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Randomized Controlled Trial
. 2025 Oct 9;35(1):425.
doi: 10.1007/s00590-025-04552-6.

Patient and surgical factors affecting recovery after femur fracture fixation: a secondary analysis of the FLiP trial

Marc Gonsalves  1 , Daniel E Axelrod  2 , Ernesto Guerra-Farfan  3 , Yaiza Garcia-Sanchez  3 , Brad Meulenkamp  4 , Melanie Dodd-Moher  5 , Sofia Bzovsky  1 , Christy Shibu  1 , Gina Del Fabbro  1 , Jodi L Gallant  1 , Thomas Mammen  6 , Herman Johal  1 , Sheila Sprague  1   7
Affiliations
Randomized Controlled Trial

Patient and surgical factors affecting recovery after femur fracture fixation: a secondary analysis of the FLiP trial

Marc Gonsalves et al. Eur J Orthop Surg Traumatol. .

Erratum in

Abstract

Purpose: Despite optimal surgical intervention, patients with femoral shaft fractures often report functional limitations, pain, and an overall reduction in their quality of life. The clinical objective of the FLiP pilot trial was to determine whether patient positioning during femur fixation influences postoperative femoral alignment and associated health outcomes. This secondary analysis aimed to identify demographic and surgical factors associated with health-related quality of life and functional outcomes in FLiP trial participants using data from the EuroQol-5 Dimensions 5-Level (EQ-5D-5L) visual analog scale (VAS), EQ-5D-5L Function, and modified Harris Hip Score (mHHS).

Methods: We conducted three linear repeated measure mixed models to determine factors associated with the EuroQol-5 Dimensions (EQ-5D-5L) visual analog scale (VAS), EQ-5D-5L Function, and modified Harris Hip Score (mHHS) over 6-week, 3-month, and 6-month postoperative fixation. Results were presented as adjusted mean differences (AMDs), 95% confidence intervals (CIs), and p-values.

Results: A total of 96 participants were included in this secondary analysis. The mean age was 61.8 years (SD 26.1), and 51 (53.1%) participants were female. Most participants had a proximal third diaphysis fracture (65.3%), followed by a mid-diaphyseal fracture (33.7%), and a distal third diaphysis fracture (1.0%), with subtrochanteric fractures present in 59 (61.5%) participants. A higher Injury Severity Score (ISS) was associated with a lower EQ-5D-5L VAS score (AMD -0.78, 95% CI -1.44 to -0.11; p = 0.04), indicating a worse health status. Open fractures (n = 3) were associated with lower EQ-5D-5L Function scores compared to closed fractures (AMD -0.26, 95% CI -0.45 to -0.067; p = 0.01), indicating worse function. No factors were found to be significantly associated with mHHS.

Conclusions: These results highlight the importance of injury severity within the context of patient health-related quality of life and demonstrate that regardless of the quality of fracture fixation, participants may experience a slower recovery due to sustaining multiple injuries. These findings offer valuable prognostic information for surgeons to share with patients who have more severe injuries.

Trial registration: ClinicalTrials.gov NCT0386280.

Keywords: Femoral shaft fracture; Function; Health-related quality of life; Lateral positioning; Supine positioning.

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Conflict of interest statement

Declarations. Conflict of interest: SS reports Geistlich Pharma AG: Paid consultant; McMaster University: Employee, outside the submitted work. BM reports Bioventus: Paid consultant; Smith and Nephew: Paid consultant, outside the submitted work. HJ reports DePuy, A Johnson and Johnson Company: Paid presenter or speaker; Orthopaedic Research Society: Board or committee member; Stryker: Paid presenter or speaker, outside the submitted work. All other authors have nothing to disclose.

References

    1. Denisiuk M, Afsari A. Femoral Shaft Fractures. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 [cited 2025 Mar 5]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK556057/
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    1. Axelrod D, Johal H, Madden K, Marcano F, Prada C (2019) Fracture table vs. lateral positioning for intramedullary fixation of femur fractures (the FLiP study): a protocol for a pilot randomized controlled trial. PeerJ Prepr 7:e27875v2
    1. FLiP Investigators. Fracture Table vs. Lateral Positioning for Intramedullary Fixation of Femur Fractures (The FLiP Study): The Feasibility of a Cluster Randomized Crossover Study. Pilot Feasibility Stud. Submitted Apr 2024.
    1. FLiP Investigators. Fracture Table vs. Lateral Positioning for Intramedullary Fixation of Femur Fractures (The FLiP Study): The Clinical Outcomes of a Multi-Centre Cluster Randomized Crossover Pilot Study. J Orthop Trauma. Submitted Jan 2025

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