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Randomized Controlled Trial
. 2023 Jun 1;6(6):e2317164.
doi: 10.1001/jamanetworkopen.2023.17164.

Intramedullary Nailing vs Sliding Hip Screw in Trochanteric Fracture Management: The INSITE Randomized Clinical Trial

Emil H Schemitsch  1   2 , Lauren L Nowak  1   2 , Arndt P Schulz  3 , Ole Brink  4 , Rudolf W Poolman  5 , Samir Mehta  6 , Dirk Stengel  7 , Chang Qing Zhang  8 , Saul Martinez  9 , Bernd Kinner  10 , Timothy J S Chesser  11 , Mohit Bhandari  12 ; INSITE Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Intramedullary Nailing vs Sliding Hip Screw in Trochanteric Fracture Management: The INSITE Randomized Clinical Trial

Emil H Schemitsch et al. JAMA Netw Open. .

Abstract

Importance: Fractures 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.

Objective: To compare 1-year outcomes of patients with trochanteric fractures treated with the IMN vs an SHS.

Design, setting, and participants: This 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.

Interventions: Surgical fixation with a Gamma3 IMN or an SHS.

Main outcomes and measures: The 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).

Results: In 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 relevance: This 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 registration: ClinicalTrials.gov Identifier: NCT01380444.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Schemitsch reported personal fees from Stryker, Smith & Nephew, Amgen, Sanofi, ITS, Depuy-Synthes, Medtronic, Swemac, and Alexion outside the submitted work. Dr Poolman reported grants from ZonMw, LinkLima, Reumafonds, and Achmea outside the submitted work. Dr Mehta reported receipt of institutional grants from the US Department of Defense, AO Foundation, and Orthopaedic Trauma Association; personal fees from Bioventus; and serving as a board member of the AO Foundation and Orthopaedic Trauma Association. Dr Stengel reported receipt of grants from Stryker, Depuy Synthes, ZimmerBiomet, and CeramTec; personal support for attending meetings/travel from CeramTec; and serving on a Data Safety Monitoring Board/Advisory Board for Stryker, DePuy Synthes, ZimmerBiomet, and CeramTec; grants from German Statutory Accident Insurance (DGUV), personal fees from AO Trauma, and personal fees from Ethicon outside the submitted work. Dr Martinez reported grants from Hospital Santa Clara during the conduct of the study; and receipt of institutional grants from Exactech; personal and consulting fees from Exactech; honoraria from Smith & Nephew and Link. Dr Kinner reported receipt of grants and personal fees from Medartis. Dr Chesser reported receipt of personal fees from Stryker for unrelated devices; consulting fees from Stryker and Acumed; and serving as a representative for the Falls and Fragility Fracture Programme (National Hip Fracture Database US) for the British Orthopaedic Association. Dr Bhandari reported receipt of institutional grants from the Canadian Institutes of Health Research, National Institutes of Health, the Michael G. DeGroote Institute for Pain Research and Care and the Physicians’ Services Incorporated Foundation. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Flow Diagram
EQ5D indicates EuroQol–5 Dimension.
Figure 2.
Figure 2.. EuroQol–5 Dimension (EQ5D) Index Scores, Parker Mobility Scores, and Harris Hip Scores Over Time
A, EQ5D index scores were used to measure health-related quality of life, ranging from 0 (death) to 1 (perfect health). B, Parker mobility scores range from 0 to 9, with higher scores indicating more mobility. C, Harris hip scores range from 0 to 100, with higher scores indicating better hip function. Harris hip scores were not measured at baseline.
See this image and copyright information in PMC

Comment in

References

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