Intramedullary Nail versus Sliding hip screw Inter-Trochanteric Evaluation (INSITE): a multicenter randomized controlled trial
- Conditions
- S72.1Pertrochanteric fracture
- Registration Number
- DRKS00003342
- Lead Sponsor
- Stryker Osteosynthesis Clinical Research
- Brief Summary
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 (ß [SE] , 0.01 [0.05]; P = .82) or previous fracture (ß [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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 850
trochanteric fracture necessitation surgical intervention
surgical intervention first 7 days after trauma
informed consent by patient or guardian
1. Associated major injuries of the lower extremity
2. Retained hardware around the affected proximal femur.
3. Infection around the proximal femur
4. Patients with disorders of bone metabolism other than osteoporosis
5. Patients with a pathologic fracture.
6. Patients with a fracture AO Type 31-A3.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Health related Quality of life assessed with the Euroquol 5D after 1 year
- Secondary Outcome Measures
Name Time Method a) Revision surgery rates at 1 Mo./ 4 Mo./ 12 Mo.<br>b) Fracture healing rates at 1 yr.<br>c) Fracture-related adverse events at 1 Mo./ 4 Mo./ 12 Mo.<br>d) Health-related quality of life (HRQL), including the Parker mobility score (Mobility) at 1 Mo./ 4 Mo./ 12 Mo. and Harris Hip Score (Hip Function) at 1 Mo./ 4 Mo./ 12 Mo.