfaces (i.e., femoral head and acetabulum) with synthetic materials.1 In Canada, there were approximately 49,503 hospitalizations for hip replacements in 2013-2014, which represents a 19.1% increase since 2009-2010.2 Of all hip replacement procedures performed in 2013-2014, 76.7% (34,424) were total hip replacements; the remainder comprised partial hip replacements and revision surgeries. If current trends persist, the volume and demand for hip replacement procedures is likely to increase with Canada’s growing and aging population. A number of surgical approaches for THA have been described for use in clinical practice. These primarily include the direct lateral, posterior, and direct anterior approaches, although other surgical techniques have also been developed and promoted. More specifically, the posterior approach (also called the posterolateral or Kocher-Lagenbeck approach) is a muscle-splitting technique during which access to the hip joint is gained posteriorly by splitting the gluteus maximus muscle and separating off the short external rotator muscles on the rear portion of the hip.1 The direct lateral approach (also called the Hardinge or modified Hardinge approach) is another muscle-splitting technique for THA; during this procedure, exposure to the hip joint is gained by dissecting the front portion of the hip abductor muscles, which in turn provides access to the hip through the anterior hip capsule.1 In contrast with the posterior or lateral approaches, the direct anterior approach (also called the Smith-Petersen, Hueter, or anterior supine intermuscular [ASI] approach) is a minimally invasive procedure that provides access to the hip without detaching any muscles or tendons.1,3 During this muscle-sparing procedure, the patient is positioned in the supine position and an intermuscular separation is created between the tensor fascia lata and sartorious muscles in order to access the hip joint through the anterior hip capsule.1,4 Several benefits related to the direct anterior approach for THA have been described in the published literature, including quicker functional recovery,

Direct Anterior Arthroplasty 2

reduced post-operative pain, and lower risk of post-operative dislocations when compared with the lateral or posterior approaches4-7; however, the direct anterior technique may also be associated with a unique set of complications.8,9 The purpose of this report is to examine the clinical effectiveness and cost-effectiveness of the direct anterior approach, as compared with the lateral and posterior approaches, for patients undergoing primary THA. Research Questions

1. What is the clinical effectiveness of the direct anterior approach for patients undergoing

primary total hip arthroplasty?

2. What is the cost-effectiveness of the direct anterior approach for patients undergoing primary total hip arthroplasty?

Key Findings

Three systematic reviews and one non-randomized study were identified relating to the clinical effectiveness of the direct anterior approach for patients undergoing primary total hip arthroplasty, as compared with the lateral or posterior surgical approaches. Based on the identified published literature, the direct anterior approach appears to be associated with favourable short-term patient outcomes, including faster functional recovery and lower perceived pain postoperatively, as well as a shorter length of hospital stay following surgery. Similarly, safety data suggests that the direct anterior approach is well tolerated and associated with an early risk of complications comparable to the lateral and posterior approaches. However, sustained benefit of short-term clinical outcomes and safety over a longer term is unclear. No relevant published literature was identified regarding the comparative cost-effectiveness of the direct anterior approach versus the lateral or posterior approaches for patients undergoing primary total hip arthroplasty. Methods

Literature Search Methods

A limited literature search was conducted on key resources including PubMed, The Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases, ECRI, Canadian and major international health technology agencies, as well as a focused Internet search. No filters were applied to limit the retrieval by study type. Where possible, retrieval was limited to the human population. The search was limited to English language documents published between January 1, 2011 and March 31, 2016. Rapid Response reports are organized so that the evidence for each research question is presented separately.


Selection Criteria and Methods

One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.

Table 1: Selection Criteria

Population Patients of all ages undergoing primary THA Intervention Direct anterior approach for primary THA Comparator Lateral or posterior approach for primary THA Outcomes Q1: Clinical effectiveness (e.g., recovery time, pain, patient

satisfaction, length of hospital stay, functional measures); Harms (e.g., nerve dysfunction, intraoperative fracture, postoperative dislocation, wound complications, rate of revision) Q2: Cost-effectiveness outcomes (e.g., incremental cost per QALY gained)

Study Designs Health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, non-randomized studies, economic evaluations

THA = total hip arthroplasty; QALY = quality-adjusted life year

Exclusion Criteria

Articles were excluded if they did not meet the selection criteria outlined in Table 1, they were duplicate publications, or were published prior to 2011. Studies relating to revision surgery only or those which compared the direct anterior approach with the mini-posterior, two-incision, or direct superior approach for THA were also excluded. In addition, health technology assessment reports, systematic reviews (SR), and meta-analyses were excluded if there was incomplete reporting of methods or if they were superseded by an updated review or more recent rigorous review. Randomized controlled trials (RCT) and non-randomized studies (NRS) were excluded if they were described within a SR selected for inclusion in this review. Critical Appraisal of Individual Studies

The quality of included studies was carefully assessed based on their study design. Systematic reviews and meta-analyses were critically appraised using the AMSTAR instrument,10 while the methodological quality of randomized and non-randomized clinical studies was assessed using the Downs and Black checklist.11 Summary scores were not calculated for the included studies; rather, a review of the strengths and limitations of each included study was performed and described narratively.


Summary of Evidence Quantity of Research Available

A total of 491 citations were identified in the literature search. Following screening of titles and abstracts, 469 citations were excluded and 22 potentially relevant reports from the electronic search were retrieved for full-text review. Two potentially relevant publications were retrieved from the grey literature search. Of these potentially relevant articles, 20 publications were excluded for various reasons, while 4 publications met the inclusion criteria and were included in this report. Appendix 1 presents the PRISMA flow diagram of the study selection process, including reasons for exclusion of full-text publications. Summary of Study Characteristics

A brief overview of the studies selected for inclusion can be found in Appendix 2: Characteristics of Included Publications. Study Design Three SRs

12-14, two with meta-analysis

13,14, and one non-randomized study (retrospective

cohort)15 were identified regarding the comparative clinical effectiveness and safety of the direct anterior approach versus the lateral or posterior approaches for primary THA. There was overlap among the primary comparative studies included in the three published SRs identified for inclusion (Appendix 3: Overlap among Studies Included in Systematic Reviews and Meta-Analyses). Twenty-seven studies were common to at least two SRs, while the rest were unique to a single SR. Inconsistency in studies selected for inclusion across these reviews likely occurred due to differences in chosen comparators and the search timeframes used; all SRs included data from randomized and non-randomized studies. No relevant published economic evaluations were identified relating to the cost-effectiveness of alternative surgical approaches for THA. Country of Origin The three included SRs were conducted in the Netherlands,12 United States,13 and China,14 respectively. The non-randomized study was conducted in Japan.15 Patient Population All of the included SRs12-14 and one non-randomized study15 comprised patients of all ages undergoing primary THA. One systematic review

12 indicated osteoarthritis as a pre-operative

diagnosis for study eligibility; however, it did not appear to restrict the inclusion of clinical studies which recruited patients with other underlying arthritic conditions. These included patients with avascular necrosis, rheumatoid arthritis, femoral acetabular impingement, and slipped capital femoral epiphysis in addition to patients with osteoarthritis. The two other SRs13,14 included in this report did not limit their patient population by specific pre-operative diagnoses; yet, potential variation in the underlying conditions of included study samples was not reported. Conversely, the study sample from the selected non-randomized study15 mainly comprised patients with osteoarthritis, but also patients affected by osteonecrosis and rheumatoid arthritis.


Interventions and Comparators All included studies examined the comparative clinical effectiveness and safety of alternative surgical approaches for primary THA. Namely, one SR14 and one non-randomized study15 compared the direct anterior approach (DAA) for THA with the posterior approach (PA), while another SR compared the clinical effectiveness of the DAA with the lateral approach (LA).13 In the third SR, the DAA for primary THA was compared with both the lateral and posterior approaches, as well as other surgical techniques (i.e. mini-lateral, mini-anterolateral, mini-posterior, and posterior navigated approaches). In all cases, DAA was the main intervention of interest. Outcomes The number and type of outcome measures varied across studies included in this report; nonetheless, several clinical effectiveness and safety outcomes were common across all studies. Namely, measures of patient-reported post-operative pain and functional recovery were cited among all SRs; yet, while two SRs classified post-operative function as a primary outcome measure,

13,14 one SR ranked pain as a secondary outcome,

13 and one SR did not distinguish

between primary and secondary outcome measures.12 Other outcome measures common to all included reviews were the length of hospital stay, operative or surgery time, estimated blood loss and the need for transfusions, as well as post-operative complications, including the rate of dislocations and intra-operative fractures. Two SRs further considered post-operative gait analysis and markers or muscle inflammation and muscle damage as secondary outcomes.13,14 In contrast to the SRs, the non-randomized study focused on safety outcomes and reported on the post-operative rate of dislocation, implant survival rate with revision surgery, and post-operative complications.15 Summary of Critical Appraisal

A detailed overview of the strengths and limitations of each included study is presented in Appendix 4: Critical Appraisal of Included Publications. Systematic Reviews The included systematic reviews and meta-analyses were generally well-designed and had several strengths. In particular, all review authors performed a comprehensive literature search across several electronic databases, enforced duplicate article screening and duplicate extraction of data with a consensus procedure in case of disagreements, and provided a lis t of included studies and individual study characteristics. In addition, the methodological rigour and scientific quality of included studies was assessed across all reviews and considered appropriately in the analysis and formulation of conclusions. Where data were not statistically combined in a meta-analysis, the decision to not meta-analyze the results was justified. Despite the application of best practices in the conduct of systematic reviews, there were also some concerns relating to these studies. Namely, while one SR clearly stated that the research questions posed and inclusion criteria used were established a priori,14 it was unclear whether the authors of the two other SRs12,13 pre-defined the published research objectives or developed a review protocol in order to avoid bias in selecting studies during the review process. Furthermore, two SRs assessed the scientific quality of included studies using a non-validated instrument12,14; specifically, items from three previously published quality assessment tools were non-randomly selected and used for the appraisal of selected review studies. Two SRs were


further supplemented by a meta-analysis for certain outcome measures; however, methods for statistically combining data from randomized and non-randomized studies were not described by the review authors, and their decision to meta-analyze studies of different designs was not justified.12,13 This is especially concerning given the higher susceptibility to bias among non-randomized studies, as well as the differences among included study samples which may not allow for appropriate pooling of data. Finally, while the review authors’ potential conflicts of interest were clearly acknowledged in one review,14 sources of funding of included studies were not described by any review authors. Similarly, the likelihood of publication bias was not assessed in any of the included SRs. Non-randomized Studies The quality assessment of the included non-randomized study revealed that major concerns were associated with external validity, internal validity (confounding), and statistical power, while reporting and internal validity (bias) contributed to a lesser extent to the study’s overall risk of bias. More specifically, the study’s main limitation was the use of a non-random, historical cohort as a comparison group. Given that study participants in the intervention and comparison groups underwent THA via two surgical approaches (DAA versus PA) at two different time periods, the use of a historical cohort as comparison group may introduce a temporal bias and selection bias in the study population and ultimately affect the observed study outcomes. Furthermore, it was unclear whether the study participants were representative of the population from which they were recruited, limiting generalizability, and the procedural integrity or surgeon’s learning curve was not assessed between groups, which may also have influenced the assessed outcomes. Finally, adjustment for confounding was not carried out in the analysis, and no power calculation for determining adequate sample size was described. Summary of Findings

What is the clinical effectiveness of the direct anterior approach for patients undergoing primary total hip arthroplasty? The clinical effectiveness and safety of the direct anterior approach for THA, as compared with the lateral and posterior approaches, is summarized below based on selected outcomes from the included studies in this report. A detailed synthesis of the results of each included study is presented in Appendix 5: Main Study Findings and Author’s Conclusions. Post-operative Pain and Functional Recovery In the SR by Higgings et al.14 which compared DAA and PA for primary THA, the authors revealed that evidence from four studies suggested that DAA may provide potential short-term (2 weeks to 3 months) benefits in patient-reported pain (Visual Analogue Scale [VAS]) and function outcomes (Harris Hip Score [HHS], Hip disability and Osteoarthritis Outcome Score [HOOS], Western Ontario and McMaster Universities Arthritis Index [WOMAC]); however, no long-term difference between DAA and PA was found for these outcomes within these four studies, and an additional five clinical studies found no significant difference in pain and function between DAA and PA groups at any time points. A second SR by Yue et al.13 examined post-operative function and pain between patients undergoing primary THA via DAA versus LA techniques. The authors found that in comparison with the lateral approach, DAA led to better functional outcomes (HHS, WOMAC, Daily Activity


Questionnaire [DAQ]) among four included studies up to two years following surgery. However, they also revealed that three included studies found no significant difference in functional outcomes between DAA and LA at 1 year or 3.7 years (one study) after surgery. Moreover, Yue et al. found that four included studies reported significantly better pain scores postoperatively (VAS or Numerical Rating Scale) after DAA, as compared with LA, while two studies found no significant differences in pain scores between groups. Den Hartog et al.12 assessed post-operative pain and pain medication consumption, as well as functional recovery, in patients undergoing DAA for primary THA, as compared with the LA and/or PA surgical techniques. Results were reported narratively using an evidence grading system proposed by Guyatt et al.16 and Slavin et al.17 The authors found strong evidence (i.e. two or more high quality studies with 75% or more studies reporting consistent findings) from six included studies for significantly faster return to function and daily activity, significantly achieving functional milestones earlier, and significantly less time to postoperative recovery for patients undergoing DAA in comparison with lateral or posterior approaches; however, four out of six studies were rated as low quality. Moreover, five out of six included studies showed strong evidence that patients undergoing DAA for THA needed less assistive devices (e.g. cane, crutches, walker) for post-operative mobilization in comparison to patients operated through the posterior or lateral approaches; nonetheless, three studies were rated as low quality, and one study found no difference between DAA and LA or PA for this outcome. In terms of post-operative pain and pain medication consumption, Den Hartog et al. found conflicting evidence (less than 75% of the studies reported consistent findings) from mainly low quality studies: five studies found no difference in pain between DAA and LA or PA postoperatively, while eight studies (six rated as low quality) favoured DAA over LA or PA. Length of Hospital Stay (LOS) When comparing the DAA and lateral approaches for THA, Yue et al.13 found that hospitalization time for patients operated through the DAA was shorter by a mean of 1.19 days; this finding was derived from the pooled results of six studies (one RCT and five NRSs). Similarly, the pooled analysis of seven studies (one RCT and six NRSs) comparing DAA versus PA for primary THA by Higgins et al.14 revealed that post-operative hospital length of stay was shorter by a mean of 0.53 days. In contrast, Den Hartog et al. found conflicting evidence from mainly low quality studies relating to patients’ LOS following THA via DAA, as compared with LA or PA: 10 studies (seven rated as low quality) found no difference in post-operative LOS between DAA and LA or PA, while another 10 studies (seven rated as low quality) favoured DAA over LA or PA. Den Hartog et al. further suggested that LOS was related to the effect of surgeons’ learning curve for the DAA. Complication Rate In the SR by Yue et al.,13 treatment-related complications were defined as any perioperative surgical complications, including dislocations, intra-operative fracture, nerve palsy, cutaneous nerve palsy, superficial infection, deep infection, and post-operative hematoma. Based on the pooled results of three primary analyses, the authors found that DAA was statistically significantly associated with higher risk of cutaneous nerve palsy, as compared with the lateral approach for primary THA. Moreover, the authors found that DAA and LA were associated with a similar risk of dislocation (six studies), intra-operative fracture (six studies), nerve palsy (four studies), superficial infection (four studies), deep infection (five studies), and post-operative hematoma (four studies); however, these results were not statistically significant.


Higgins et al.14 assessed treatment-related complications following DAA versus PA for primary THA in terms of intra-operative fractures and rate of dislocation. Based on a pooled analysis of seven primary studies included in their review, the authors found no significant difference between groups in the rate of intra-operative fractures. Conversely, there was a statistically significant difference between groups in the number of post-operative dislocations favouring the DAA group according to the pooled results of seven comparative studies; namely, the odds of postoperative dislocations in patients operated through DAA was lower than in patients undergoing THA via PA. In the review by Den Hartog et al.,12 the authors assessed the post-operative complication rate within 17 surgical studies comparing DAA against LA or PA for primary THA, and reported their findings narratively. Thirteen studies found no difference between groups in terms of the complication rate, while two and three studies were in favour of and against the DAA, respectively. These findings are based on 12 low quality studies, as rated by the review authors. It was further suggested by the authors that the rate of treatment-related complications may be related to the effect of surgeons’ learning curve for the DAA. In the retrospective cohort study by Tsukada et al.,15 analysis revealed that the dislocation rate was significantly lower in the DAA group as compared with patients undergoing primary THA via PA. Namely, the authors found that no patients experienced post-operative dislocation in the DAA group by the final follow-up, while anterior dislocation occurred in three hips and posterior dislocation in four hips in the PA group. Moreover, one patient (0.7%) in the DAA group underwent revision surgery almost four years after the initial surgery, while six patients (3.4%) in the PA group underwent revision surgery. The authors additionally found no significant difference in the overall rate of post-operative complications between the two groups. The results of this single retrospective study warrant careful interpretation owing to the previously described limitations associated with the design of this study. What is the cost-effectiveness of the direct anterior approach for patients undergoing primary total hip arthroplasty? No relevant published literature was identified relating to the comparative cost-effectiveness of DAA versus LA or PA for patients undergoing primary THA. Limitations The systematic reviews and meta-analyses included in this report appeared well designed and addressed the research questions posed. However, certain factors related to these reviews, as well as the published literature which informed the study conclusions, may limit a clear interpretation of the results and their applicability to the Canadian setting. In particular, due to a limited number of RCTs relating to the clinical effectiveness and safety of DAA versus LA or PA for primary THA, review authors relied heavily on poor quality, non-randomized studies, many of which adopted a retrospective design. While non-randomized studies may help to inform the effectiveness and safety of different surgical approaches for patients undergoing primary THA in real-world clinical practice, these studies may also be susceptible to research biases which preclude a clear interpretation of findings. Although all review authors performed an assessment of the scientific quality of clinical studies selected for inclusion, the use of non-validated quality assessment tools within two systematic reviews is problematic given that this process limits the reproducibility of a study’s quality appraisal (i.e. different assessors may attribute different


quality ratings to the same study), and it is difficult to ascertain whether all potential sources of bias have been identified within the published literature selected for review. This may subsequently impact the formulation of study conclusions. Finally, the manner in which data from primary analyses were statistically combined in the meta-analyses included in this report lacks clarity and justification. Although it may be appropriate to statistically combine studies of different designs, the lack of justification for the decision to meta-analyze these data brings into question the validity and clinical meaningfulness of the results. The included non-randomized study may help to inform the safety of the direct anterior approach for primary THA in comparison with the PA; however, this study was limited by its retrospective design and its use of a historical cohort of patients as the comparison group, leading to concerns related to selection bias and confounding within the analysis. Therefore, these findings should be cautiously interpreted within the context of the larger body of evidence. Conclusions and Implications for Decision or Policy Making Based on the identified published literature, the DAA for primary THA may be associated with better early post-operative functional recovery, lower levels of perceived pain postoperatively, and a shorter hospitalization time following surgery, as compared with the lateral or posterior surgical approaches for THA; however, the sustained benefit of these short-term clinical outcomes following primary total hip replacement remains unclear. Moreover, while DAA appears to be associated with similar rates of surgical complications as the lateral and posterior approaches, and while DAA may provide potential safety benefits in the short-term, it is unclear whether any one approach leads to a better safety profile over a longer term. The comparative cost-effectiveness of these surgical approaches for patients undergoing primary THA warrants further study given the lack of identified published economic evaluations. Collectively, findings from three systematic reviews and one non-randomized study comparing patient outcomes following DAA versus LA and PA for primary THA appear insufficient to make conclusions about the clinical advantage of one surgical technique over another. The resultant uncertainty in the interpretation of results may be attributed to a number of limitations within the published literature, including concerns relating to the methods used to statistically combine primary clinical studies, as well as reliance on data from a large number of poor quality non-randomized studies. As a result, prospective studies with appropriate randomization procedures and adapted for the Canadian setting are required to address this evidence gap. PREPARED BY:

Canadian Agency for Drugs and Technologies in Health Tel: 1-866-898-8439 www.cadth.ca

http://www.cadth.ca/


References

1. Erens GA, Thornhill TS, Katz JN. UpToDate [Internet]. 20.0. 1992 -. Total hip arthroplasty; 2015 Oct 23 [cited 2016 Apr 5]. Available from: www.uptodate.com Subscription required

2. Hip and knee replacements in Canada: Canadian Joint Replacement Registry 2015 annual report [Internet]. Ottawa: Canadian Institute for Health Information; 2015 [cited 2016 Apr 26]. Available from: https://secure.cihi.ca/free_products/CJRR_2015_Annual_Report_EN.pdf

3. DePuy Synthes [Internet]. Warsaw (IN): DePuy Synthes; 2016. Anterior approach for hip arthroplasty; 2015 [cited 2016 Apr 5]. Available from: https://www.depuysynthes.com/providers/improving-performance/anterior-approach

4. Crist BD, Ivie CB, Bal BS. Total hip replacement with use of a direct anterior approach: a critical analysis review. JBJS Reviews. 2014;2(6):e4.

5. Alecci V, Valente M, Crucil M, Minerva M, Pellegrino CM, Sabbadini DD. Comparison of primary total hip replacements performed with a direct anterior approach versus the standard lateral approach: perioperative findings. J Orthop Traumatol [Internet]. 2011 Sep [cited 2016 Apr 5];12(3):123-9. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3163771/pdf/10195_2011_Article_144.pdf

6. Christensen CP, Jacobs CA. Comparison of patient function during the first six weeks after direct anterior or posterior total hip arthroplasty (THA): a randomized study. J Arthroplasty. 2015;30(9 Supplement):94-7.

7. Rodriguez JA, Deshmukh AJ, Rathod PA, Greiz ML, Deshmane PP, Hepinstall MS, et al. Does the direct anterior approach in THA offer faster rehabilitation and comparable safety to the posterior approach? Clin Orthop Relat Res [Internet]. 2014 Feb [cited 2016 Apr 5];472(2):455-63. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3890195/pdf/11999_2013_Article_3231.pdf

8. De Geest T, Fennema P, Lenaerts G, De Loore G. Adverse effects associated with the direct anterior approach for total hip arthroplasty: a Bayesian meta-analysis. Arch Orthop Trauma Surg. 2015 Aug;135(8):1183-92.

9. Lee GC, Marconi D. Complications following direct anterior hip procedures: costs to both patients and surgeons. J Arthroplasty. 2015 Sep;30(9 Suppl):98-101.

10. Shea BJ, Grimshaw JM, Wells GA, Boers M, Andersson N, Hamel C, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Med Res Methodol [Internet]. 2007 [cited 2016 Apr 5];7:10. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1810543/pdf/1471-2288-7-10.pdf

11. Downs SH, Black N. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Community Health [Internet]. 1998 Jun [cited 2016 Apr

https://secure.cihi.ca/free_products/CJRR_2015_Annual_Report_EN.pdfhttps://www.depuysynthes.com/providers/improving-performance/anterior-approachhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3163771/pdf/10195_2011_Article_144.pdfhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3890195/pdf/11999_2013_Article_3231.pdfhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC1810543/pdf/1471-2288-7-10.pdf


5];52(6):377-84. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1756728/pdf/v052p00377.pdf

12. den Hartog YM, Mathijssen NM, Vehmeijer SB. The less invasive anterior approach for total hip arthroplasty: a comparison to other approaches and an evaluation of the learning curve - a systematic review. Hip Int. 2016 Mar 23;26(2):105-20.

13. Yue C, Kang P, Pei F. Comparison of direct anterior and lateral approaches in total hip arthroplasty: a systematic review and meta-analysis (PRISMA). Medicine (Baltimore). 2015 Dec;94(50):e2126.

14. Higgins BT, Barlow DR, Heagerty NE, Lin TJ. Anterior vs. posterior approach for total hip arthroplasty, a systematic review and meta-analysis. J Arthroplasty. 2015 Mar;30(3):419-34.

15. Tsukada S, Wakui M. Lower dislocation rate following total hip arthroplasty via direct anterior approach than via posterior approach: five-year-average follow-up results. Open Orthop J [Internet]. 2015 [cited 2016 Apr 5];9:157-62. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4483535/pdf/TOORTHJ-9-157.pdf

16. Guyatt GH, Haynes RB, Jaeschke RZ, Cook DJ, Green L, Naylor CD, et al. Users' Guides to the medical literature: XXV. Evidence-based medicine: principles for applying the Users' Guides to patient care. Evidence-Based Medicine Working Group. JAMA. 2000 Sep 13;284(10):1290-6.

17. Slavin RE. Best evidence synthesis: an intelligent alternative to meta-analysis. J Clin Epidemiol. 1995 Jan;48(1):9-18.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1756728/pdf/v052p00377.pdfhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4483535/pdf/TOORTHJ-9-157.pdf


Appendix 1: Selection of Included Studies

469 citations excluded

22 potentially relevant articles retrieved for scrutiny (full text, if

available)

2 potentially relevant reports retrieved from other sources (grey

literature, hand search)

24 potentially relevant reports

20 reports excluded: -irrelevant study design (2) -irrelevant intervention (3) -irrelevant comparator (2) -already included in at least one of the selected systematic reviews (13)

4 reports included in review

491 citations identified from electronic literature search and

screened


Appendix 2: Characteristics of Included Publications

Table A1: Characteristics of Included Systematic Reviews and Meta-Analyses

First Author, Publication Year,

Country

Types and numbers of

primary studies included

Population

Characteristics

Intervention and

Comparator(s)

Clinical Outcomes,

Length of Follow-Up

Den Hartog, 201612

The Netherlands

64 included studies:

48 studies comparing DAA vs. PA and/or LA for THA; 2 studies comparing DAA vs.

MP for THA; 14 single group studies (DAA outcomes only).

DAA vs. PA: 23 studies 3 RCTs;

14 NRS (retrospective); 6 NRS (prospective).

DAA vs. LA: 23 studies 5 RCTs; 14 NRS (retrospective);

4 NRS (prospective). DAA vs. PA vs. LA:

2 NRS (retrospective).

Patients of all ages

undergoing primary THA for osteoarthritis.

Comparative studies (DAA vs. PA and/or LA): n = 46,402;

5,538 DAA procedures; 6,596 LA procedures; 34, 268 PA procedures.

Direct anterior approach for

primary THA vs. other surgical approaches for primary THA, including:

Lateral

Mini lateral

Anterolateral

Mini anterolateral

Posterior

Mini posterior

Posterior navigated

Control group (no surgical

intervention).

Surgery time;

Incision length; Blood loss; Complication rate;

Length of hospital stay (LOS); Post-operative pain and pain medication consumption;

Questionnaire scores; Accuracy of component placement checked by post-

operative x-rays; Functional recovery.

Length of follow-up within primary studies: More than 24 mos (2 studies)

12 to 24 mos (13 studies) 6 to12 mos (8 studies) 3 wks to 6 mos (13 studies)

Hospital stay (4 studies) Not reported (8 studies)

Higgins, 201514

United States

17 included studies:

2 RCTs; 10 NRS (retrospective); 5 NRS (prospective).

Patients of all ages

undergoing primary THA.

n = 2,302; 980 DAA procedures; 1,129 PA procedures;

193 control subjects.


primary THA vs. posterior approach for primary THA.

Primary outcome:

Measures of patient-reported pain and function (wide range of validated outcome

measures were eligible) Secondary outcomes:

Intra-operative:

Operative time

Estimated blood loss


Table A1: Characteristics of Included Systematic Reviews and Meta-Analyses First Author,

Publication Year,

Country

Types and numbers of primary studies included

Population Characteristics

Intervention and Comparator(s)

Clinical Outcomes, Length of Follow-Up

Intra-operative fracture Post-operative:

Need for transfusion

Length of hospital stay

Discharge disposition

Rate of dislocation

Narcotic consumption

Gait analysis

Markers of inflammation and muscle damage

Radiographic outcomes:

Percentage of acetabular cups positioned within Lewinnek safe zone

Length of follow-up within primary studies: 12 to 24 mos (6 studies)

3 to 6 mos (5 studies) 3 to 6 wks (3 studies) Hospital stay (3 studies)

Yue, 201513

China

12 included studies: 2 RCTs; 8 NRS (retrospective);

2 NRS (prospective).

Patients of all ages undergoing primary THA.

n = 4,901; 2,991 DAA procedures;

1,910 LA procedures.

Direct anterior approach for primary THA vs. lateral approach for primary THA.

Primary outcomes: Complications; Post-operative function;

Length of stay (LOS). Secondary outcomes:

Radiographic analysis; Transfusions; Pain;

Markers of muscle damage and inflammation;


Table A1: Characteristics of Included Systematic Reviews and Meta-Analyses First Author,

Publication Year,

Country

Types and numbers of primary studies included

Population Characteristics

Intervention and Comparator(s)


Surgery time; Gait.

Length of follow-up within primary studies: More than 36 mos (1 study);

12 to 36 mos (6 studies) 6 wks (1 study); Hospital stay (4 studies).

DAA = direct anterior approach; LA = lateral approach; mos = months; MP = mini-posterior approach; NRS = non-randomized study; PA = posterior approach; RCT = randomized controlled trial; THA = total hip arthroplasty; vs. = versus; wks = w eeks

Table A2: Characteristics of Included Clinical Studies

First Author,

Publication Year, Country, Study

Name

Study Design Patient Characteristics Intervention and Comparator(s)


Tsukada, 201515

Japan

NRS: Retrospective cohort Patients of all ages

undergoing primary THA.

n = 316; 139 DAA procedures; 177 PA procedures.


primary THA vs. posterior approach for primary THA.

Post-operative rate of

dislocation; Implant survival rate with revision surgery;

Complications. Follow-up period (years):

DAA group: 5.3±1.2 PA group: 9.2±2.5

DAA = direct anterior approach; NRS: non-randomized study; PA = posterior approach; THA = total hip arthroplasty; vs. = versus


Appendix 3: Overlap among Studies Included in Systematic Reviews and Meta-Analyses

Table A3. Overlap Among Primary Studies Included in Systematic Reviewsa

Primary Study First Author,

Publication Year

Systematic Review First Author, Publication Year

Den Hartog, 201612

Higgins, 201513

Yue, 201514

Randomized controlled trials

Barrett, 2013

Christensen, 2015

D’Arrigo, 2009

Hozack, 2008

Mayr, 2009

Mjaaland, 2015

Reininga, 2013

Restrepo, 2010

Non-randomized studies (Retrospective)

Abe, 2015

Alecci, 2011

Alexandrov, 2014

Baba, 2014

Berend, 2009

Bhandari, 2009

Bhargava, 2010

Bremer, 2011

Christensen, 2014

De Geest, 2013

Goebel, 2012

Goytia, 2012

Hallert, 2012 Hamilton, 2015

den Hartog, 2015

Jewett, 2011

Ji, 2015

Lamontagne, 2011

Maeda, 2015

Maffiuletti, 2009

Mantovani, 2012

Martin, 2013

Masonis, 2008

Melman, 2015

Mirza, 2014

Morris, 2013

Muller, 2014

Nakata, 2009

Nam, 2013

Oinuma, 2007

Parvizi, 2013

Pogliacomi, 2012a

Pogliacomi, 2012b

Rathod, 2014b

Reichert, 2015

Schweppe, 2013

Sebečić, 2012


Table A3. Overlap Among Primary Studies Included in Systematic Reviewsa

Primary Study First Author,

Publication Year

Systematic Review First Author, Publication Year

Den Hartog, 201612

Higgins, 201513

Yue, 201514

Seng, 2009

Sheth, 2015

Spaans, 2012

Sugano, 2009

Varin, 2013

Wayne, 2009

Woolson, 2009

Yi, 2013

Zawadsky, 2014

Non-randomized studies (Prospective)

Bergin, 2011

Hananouchi, 2009

Ilchmann, 2013

Klausmeier, 2010

Lugade, 2010

Pilot, 2006

Rathod, 2014a

Rodriguez, 2014

Sendtner, 2010

Ward, 2008 aNot all listed studies meet the selection criteria for this report as some systematic reviews used a wider search timeframe and multiple comparators; how ever, all studies focus on patients undergoing THA.


Appendix 4: Critical Appraisal of Included Publications

Table A4: Strengths and Limitations of Systematic Reviews and Meta-Analyses using

AMSTAR10 Strengths Limitations

den Hartog, 201612

Duplicate article screening and data extraction

was performed with a consensus procedure in place in case of disagreements.

A comprehensive search of the literature

(electronic databases) was performed.

A list of included studies and study characteristics was provided.

Methodological quality assessment of included

studies was performed and documented.

The methodological rigor and scientific quality of included studies was considered in the analysis

and conclusions of the review.

Decision to not meta-analyze the results was justified.

Unclear whether the research questions posed

or inclusion criteria used were established a priori (i.e. no evidence of review protocol or pre-defined published research objectives)

Unclear whether the literature search was supplemented by a search for “grey literature”.

List of excluded studies was not provided nor referenced (only reasons for exclusion are

provided).

Quality of included studies was assessed using a non-validated instrument (i.e. eight quality

assessment questions were selected from three previously published instruments).

Results were not presented separately for each

of the considered comparators (i.e. DAA vs. LA and DAA vs. PA).

Likelihood of publication bias was not assessed.

Potential conflicts of interest and sources of

funding of included studies were not described.

Higgins, 201514

Research questions posed and inclusion criteria used were established a priori.

Duplicate article screening and data extraction

was performed with a consensus procedure in place in case of disagreements.

A comprehensive search of the literature (electronic databases) was performed and

supplemented by a search for “grey literature.”


The methodological rigor and scientific quality of included studies was considered in the analysis and conclusions of the review.

Authors’ potential conflicts of interest were clearly acknowledged, and funding sources of included studies were reported.

List of excluded studies was not provided nor referenced (only reasons for exclusion were provided).

Quality of included studies was assessed using a non-validated instrument (i.e. selected elements from three validated quality appraisal

tools).

Methods for statistically combining data from randomized and non-randomized studies were not described, and decision to meta-analyze

studies of different designs was not justified.

Likelihood of publication bias was not formally assessed.

Yue, 201513

Duplicate article screening and data extraction was performed with a consensus procedure in

place in case of disagreements.

A comprehensive search of the literature (electronic databases) was performed.


Methodological quality assessment of included studies was performed and documented.

The methodological rigor and scientific quality of

Unclear whether the research questions posed or inclusion criteria used were established a

priori (i.e. no evidence of review protocol or pre-defined published research objectives)

Literature search was not supplemented by a

search for “grey literature”.

List of excluded studies was not provided nor referenced (only reasons for exclusion are provided).

Methods for statistically combining data from


Table A4: Strengths and Limitations of Systematic Reviews and Meta-Analyses using

AMSTAR10 Strengths Limitations

included studies was considered in the analysis and conclusions of the review.

Authors’ potential conflicts of interest were

clearly acknowledged.

randomized and non-randomized studies were not described, and decision to meta-analyze studies of different designs was not justified.

Likelihood of publication bias was not assessed.

Sources of funding of included studies were not described.

DAA = direct anterior approach; LA = lateral approach; PA = posterior approach; vs. = versus

Table A5: Strengths and Limitations of Non-Randomized Studies using the Downs and Black

Checklist11 Strengths Limitations

Tsukada, 201515

Study objective was clearly described.

Patient characteristics, including selection criteria, were clearly described.

Intervention of interest was described in

sufficient detail.

Adverse events that may have been a consequence of the intervention were measured and reported.

Analysis adjusted for study participants’ different lengths of follow-up.

Study was retrospective.

A non-random, historical cohort was selected as a comparison group, which may introduce a temporal bias and selection bias in the study

population as a result of the difference in the period during which the two surgical approaches were performed.

Unclear whether study subjects were representative of the population from which they were recruited, limiting generalizability.

Unclear whether the treatment staff, setting, and facilities were representative of that in use in the source population.

Procedural integrity or surgeon’s learning curve

was not assessed between groups, which may bias apparent outcome.

Adjustment for confounding was not performed

in the analysis.

No power calculation for determining adequate sample size.


Appendix 5: Main Study Findings and Author’s Conclusions

Table A6: Summary of Findings of Included Studies

Main Study Findings Author’s Conclusions Systematic reviews and meta-analyses

den Hartog, 201612

Number of studies (n) demonstrating strong evidence (≥2 high quality studies and ≥75% studies reported consistent findings) regarding the effectiveness of DAA in comparison with PA or LA, per outcome parameter:

No difference between DAA and LA or PA

In favour of DAA Against DAA

Functional recovery (n = 6)

0 6 0 Need for assistive devices (n = 6)

1 5 0

Number of studies (n) demonstrating conflicting evidence (



Main Study Findings Author’s Conclusions Reduction in surgery time (approximately 30 minutes) and

blood loss over time, following accrued experience.

Number of complications varied between 10 and 200 at the end of the learning curve period (8 studies).

Reduction in surgery time, blood loss, and/or complications was achieved within the first 30-99 cases among 7 studies; number of surgeries defining the learning curve was not specified.

Higgins, 201514

Patient-reported post-operative pain and function (9 studies):

Four studies (using various outcome measures) found

that DAA may provide short-term benefits relating to patient-reported pain and function and favoured this approach over PA; however, no long-term difference

between the DAA and posterior approach was found within these studies for the same outcomes.

Five studies (using various outcomes measures)

found no significant differences in pain and function outcomes between the DAA and posterior approach for THA at any time points.

Secondary outcomes:

No significant difference between groups in terms of estimated blood loss (mL) (7 studies): WMD =

76.02, 95%CI -38.12 to 190.16, P = 0.19.

No significant difference between groups in the rate of intraoperative fractures (7 studies): OR = 1.14,

95%CI = 0.44-2.95, P = 0.79.

No significant difference between groups in terms of operative time (min) (10 studies): WMD = 7.93,

95%CI -1.83 to 17.70, P = 0.11.

There was a significant difference in post-operative hospital length of stay (days) favouring the DAA

group (7 studies): WMD = -0.53, 95%CI -1.01 to -0.04, P = 0.03.

There was a significant difference between groups in the number of postoperative dislocations favouring

the DAA group (7 studies): OR = 0.29, 95%CI = 0.09-0.95, P = 0.04.

No significant difference between groups in the rate of

patients discharged to home versus a rehabilitation facility (5 studies): RR = 1.10, 95%CI = 0.97-1.23, P = 0.13.

No significant difference between groups in the percentage of acetabular cups placed within the Lewinnek safe zone (6 studies): RR = 1.11, 95%CI =

0.99-1.24, P = 0.06.

No significant difference in serum levels of markers of muscle damage and inflammation was found between groups in one study (except increased

creatinine kinase levels in the PA group immediately after THA); another study reported a comparable

“Current evidence comparing outcomes following anterior versus posterior THA does not demonstrate clear superiority of

either approach.” (p.419)

“The anterior approach may provide potential benefits in early patient reported

pain and function outcomes, post-operative length of stay, dislocations and post-operative narcotic consumption.” (p.423)



Main Study Findings Author’s Conclusions amount of inflammation and muscle damage between

groups.

There was a significant difference in post-operative narcotic consumption in favour of DAA immediately

postoperatively (days 0-3) in 2 studies; another study found no significant difference between approaches.

There was no significant difference in spatiotemporal gait analysis between DAA and the posterior

approach following surgery (4 studies).

Yue, 201513

Postoperative function (7 studies):

4 studies showed that DAA led to better functional outcomes, as compared with LA, up to 2 years

following surgery.

3 studies found no significant differences in functional outcomes between DAA and the lateral approach at 1

year (2 studies) or 3.7 years (1 study) after surgery.

Perioperative complications (8 studies):

Both DAA and LA were associated with similar risk of dislocation (RR = 1.15, 95%CI = 0.44-3.04, P = 0.77; 6 studies), intraoperative fracture (RR = 1.53, 95%CI = 0.74-3.16, P = 0.25; 6 studies), nerve palsy (RR =

2.59, 95%CI = 0.70-9.58, P = 0.14; 4 studies), superficial infection (RR = 0.76, 95%CI = 0.22-2.71, P = 0.68; 4 studies), deep infection (RR = 0.70, 95%CI =

0.19-2.53, P = 0.58; 5 studies), and postoperative hematoma (RR = 0.96, 95%CI = 0.32-2.92, P = 0.99; 4 studies).

DAA was associated with higher risk of cutaneous nerve palsy (RR = 5.69, 95%CI = 1.06 – 30.62, P = 0.04)

Hospitalization time/LOS (6 studies):

Hospitalization time after DAA was shorter by a mean

of 1.19 days (95%CI = -2.08 to -0.3, P = 0.009), as compared with the lateral approach.

Secondary outcomes:

Transfusion rates (7 studies) among patients were similar between the DAA and lateral approaches for THA (RR = 0.78, 95%CI =0.60-1.02, P = 0.07).

Surgery time (6 studies) was longer (measured in minutes) with DAA in comparison with the lateral approach (WMD = 7.99, 95%CI = 2.38 – 13.6, P =

0.005).

Radiographic analyses showed that the DAA and lateral approaches were associated with similar

degrees of inclination (WMD = 0.00, 95%CI -1.15 to 1.15, P = 1.00; 5 studies) and anteversion (WMD = 3.05, 95%CI -6.65 to 12.75, P = 0.54; 2 studies), as

well as similar rates of varus or valgus stem

“DAA [for primary THA] may be associated with better early postoperative functional rehabilitation, lower levels of perceived

pain, and shorter hospitalization time. [However], DAA may be associated with longer surgery time.” (p.5)

“[Both THA approaches] appear to be associated with similar rates or perioperative surgical complications and

transfusion, similar results on radiographic and gait analyses, and similar serum levels of inflammation and muscle damage

markers” (p.5)

“The available evidence is still insufficient to conclude whether DAA or the lateral approach is superior for total hip

arthroplasty.” (p.5)



Main Study Findings Author’s Conclusions positioning (RR = 0.92, 95%CI 0.68-1.26, P = 0.62; 4

studies); results were not statistically significant.

Significantly better pain scores after DAA, as comparted with the LA, were reported by four studies,

while two studies found no significant differences in pain scores between groups.

Creatinine kinase levels (marker of muscle damage and inflammation) immediately after THA and four

days postoperatively were significantly higher for the DAA versus LA group, while C-reative protein levels were similar between the two groups (one study).

There was no significant difference in spatiotemporal gait analysis between DAA and the lateral approach following surgery (one study).

Clinical studies

Tsukada, 201515

Postoperative dislocation:

No patients experienced dislocation in the DAA group by the final follow-up.

In the PA group, anterior dislocation occurred in three patients (1.7%) and posterior dislocation in four patients (2.3%). The seven dislocations occurred at 1, 2, 5 weeks, 3 months, 2.5 and 5.2 years after surgery.

The dislocation rate was significantly lower in the DAA group, as compared with the PA group (long-rank P = 0.033; chi-squared P = 0.018)

Implant survival rate with revision surgery:

One patient (0.7%) in the DAA group was revised due

to ceramic linear fracture at 3.8 years after surgery, and six patients (3.4%) in the PA group underwent component revisions due to dislocation (3), deep

infection (2), and ceramic linear fracture.

There was no significant difference in survivorship when revision was used as the end-point (log-rank P = 0.28)

Complications:

There was no significant differences in the overall

complication rate between the two groups (11 of 139 patients (7.9%) in the DAA group versus 23 of 177 patients (13.0%) in the PA group; P = 0.14)

“The dislocation rate of THA via DAA was lower than THA via PA. DAA might be preferable to PA to reduce the [likelihood of]

dislocation [following surgery].” (p.161)

CI = confidence interval; DAA = direct anterior approach; LA = lateral approaches; LOS = length of stay; OR = odds ratio; PA =

posterior approaches; RR = risk ratio; WMD = w eighted mean difference

Context and policy issuesResearch QuestionsKey FindingsMethodsLiterature Search MethodsSelection Criteria and MethodsExclusion CriteriaCritical Appraisal of Individual Studies

Summary of EvidenceQuantity of Research AvailableSummary of Study CharacteristicsSummary of Critical AppraisalSummary of FindingsLimitations

Conclusions and Implications for Decision or Policy MakingReferencesAppendix 1: Selection of Included StudiesAppendix 2: Characteristics of Included PublicationsAppendix 3: Overlap among Studies Included in Systematic Reviews and Meta-AnalysesAppendix 4: Critical Appraisal of Included PublicationsAppendix 5: Main Study Findings and Author’s Conclusions

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