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A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly: a pilot study for a clinical trial.

ABSTRACT: Introduction:The literature regarding undisplaced femoral neck fractures (FNF) is sparse. The aim of this prospective feasibility study is to compare the clinical outcome after undisplaced FNF treated with internal fixation (IF) and displaced FNF treated with hip arthroplasty. We hypothesized that hip arthroplasty would give a lower incidence of reoperations. Methods:A total of 235 patients were included with a median age of 84 years (range 65-99). A consecutive series of 65 patients with undisplaced FNF were treated with IF, and 170 patients with displaced FNF were treated with either a total hip arthroplasty or a hemiarthroplasty. Follow-up interviews were conducted at 1 year using the Harris Hip Score (HHS), WOMAC, and pain numeric rating scale (PNRS). The minimum follow-up time was 22 months. There was no difference in baseline data between the groups. Results:Nineteen (8%) hips required reoperation at least once at a mean of 6 months (range 0-35). The rate of reoperation was higher in the IF group compared to the hip arthroplasty group (13.8% vs. 5.9%, 95% CI 0.9-6.4). The overall 1-year and 2-year mortality was 28% and 40%, respectively, with no difference between the groups. The most common reasons for reoperations in the IF group were non-union and avascular necrosis, and 6 patients were treated with hip or excision arthroplasty. In the arthroplasty group, the most common indications were deep infection and dislocation. We did not find any differences between the groups in terms of HHS, WOMAC, and PNRS. Conclusions:In this feasibility study, we found no differences in patient-reported outcomes between the groups although IF required a higher rate of reoperations. Further randomized trials are needed to establish the optimal treatment of undisplaced FNF in the elderly. Trial registration:ClinicalTrial.org, NCT03392285. Retrospectively registered on 5 February 2018.

SUBMITTER: Mukka S

PROVIDER: S-EPMC7353692 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly: a pilot study for a clinical trial.

Mukka Sebastian S Sjöholm Pontus P Aziz Athir A Eisler Thomas T Kadum Bakir B Krupic Ferid F Morberg Per P Sayed-Noor Arkan A

Pilot and feasibility studies 20200711

<h4>Introduction</h4>The literature regarding undisplaced femoral neck fractures (FNF) is sparse. The aim of this prospective feasibility study is to compare the clinical outcome after undisplaced FNF treated with internal fixation (IF) and displaced FNF treated with hip arthroplasty. We hypothesized that hip arthroplasty would give a lower incidence of reoperations.<h4>Methods</h4>A total of 235 patients were included with a median age of 84 years (range 65-99). A consecutive series of 65 patie ...[more]

PMID: 32670600

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Project description:INTRODUCTION:Undisplaced femoral neck fractures (FNFs) are usually treated by internal fixation (IF) but two randomised controlled trials (RCTs) have demonstrated advantages of treatment with arthroplasty. The complication rate was lowered but there were no clinically improved patient-reported outcome measures (PROM), which could be due to underpowering or choice of selected PROM as the studies do appear to report a better functional outcome. We will conduct an RCT comparing IF with arthroplasties in patients aged over 65 years with an undisplaced FNF. METHODS AND ANALYSIS:All hospitals in Denmark treating patients with hip fracture can provide patients for this study; therefore, the study can be considered a national RCT. Patients over 65 years old with an undisplaced FNF will be screened for eligibility and patients will only be excluded if they are unable to understand the study information (due to dementia or language), if they have a posterior tilt >20°, a pathological fracture or they cannot walk. Participants will be electronically randomised (in alternating blocks of 4 or 6) into either IF or arthroplasty. Postoperative care will follow the department standards.Primary and secondary outcomes and measuring points have been established in collaboration with patients with hip fracture by focus group interviews. The primary outcome measure is the New Mobility Score assessed after 1?year. Secondary outcomes are the Oxford Hip Score, EuroQol 5 domain (EQ-5D-5L), degree of posterior tilt, pain Verbal Rating Scale, reoperation and mortality. ETHICS AND DISSEMINATION:The study is approved by the Danish Data Protection Agency (19/7429) and the scientific ethics committee (S-20180036). All participants will sign an informed consent before entering the trial. Because this is a national trial, all relevant healthcare professionals in Denmark will automatically receive the trial results that will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Registry (NCT04075461).

Project description:BackgroundCurrently, there are 2 mainstream treatments for displaced femoral neck fracture, including internal fixation and arthroplasty. However, there are still some controversial problems as to which treatment should be primarily chosen.MethodsThe relevant studies comparing arthroplasty with internal fixation were searched in the databases of PubMed, Embase, and Cochrane Library. Finally, 31 relevant randomized controlled trials were included in this meta-analysis. The quality of studies was evaluated and meta-analyses were performed using RevMan 5.3 software. We also assessed the heterogeneity among studies and publication bias via the I-squared index and forest plots.ResultsThere was no significant difference between arthroplasty and internal fixation groups in patient mortality at both short-term and long-term points. However, patients treated with arthroplasty showed significantly lowered risks of reoperation both at short-term (5.6% vs 31.5%; relative risks (RR) = 0.19; 95% CI, 0.13-0.28; P < .00001) and long-term follow-up (9.5% vs 45.9%; RR = 0.23; 95% CI, 0.17-0.33; P < .00001). Similarly, arthroplasty-treated patients demonstrated a significant decrease in the risk of postoperation complications at short-term (10.3% vs 34.4%; RR = 0.37, 95% CI, 0.24-0.57; P < .00001) and long-term follow-up (11.7% vs 42.5%; RR = 0.30, 95% CI, 0.16-0.57; P < .0002). Besides, patients in the arthroplasty group were associated with better alleviation of pain postoperation (18.3% vs 31.1%; RR = 0.50, 95% CI, 0.33-0.78; P = .002).In trial sequence analyses, all cumulative Z curves except that of mortality crossed the trial sequential monitoring boundaries and conventional boundaries, and required information size has been reached.ConclusionsArthroplasty leads to a lower rate of reoperation, a reduced risk of complications, and a better alleviation of postoperation pain both at short-term and long-term follow-up. Most importantly, and according to trial sequence analyses, more than enough evidence has been achieved that arthroplasty does show better outcomes than internal fixation in terms of reoperation rate, complications, and postoperation pain.Level of evidenceTherapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Dataset Information

A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly: a pilot study for a clinical trial.

Publications

A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly: a pilot study for a clinical trial.

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