Dataset Information

Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial.

ABSTRACT:

Objective

To compare the functional results after displaced fractures of the femoral neck treated with internal fixation or hemiarthroplasty.

Design

Randomised trial with blinding of assessments of functional results.

Setting

University hospital.

Participants

222 patients; 165 (74%) women, mean age 83 years. Inclusion criteria were age above 60, ability to walk before the fracture, and no major hip pathology, regardless of cognitive function.

Interventions

Closed reduction and two parallel screws (112 patients) and bipolar cemented hemiarthroplasty (110 patients). Follow-up at 4, 12, and 24 months.

Main outcome measures

Hip function (Harris hip score), health related quality of life (Eq-5d), activities of daily living (Barthel index). In all cases high scores indicate better function.

Results

Mean Harris hip score in the hemiarthroplasty group was 8.2 points higher (95% confidence interval 2.8 to 13.5 points, P=0.003) at four months and 6.7 points (1.5 to 11.9 points, P=0.01) higher at 12 months. Mean Eq-5d index score at 24 months was 0.13 higher in the hemiarthroplasty group (0.01 to 0.25, P=0.03). The Eq-5d visual analogue scale was 8.7 points higher in the hemiarthroplasty group after 4 months (1.9 to 15.6, P=0.01). After 12 and 24 months the percentage scoring 95 or 100 on the Barthel index was higher in the hemiarthroplasty group (relative risk 0.67, 0.47 to 0.95, P=0.02. and 0.63, 0.42 to 0.94, P=0.02, respectively). Complications occurred in 56 (50%) patients in the internal fixation group and 16 (15%) in the hemiarthroplasty group (3.44, 2.11 to 5.60, P<0.001). In each group 39 patients (35%) died within 24 months (0.98, 0.69 to 1.40, P=0.92)

Conclusions

Hemiarthroplasty is associated with better functional outcome than internal fixation in treatment of displaced fractures of the femoral neck in elderly patients.

Trial registration

NCT00464230.

SUBMITTER: Frihagen F

PROVIDER: S-EPMC2137068 | biostudies-literature | 2007 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial.

Frihagen Frede F Nordsletten Lars L Madsen Jan Erik JE

BMJ (Clinical research ed.) 20071204 7632

<h4>Objective</h4>To compare the functional results after displaced fractures of the femoral neck treated with internal fixation or hemiarthroplasty.<h4>Design</h4>Randomised trial with blinding of assessments of functional results.<h4>Setting</h4>University hospital.<h4>Participants</h4>222 patients; 165 (74%) women, mean age 83 years. Inclusion criteria were age above 60, ability to walk before the fracture, and no major hip pathology, regardless of cognitive function.<h4>Interventions</h4>Clo ...[more]

PMID: 18056740

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Project description:IntroductionHip fracture is a serious injury in adults, especially those aged over 60 years. The most common type of hip fracture (displaced intracapsular) is treated for the majority of patients with a partial hip replacement (hemiarthroplasty). The hemiarthroplasty implant can be fixed to the bone with or without bone cement. Cement is the current recommended technique but recently some risks have been identified, which could potentially be avoided by using uncemented implants. Controversy, therefore, remains about which type of hemiarthroplasty offers patients the best outcomes.This is the protocol for a multicentre randomised controlled trial comparing cemented hemiarthroplasty versus uncemented hemiarthroplasty for patients 60 years and over with a displaced intracapsular hip fracture.Methods and analysisMulticentre (a minimum of seven UK hospitals), multisurgeon, parallel group, two-arm, superiority, randomised controlled trial. Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible. Participants will be randomly allocated on a 1:1 basis to either a cemented hemiarthroplasty or a modern hydroxyapatite coated uncemented hemiarthroplasty. Otherwise all care will be in accordance with the National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in the primary endpoint: health-related quality of life (EuroQol 5 dimensions 5 levels) at 4 months postinjury. The treatment effect will be estimated using a two-sided t-test adjusted for age, gender and cognitive impairment based on an intention-to-treat analysis. Secondary outcomes include mortality, complications including revision surgery and cause, mobility status, residential status, health-related quality of life at 1 and 12 months and health resource use. A within-trial economic analysis will be conducted.Ethics, dissemination and fundingWales Research Ethics Committee 5 approved the feasibility phase on 2 December 2016 (16/WA/0351) and the definitive trial on 22 November 2017 (17/WA/0383). This study is sponsored by the University of Oxford and funded by the National Institute for Health Research, Research for Patient Benefit (PB-PG-0215-36043 and PB-PG-1216-20021). A manuscript for a peer-reviewed journal will be prepared and the results shared with patients via local mechanisms at participating centres.Trial registration numberISRCTN18393176.

Project description:BackgroundThe choice of primary hemiarthroplasty or total hip arthroplasty in patients ≥80 years of age with a displaced femoral neck fracture has not been adequately studied. As the number of healthy, elderly patients ≥80 years of age is continually increasing, optimizing treatments for improving outcomes and reducing the need for secondary surgery is an important consideration. The aim of the present study was to compare the results of hemiarthroplasty with those of total hip arthroplasty in patients ≥80 years of age.MethodsThis prospective, randomized, single-blinded trial included 120 patients with a mean age of 86 years (range, 80 to 94 years) who had sustained an acute displaced femoral neck fracture <36 hours previously. The patients were randomized to treatment with hemiarthroplasty (n = 60) or total hip arthroplasty (n = 60). The primary end points were hip function and health-related quality of life at 2 years. Secondary end points included hip-related complications and reoperations, mortality, pain in the involved hip, activities of daily living, surgical time, blood loss, and general complications. The patients were reviewed at 3 months and 1 and 2 years.ResultsWe found no differences between the groups in terms of hip function, health-related quality of life, hip-related complications and reoperations, activities of daily living, or pain in the involved hip. Hip function, activities of daily living, and pain in the involved hip deteriorated in both groups compared with pre-fracture values. The ability to regain previous walking function was similar in both groups.ConclusionsWe found no difference in outcomes after treatment with either hemiarthroplasty or total hip arthroplasty in active octogenarians and nonagenarians with a displaced femoral neck fracture up to 2 years after surgery. Hemiarthroplasty is a suitable procedure in the short term for this group of patients.Level of evidenceTherapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Project description:BackgroundOf all distal radius fractures, 25 % are complete articular fractures (AO/OTA type C fractures). Two thirds of those fractures are displaced and require reduction. According to several International Guidelines, adequately reduced intra-articular distal radius fractures are best treated non-operatively with plaster immobilisation, while surgical fixation is suggested only when the articular step exceeds 2 mm after reduction. However, these recommendations are based on studies that did not differentiate between intra- and extra-articular distal radius fractures. Thus, no clear consensus about the best treatment for patients with displaced intra-articular distal radius fractures can be reached. Despite the lack of evidence, an increase in internal fixation of intra-articular distal radius fractures has been observed over the last decade. The aim of this study is to determine the difference in functional outcome following open reduction and plate fixation compared with non-operative treatment with closed reduction and plaster immobilisation in patients with a displaced intra articular distal radius fracture.Methods/designThis multicentre randomised controlled trial will randomise between open reduction and internal plate fixation (intervention group) and closed reduction and plaster immobilisation (control group). All consecutive adult patients from 18 to 65 years with a displaced intra-articular distal radius fracture (AO/OTA type C), which has been adequately reduced at the Emergency Department according to the Dutch National Guidelines, are eligible for inclusion in this study. The primary outcome is function and pain of the wrist assessed with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes are the Disability of the Arm, Shoulder and Hand score (DASH), pain, quality of life (SF-36), range of motion, grip strength, radiological parameters, complications, crossovers and cost-effectiveness of both treatments. A total of 90 patients will be included in this study.DiscussionAlthough displaced intra-articular distal radius fractures are common, there is still no evidence on the optimal treatment for these fractures in patients aged 18 to 65 years. Therefore we aim to determine the difference in functional outcome between open reduction and plate fixation and closed reduction and plaster immobilisation.Trial registrationThis study is registered at ClinicalTrials.gov ( NCT02651779 ) on January 4(th) 2016.

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

Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial.

Objective

Design

Setting

Participants

Interventions

Main outcome measures

Results

Conclusions

Trial registration

Publications

Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial.

Similar Datasets

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