Intramedullary Nailing vs Sliding Hip Screw in Trochanteric Fracture Management

Author:

Schemitsch Emil H.12,Nowak Lauren L.12,Schulz Arndt P.3,Brink Ole4,Poolman Rudolf W.5,Mehta Samir6,Stengel Dirk7,Zhang Chang Qing8,Martinez Saul9,Kinner Bernd10,Chesser Timothy J.S.11,Bhandari Mohit12,Garcia Julio C.13,Ramokgopa Mmampapatla13,Probe Robert13,Hymes Robert13,Marcantonio Andrew13,Rehman Saqib13,Rodriguez Edward13,Morshed Saam13,Baysal Deniz13,Hall Jeremy13,Tufescu Ted13,Bucknill Andrew13,Ichimura Hrumitsu13,Punsvik Vidar13,McAndrew Andrew13,Datta Goray13,Kumar Gunasekaran13,Zhou Junlin13,Feng Gang13,

Affiliation:

1. London Health Sciences Centre, London, Ontario, Canada

2. Western University, London, Ontario, Canada

3. University Hospital Lubeck, Lubeck, Germany

4. Aarhus University, Aarhus, Denmark

5. Leiden University, Leiden, the Netherlands

6. University of Pennsylvania, Philadelphia

7. BG Kliniken: Klinikverbund der gesetzlichen Unfallversicherung gGmbH, Berlin, Germany

8. Shanghai Jiao Tong University, Shanghai, China

9. Hospital Santa Clara, Bogotá, Colombia

10. Robert-Bosch Krankenhaus, Stuttgart, Germany

11. North Bristol National Health Service (NHS) Trust, Bristol, United Kingdom

12. McMaster University, Hamilton, Ontario, Canada

13. for the INSITE Investigators

Abstract

ImportanceFractures of the hip have devastating effects on function and quality of life. Intramedullary nails (IMN) are the dominant implant choice for the treatment of trochanteric fractures of the hip. Higher costs of IMNs and inconclusive benefit in comparison with sliding hip screws (SHSs) convey the need for definitive evidence.ObjectiveTo compare 1-year outcomes of patients with trochanteric fractures treated with the IMN vs an SHS.Design, Setting, and ParticipantsThis randomized clinical trial was conducted at 25 international sites across 12 countries. Participants included ambulatory patients aged 18 years and older with low-energy trochanteric (AO Foundation and Orthopaedic Trauma Association [AO/OTA] type 31-A1 or 31-A2) fractures. Patient recruitment occurred between January 2012 and January 2016, and patients were followed up for 52 weeks (primary end point). Follow-up was completed in January 2017. The analysis was performed in July 2018 and confirmed in January 2022.InterventionsSurgical fixation with a Gamma3 IMN or an SHS.Main Outcomes and MeasuresThe primary outcome was health-related quality of life (HRQOL), measured by the EuroQol–5 Dimension (EQ5D) at 1-year postsurgery. Secondary outcomes included revision surgical procedure, fracture healing, adverse events, patient mobility (measured by the Parker mobility score), and hip function (measured by the Harris hip score).ResultsIn this randomized clinical trial, 850 patients were randomized (mean [range] age, 78.5 [18-102] years; 549 [64.6% female) with trochanteric fractures to undergo fixation with either the IMN (n = 423) or an SHS (n = 427). A total of 621 patients completed follow-up at 1 year postsurgery (304 treated with the IMN [71.9%], 317 treated with an SHS [74.2%]). There were no significant differences between groups in EQ5D scores (mean difference, 0.02 points; 95% CI, −0.03 to 0.07 points; P = .42). Furthermore, after adjusting for relevant covariables, there were no between-group differences in EQ5D scores (regression coefficient, 0.00; 95% CI, −0.04 to 0.05; P = .81). There were no between-group differences for any secondary outcomes. There were also no significant interactions for fracture stability (β [SE] , 0.01 [0.05]; P = .82) or previous fracture (β [SE], 0.01 [0.10]; P = .88) and treatment group.Conclusions and RelevanceThis randomized clinical trial found that IMNs for the treatment of trochanteric fractures had similar 1-year outcomes compared with SHSs. These results suggest that the SHS is an acceptable lower-cost alternative for trochanteric fractures of the hip.Trial RegistrationClinicalTrials.gov Identifier: NCT01380444

Publisher

American Medical Association (AMA)

Subject

General Medicine

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