Bone&JointOutcome. The TRIGEN INTERTAN Intertrochanteric Antegrade Nail. Our Products in Clinical Studies

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1 Our Products in Clinical Studies Vol 04, No 01 July 2017 The TRIGEN INTERTAN Intertrochanteric Antegrade Nail A Systematic Literature Review and Meta-analysis of Clinical Outcomes Compared to Standard of Care in the Treatment of Intertrochanteric Hip Fractures

2 Authors: Leo Nherera¹, Catherine Dunbar², Jonathan Ridgway¹, Alan Horner¹ 1 Smith & Nephew, Hull, UK 2 Smith & Nephew, Baar, Switzerland Table of Contents REFERENCES APPENDIX REVIEW DISCUSSION RESULTS METHODS BACKGROUND OVERVIEW Overview 3 Background 4 Methods 5 Results 7 Conclusions 13 Review 14 Appendix 15 References 17 Page 2

3 Overview The TRIGEN INTERTAN Intertrochanteric Antegrade Nail: A Systematic Literature Review and Meta-analysis of Clinical Outcomes Compared to Standard of Care in the Treatment of Intertrochanteric Hip Fractures OVERVIEW Purpose of review To evaluate and summarize the current evidence on the clinical performance of the TRIGEN INTERTAN (Smith & Nephew, Memphis, TN, USA) integrated two-screw cephalomedullary nail compared to other devices used as standard of care in the treatment of intertrochanteric hip fractures. Standard care for intertrochanteric fractures is either the use of extrameduallary implants such as a sliding hip screw or an intramedullary nail, depending upon the fracture sub-type 1. Background Since its introduction in 2006, several studies have reported on the performance of TRIGEN INTERTAN nail. To obtain a more thorough understanding of this device s performance, we conducted a systematic review of the literature to collect data from comparative studies reporting: implant-related failures; non-union rates; revision or reoperation rates; and/or patient functional status measures. Evidence Type of evidence Study characteristics Number of studies: 10 Mean follow-up: 15.3 months Mean age: TRIGEN INTERTAN = 78.3 Comparators = 77.8 years Mean sample size: TRIGEN INTERTAN = 95 Comparators = 104 Number of hips in study: 1,994 Study designs included: RCTs; Retrospective comparative Key results and considerations A systematic literature review and meta-analysis of the literature found that, compared to those treated with comparator devices the TRIGEN INTERTAN nail results in: Design rationale Economic analysis Pre-clinical study Registry data Clinical study Literature review A 69% reduction in implant failures (p=0.001) A 73% reduction in non-unions (p=0.01) A 54% reduction in patients complaining of hip and thigh pain (p=0.003) Improvement in health related quality of life, as measured by the SF-36 (physical health) score, in a single study (p=0.002) Level of evidence I II III IV Level of evidence rating 6 4 Number of clinical studies (Total = 10) Appendix: An additional analysis In addition to the systematic literature review and meta-analysis, a review of time to union data in further publications found: A faster time to fracture union with the TRIGEN INTERTAN nail: 14.1 weeks vs 16.9 weeks for comparator devices (see appendix) Page 3

4 Background Since its introduction in 2006, several studies have reported on the performance of the TRIGEN INTERTAN nail (Figure 1). To obtain a more thorough understanding of this device s performance, we conducted a systematic review of the literature to collect data from comparative studies reporting: implant-related failures; non-union rates; revision or reoperation rates; and/or patient functional status measures. BACKGROUND Figure 1: TRIGEN INTERTAN Page 4

5 Methods A comprehensive systematic literature review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines 2. Eligibility criteria The eligibility criteria for the systematic literature review are outlined below. Inclusion criteria: 1. Full-text peer-reviewed articles reporting the outcomes of clinical studies 2. Articles in English 3. Randomized controlled trials (RCTs) or comparative studies where the TRIGEN INTERTAN nail was a test group 4. Device used to treat extracapsular hip fractures Exclusion criteria: 1. Meta-analyses or systematic reviews of the TRIGEN INTERTAN nail performance 2. Studies where the TRIGEN INTERTAN nail was not a test group 3. Observational studies of the TRIGEN INTERTAN nail without direct comparison to other fixation devices 4. Device used in intracapsular or femoral neck hip fractures 5. Material-, biomechanical-, or cadaveric-testing studies 6. Comparison studies of the TRIGEN INTERTAN nail with arthroplasty 7. Not published in English Literature search A thorough and systematic literature search was conducted using the EMBASE and PubMed databases. An additional hand search was performed with the Google Scholar database, utilizing the same search terms, to identify any articles missed in the EMBASE or PubMed searches. The searches were run to include citations from 2005 to January The search strategy is outlined in Figure 2. Our initial search identified 233 items. Upon application of the inclusion/exclusion criteria, 224 did not meet the eligibility criteria for this review. The reasons for their ineligibility are provided in Figure 2. One additional article was identified through the hand search in Google Scholar. Therefore, ten articles were included in the current analysis METHODS Figure 2: Literature Review 233 Studies identified EMBASE: 135 PubMed: 98 Title/Abstract review Full text review Hand search with Google Scholar: 10 Articles included in review Excluded Studies Met one or more of the exclusion criteria outlined above -45 Excluded Studies Met one or more of the exclusion criteria: 20 Duplicates: 25 Page 5

6 Methods Cont. Data abstraction Data were abstracted from the ten included comparative studies on the TRIGEN INTERTAN nail. All studies reported on one or more of the following endpoints, and as outlined in Table 1: Implant-related failure, including post-operative fracture, cut-out and/or collapse Non-union rates Revision or reoperation rates Patient functional status measures, including hip and thigh pain and/or Short Form 36 health survey questionnaire (SF 36) Statistical analyses The outcomes for the TRIGEN INTERTAN nail were compared to the outcomes for the other standard of care (comparator) devices using the Review Manager (RevMan 5) software, a validated meta-analysis tool from Cochrane 13. A standard pairwise meta-analysis was conducted using either a fixed-effect model where there was no evidence of significant heterogeneity between studies (I 2 statistic less than 50%), or a random-effects model when heterogeneity was likely (I 2 statistic more than 50%). For dichotomous outcomes, odds ratio (OR) was reported as the summary statistic, and for continuous outcomes, the (weighted) mean difference (MD) was reported. METHODS Implant-related failure was reported in all ten studies. Nonunion rate was reported in three studies. Revision or reoperation rates were provided in eight studies. Patient functional status measures were reported in seven studies, including hip and thigh pain in six and SF 36 in one. See Table 1 for the outcomes reported in each study Table 1: Outcomes reported in each study Study Implant-related failure Non-union rate Revision or reoperation rate Patient functional status measures Hip and thigh pain SF 36 Berger-Groch, 2016 Matre, 2013 Sanders, 2017 Seyhan, 2015 Su, 2016 Wang, 2014 Wu, 2014 Yu, 2016 Zehir, 2015 Zhang, 2013 Page 6

7 Results Study characteristics In total, 1,994 patients were included from the ten studies: 952 for the TRIGEN INTERTAN nail group and 1,042 for the comparators, which included Sliding Hip Screws (SHS) (Compression Hip Screw, Smith & Nephew, Memphis, TN, USA; Dynamic Hip Screw [DHS] Synthes, Basel, Switzerland), Proximal Femoral Nail Antirotation (PFNA/PFNA-II, Synthes, Basel, Switzerand), and Gamma 3 nails (Stryker, Mahwah, NJ, USA). Study characteristics are summarized in Figure 3. More detail on the study characteristics can be found in Table 2 on page 14. Figure 3: Study characteristics Number of studies: 10 Study designs included: Mean follow-up: RCTs; Retrospective comparative 15.3 months RESULTS Mean age (years): TRIGEN INTERTAN = 78.3 Comparators = 77.8 Mean sample size: TRIGEN INTERTAN = 95 Comparators = 104 Total number of hips 1,994 Page 7

8 Results Cont. Implant-related failures The endpoints of post-operative fracture, cut-out and collapse were combined to measure implant-related failures. There was a statistically significant 69% reduction in implant-related failures with the TRIGEN INTERTAN nail versus comparator devices (p = 0.001), which included Gamma 3, SHS, PFNA and PFNA-II (39/933 implant-related failures for TRIGEN INTERTAN vs 116/1004 for comparators): Results support: Lower risk of implant failure Odds Ratio 0.31 (95% CI ). Implant-related failures for each study in the analysis and the Odds Ratio are shown in Figure 4. Figure 4: Forest Plot for Implant-related failures, TRIGEN INTERTAN versus all comparators Study, year Total number patients (INTERTAN) Total number implant-related failures (INTERTAN) Total number patients (comparators) Total number implant-related failures (comparators) RESULTS Weight OR [95% confidence interval] OR [95% confidence interval] Randomized controlled trials Berger-Groch, % Matre, % Sanders, % Seyhan, % Su, % Zhang, % Subtotal % Heterogeneity: Tau² = 0.11; Chi² = 6.03, df = 5 (P = 0.30); I² = 17% Test for overall effect: Z = 1.54 (P = 0.12) 0.89 [0.05, 14.60] 0.66 [0.33, 1.33] 1.03 [0.46, 2.31] 0.26 [0.01, 5.51] 0.17 [0.02, 1.55] 0.06 [0.00, 1.00] 0.61 [0.33, 1.14] Retrospective comparative studies Wang, % Wu, % Yu, % Zehir, % Subtotal % Heterogeneity: Tau² = 0.00; Chi² = 2.54, df = 3 (P = 0.47); I² = 0% Test for overall effect: Z = 4.95 (P < ) 0.38 [0.07, 2.08] 0.13 [0.03, 0.58] 0.17 [0.07, 0.46] 0.03 [0.00, 0.52] 0.17 [0.08, 0.34] Total % Heterogeneity: Tau² = 0.54; Chi² = 19.04, df = 9 (P = 0.02); I² = 53% Test for overall effect: Z = 3.30 (P = 0.001) Test for subgroup differences: Chi² = 7.28, df = 1 (P = 0.007); I² = 86.3% 0.31* [0.15, 0.62] *An Odds Ratio of 0.31 is equivalent to a 69% reduction in implant-related failures with TRIGEN INTERTAN Favors INTERTAN Favors comparators Page 8

9 Results Cont. Non-union There was a statistically significant 73% reduction in nonunions with the TRIGEN INTERTAN nail versus comparator devices, (p=0.01) which included Gamma 3, SHS and PFNA-II (4/462 non-unions for TRIGEN INTERTAN vs 18/535 for comparators): Odds Ratio 0.27 (95% CI ). Results support: Lower risk of non-union Non-union events for each study included in the analysis and the Odds Ratio are shown in Figure 5. Figure 5: Forest Plot for Non-unions, TRIGEN INTERTAN versus all comparators Study, year Total number patients (INTERTAN) Total number non-unions (INTERTAN) Total number patients (comparators) Total number non-unions (comparators) Weight OR [95% confidence interval] OR [95% confidence interval] RESULTS Randomized controlled trials Matre, % Zhang, % Subtotal % Heterogeneity: Chi² = 0.21, df = 1 (P = 0.64); I² = 0% Test for overall effect: Z = 2.34 (P = 0.02) 0.28 [ ] 0.13 [0.01, 2.61] 0.24 [0.07, 0.79] Retrospective comparative studies Wu, % Subtotal % Heterogeneity: Not applicable Test for overall effect: Z = 0.85 (P = 0.40) 0.39 [0.05, 3.42] 0.39 [0.05, 3.42] Total % Heterogeneity: Chi² = 0.34, df = 2 (P = 0.84); I² = 0% Test for overall effect: Z = 2.45 (P = 0.01) Test for subgroup differences: Chi² = 0.15, df = 1 (P = 0.75), I² = 0% 0.27* [0.10, 0.77] *An Odds Ratio of 0.27 is equivalent to a 73% reduction in non-unions with TRIGEN INTERTAN Favors INTERTAN Favors comparators Page 9

10 Results Cont. Revisions or re-operation rates There was a 10% reduction in revision in favour of the TRIGEN INTERTAN nail versus all comparators, which included Gamma 3, SHS, PFNA and PFNA-II (53/789 revisions for TRIGEN INTERTAN vs 59/851 for comparators), although this difference was not significant (p=0.60): Odds ratio 0.90 (95% CI ). One study reported this outcome but there were no revisions in either study arm and hence it was not included in the statistical analysis. 5 Revision events for each study included in the analysis and the Odds Ratio are shown in Figure 6. Figure 6: Forest Plot for Revision surgery, TRIGEN INTERTAN versus all comparators Study, year Total number patients (INTERTAN) Total number revisions (INTERTAN) Total number patients (comparators) Total number revisions (comparators) RESULTS Weight OR [95% confidence interval] OR [95% confidence interval] Randomized controlled trials Berger-Groch, % Matre, % Sanders, % Su, % Zhang, % Subtotal % Heterogeneity: Chi² = 3.81, df = 4 (P = 0.43); I² = 0% Test for overall effect: Z = 0.02 (P = 0.98) 1.81 [0.16, 20.62] 1.00 [0.57, 1.73] 1.54 [0.63, 3.74] 0.17 [0.02, 1.55] 0.64 [0.10, 4.00] 1.00 [0.65, 1.53] Retrospective comparative studies Wu, % Zehir, % Subtotal % Heterogeneity: Chi² = 0.21, df = 1 (P = 0.65); I² = 0% Test for overall effect: Z = 1.14 (P = 0.25) 0.80 [0.15, 4.18] 0.50 [0.16, 1.54] 0.58 [0.23, 1.48] Total % Heterogeneity: Chi² = 5.20, df = 6 (P = 0.52); I² = 0% Test for overall effect: Z = 0.52 (P = 0.60) Test for subgroup differences: Chi² = 1.06, df = 1 (P = 0.30); I²= 6.1% 0.90* [0.61, 1.33] *An Odds Ratio of 0.90 is equivalent to a 10% reduction in revisions in favor of TRIGEN INTERTAN Favors INTERTAN Favors comparators Page 10

11 Results Cont. Patient functional status measures Hip and thigh pain There was a statistically significant 54% reduction in patients reporting chronic hip and thigh pain with the TRIGEN INTERTAN nail versus comparator devices (p=0.003), which included Gamma 3, PFNA and PFNA-II (25/390 reporting hip and thigh pain for TRIGEN INTERTAN vs 53/476 for comparators): Odds Ratio 0.46 (95% CI ). Results support: Reduced postoperative pain Hip and thigh pain cases for each study included in the analysis and the Odds Ratio are shown in Figure 7. Figure 7: Forest Plot of Hip and thigh pain analysis, TRIGEN INTERTAN versus comparators Study, year Total number of patients (INTERTAN) Randomized controlled trials Total number of cases of hip and thigh pain (INTERTAN) Total number of patients (comparators) Total number of cases of hip and thigh pain (comparators) Weight OR [95% confidence interval] OR [95% confidence interval] RESULTS Seyhan, % Su, % Zhang, % Subtotal % Heterogeneity: Chi² = 1.66, df = 2 (P = 0.44); I² = 0% Test for overall effect: Z = 2.02 (P = 0.04) 1.35 [0.08, 22.51] 0.70 [0.15, 3.31] 0.27 [0.09, 0.83] 0.42 [0.18, 0.97] Retrospective comparative studies Wu, % Yu, % Zehir, % Subtotal % Heterogeneity: Chi² = 2.44, df = 2 (P = 0.30); I² = 18% Test for overall effect: Z = 2.24 (P = 0.02) 1.15 [0.33, 4.04] 0.33 [0.13, 0.86] 0.44 [0.15, 1.35] 0.49 [0.26, 0.91] Total % Heterogeneity: Chi² = 4.18, df = 5 (P = 0.52); I² = 0% Test for overall effect: Z = 3.00 (P = 0.003) Test for subgroup differences: Chi² = 0.09, df = 1 (P = 0.77), I²= 0% 0.46* [0.28, 0.77] *An Odds Ratio of 0.46 is equivalent to a 54% reduction in hip and thigh pain with TRIGEN INTERTAN Favors INTERTAN Favors comparators Page 11

12 Results Cont. SF-36 scores One study reported on SF-36. This showed a statistically significant higher SF-36 (physical health) score in favor of the TRIGEN INTERTAN nail versus the comparator (Gamma 3) (p=0.002). Results support: Proven high return to pre-fracture status Figure 8: SF-36 (physical health) analysis, TRIGEN INTERTAN versus comparator RESULTS Study, year Total number patients (INTERTAN) Mean SF-36 score (INTERTAN) [Standard deviation] Total number patients (comparators) Mean SF-36 score (comparators) [Standard deviation] Berger-Groch, [13.1] [11.2] 100% Total [13.1] [11.2] 100% Heterogeneity: Not applicable Test for overall effect: Z = 3.10 (P = 0.002) Weight Mean difference [95% confidence interval] 7.40 [2.73,12.07] 7.40* [2.73,12.07] *A positive mean difference favors the test group (TRIGEN INTERTAN), and appears on the right side of the chart Mean difference [95% confidence interval] Favors comparator Favors INTERTAN RESULTS Page 12

13 Conclusions Compared to those treated with standard care, TRIGEN INTERTAN results in: A statistically significant 69% reduction in implant-related failures (p=0.001) A statistically significant 73% reduction in non-unions (p=0.01) A 10% reduction in revisions, which was not statistically significant (p=0.60) A statistically significant 54% reduction in patients reporting chronic hip and thigh pain (p=0.003) A statistically significant higher SF-36 (physical health) score, in a single study (p=0.002) CONCLUSIONS Page 13

14 Review of study characteristics Table 2: Study characteristics breakdown Study, year Level I: RCTs Level II: Prospective comparative Level III: Retrospective, comparative Level IV: Case series Sample size, hips; (IT vs comparator) Mean age, years (Standard deviation) % Male Length of follow up, months % Loss to follow up at final follow up Berger-Groch, (IT =55; Gamma 3 = 49) IT = 81.6 (+/-9.4) Gamma 3 = 82.0 (+/-9.2) IT = 21.8 Gamma 3 = (with assessments at 1.5, 3 and 6) Total = 68.3 (60.6 died, 7.7 lost) Matre, (IT = 334; SHS = 338) IT = 84.1 SHS = 84.1 IT = 22.8 SHS = IT = 41.0 (25.1 died; 15.9 lost) SHS = 41.7 (25.7 died; 16.0 lost) Sanders, (IT = 123; SHS = 126) IT = 80.6 (+/-0.8) SHS = 81 (+/-0.8) IT = 29.3 SHS = IT = 17.1 SHS = 28.3 Seyhan, (IT = 32; PFNA = 43) IT = 75.3 (+/-13.52) PFNA =75.9 (+/ IT = 25.0 PFNA = $ Total = 17.3 Su, (IT = 50; Gamma 3 = 50) IT = 70.1 (+/-9.2) Gamma 3 = 71.3 (+/-8.7) IT = 42.0 Gamma 3 = IT = 6.0 Gamma 3 = 10.0 Zhang, (IT = 57; PFNA-II = 56) IT = 72.9 (+/-7.6) PFNA-II = 72.4 (+/-8.7) IT = 40.4 PFNA-II = IT = 17.5 (14.0 died, 3.5 lost) PFNA-II = 17.9 (12.5 died, 5.4 lost) REVIEW Wang, (IT =37; DHS = 38) IT = 61 (22-91) ; DHS = 57 (20-85) ) IT = 48.6 DHS = (+/-5.6)* IT = 16.2 DHS = 21.1 Wu, (IT = 87; Gamma 3 = 174) IT = 71.4 (+/-9.7) Gamma 3 = 72.6 (+/-8.6) IT = 23.0 Gamma 3 = IT = 0 Gamma 3 = 0 Yu, enrolled 147 available for analysis IT =75 PFNA-II =72 IT = 75.2 (+/-8.8) PFNA-II = 74.2 (+/-9.1) IT = 46.6 PFNA-II = Total = 13.7 (4.8 died, 4.8 too infirmed, 4.2 lost) Zehir, (IT = 102; PFNA = 96) IT = 76.9 (+/-6.7) PFNA = 77.2 (+/-6.8) IT = 38.2 PFNA = 38.5 IT = 16.0 (1-40) PFNA = 16.1 (1-46) # N/A Key: IT = TRIGEN INTERTAN; N/A = not applicable; $ = Final follow up; = Range; * = Mean follow up (Standard deviation); # = Median follow up (Range) Page 14

15 Appendix: An Additional Analysis of Time to Union Data Background The original systematic literature review (as outlined in the main document) focused only on comparative clinical studies of the TRIGEN INTERTAN nail. In this review, three randomized controlled studies reporting mean time to union data were identified. The small total patient number and heterogeneity in follow-up times in these studies meant that the data were fragile and a meta-analysis could not be conducted. Therefore, we also reviewed non-comparative studies to evaluate additional evidence concerning the performance of the TRIGEN INTERTAN nail, where sufficient comparative data did not exist. Methods Literature search: Additional review of non-comparative studies Three RCTs reported mean time to union: two comparing the TRIGEN INTERTAN nail to PFNA 6,12 and one to SHS 8. The small total patient number and heterogeneity in follow-up times meant that the data were fragile, and hence there was a need to expand the search criteria. Therefore, we also included noncomparative, single-arm, case series reporting on the performance of the TRIGEN INTERTAN nail for this endpoint. The additional articles were identified with the same search terms using databases as described in the main systematic review (see page 5): however, the inclusion criteria were expanded to include single-arm case series. To ensure completeness, we also sought expert opinion to ensure we did not miss any publications from the systematic search. Two non-comparative studies were identified reporting mean time to fracture union for the TRIGEN INTERTAN nail 14, 15. In order to find mean time to union rates for comparator devices, a published systematic review 16 from 2016 was used to identify appropriate publications. From this, six studies were identified. Data abstraction As well as the three comparative studies 6,8,12 reporting mean time to fracture union, data were collated for the TRIGEN INTERTAN nail from the two identified non-comparative studies. 14, 15 Time to fracture union rates for comparator devices were collated from the three comparative studies 6,8,12 and the further six identified non-comparative studies Statistical analyses A meta-analysis could not be conducted for the time to fracture union endpoint due to fragility of data caused by the heterogeneity in follow-up times and low total patient number. Instead, non-comparative studies were included and a nonstatistically validated method was used to generate the mean time to fracture union for the TRIGEN INTERTAN nail corrected for population size, to minimize bias resulting from small studies. Here, the time to union was multiplied by the number of patients for each study: the results for each study were added and then divided by the pooled patient number. For comparator devices, time to fracture union rates were extracted from the studies identified and a mean of these results was calculated, also corrected for population size. APPENDIX Page 15

16 Appendix: An Additional Analysis of Time to Union Data Cont. Results Study characteristics For the non-comparative studies reporting on time to fracture union for the TRIGEN INTERTAN nail, 152 patients were included from two studies (in addition to the 110 patients from comparative studies). For the non-comparative studies reporting on time to fracture union for comparator devices, 1,216 patients were included from six studies (in addition to the 119 patients from comparative studies). Time to fracture union Mean time to fracture union was 14.1 weeks for TRIGEN INTERTAN versus 16.9 weeks for all comparators, which included SHS, PFNA and PFNA-II. Conclusion Compared to those treated with standard care, the TRIGEN INTERTAN nail results in a nearly three week faster time to fracture union. Further comparative studies are needed to strengthen the data on time to union and enable a future metaanalysis to be conducted on this outcome. Results support: Faster time to fracture union Table 3: Time to fracture union rates Study, year Level I: RCTs Level II: Prospective comparative Level III: Retrospective, comparative Level IV: Case series Time to fracture union [weeks (range)] TRIGEN INTERTAN Time to fracture union [weeks (range)] All comparators Seyhan, (+/-3.86)*, 32 patients 9.79 (+/-2.22)*, 43 patients Wang, (+/-1.8)*, 31 patients 13.1 (+/-2.8)*, 30 patient Zhang, (+/-4.86)*, 47 patients 17.0 (+/-4.37)*, 46 patients Wu, (+/- 4.4)*, 80 patients Kim, (6-24), 72 patients. Tao, ( ), 45 patients APPENDIX Huang, 2012 Sahin, (12-52), 13 patients ( ), 47 patients Hsueh, (15-24), 937 patients Liu, 2010 Riha, (12-25), 143 patients 10.0 (6-16), 31 patients APPENDIX Mean time to fracture union * Standard deviation Page 16

17 References 1. National Institute for Health and Care Excellence (NICE). Hip fracture: management. Clinical guideline (Last updated 2017). Available at: org.uk/guidance/cg Shamseer L, Moher D, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015;349:g Berger-Groch J, Rupprecht M, Schoepper S, Schroeder M, Rueger JM, Hoffmann M. Five-Year Outcome Analysis of Intertrochanteric Femur Fractures: A Prospective Randomized Trial Comparing a 2-Screw and a Single-Screw Cephalomedullary Nail. J Orthop Trauma. 2016;30: Matre K, Vinje T, Havelin LI, et al. TRIGEN INTERTAN intramedullary nail versus sliding hip screw:a prospective, randomized multicenter study on pain, function, and complications in 684 patients with an intertrochanteric or subtrochanteric fracture and one year of follow-up. J Bone Joint Surg Am. 2013;95: Sanders D, Bryant D, Tieszer C, et al. A Multicenter Randomized Control Trial Comparing a Novel Intramedullary Device (InterTAN) Versus Conventional Treatment (Sliding Hip Screw) of Geriatric Hip Fractures. J Orthop Trauma. 2017;31: Seyhan M, Turkmen I, Unay K, Ozkut AT. Do PFNA devices and Intertan nails both have the same effects in the treatment of trochanteric fractures? A prospective clinical study. J Orthop Sci. 2015;20: Nyholm AM, Palm H, Malchau H, Troelsen A, Gromov K. Lacking evidence for performance of implants used for proximal femoral fractures - A systematic review. Injury. 2016;47: Liu Y, Tao R, Liu F, et al. Mid-term outcomes after intramedullary fixation of peritrochanteric femoral fractures using the new proximal femoral nail antirotation (PFNA). Injury. 2010;41: Sahin EK, Imerci A, Kinik H, Karapinar L, Canbek U, Savran A. Comparison of proximal femoral nail antirotation (PFNA) with AO dynamic condylar screws (DCS) for the treatment for unstable peritrochanteric femoral fractures. Eur J Orthop Surg Traumatol. 2014;24: Hsueh K, Fang C. Risk factors in cutout of sliding hip screw in intertrochanteric fractures: an evaluation of 937 patients. Int Orthop. 2010;34: Huang FT, Lin KC, Yang SW, Renn JH. Comparative study of the proximal femoral nail antirotation versus the reconstruction nail in the treatment of comminuted proximal femoral fracture. Orthopedics. 2012;35:e Riha D, Bartoni cek J. Internal fixation of pertrochanteric fractures using DHS with a two-hole side-plate. Int Orthop. 2010;34: Tao R, Lu Y, Xu H, Zhou ZY, Wang YH, Liu F. Internal fixation of intertrochanteric hip fractures: a clinical comparison of two implant designs. Sci World J. 2013;2013: Su H, Sun K, Wang X. A randomized prospective comparison of Intertan and Gamma3 for treating unstable intertrochanteric fractures. Int J Clin Exp Med. 2016;9: Wang Q, Yang X, He HZ, Dong LJ, Huang DG. Comparative study of InterTAN and Dynamic Hip Screw in treatment of femoral intertrochanteric injury and wound. Int J Clin Exp Med. 2014;7: 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;9: Yu W, Zhang X, Zhu X, Hu J, Liu Y. A retrospective analysis of the InterTan nail and proximal femoral nail anti-rotation-asia in the treatment of unstable intertrochanteric femur fractures in the elderly. J Orthop Surg Res. 2016;11: Zehir S, Sahin E, Zehir R. Comparison of clinical outcomes with three different intramedullary nailing devices in the treatment of unstable trochanteric fractures. Ulus Travma Acil Cerrahi Derg, 2015;21(6: Zhang S, Zhang K, Jia Y, Yu B, Feng W. InterTan nail versus Proximal Femoral Nail Antirotation-Asia in the treatment of unstable trochanteric fractures. Orthopedics. 2013;36:e Cochrane. RevMan 5 (2014). Available at: review-production-tools/revman-5. Accessed November 30, Kim JW, Kim TY, Ha YC, Lee YK, Koo KH. Outcome of intertrochanteric fractures treated by intramedullary nail with two integrated lag screws: A study in Asian population. Indian J Orthop. 2015;49: Wu Y, Watson JT, Kuldjanov D, Jackman J. Rotationally stable fixation for intertrochanteric hip fractures: the Intertan experience, surgical technique, and outcomes. Techniques in Ortho. 2014;29;3: REFERENCES Page 17

18 Notes Page 18

19 Notes Page 19

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