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HOPE-trial: hemiarthroplasty compared to total hip arthroplasty for displaced femoral neck fractures in the elderly-elderly, a randomized controlled trial.

ABSTRACT: A femoral neck fracture (FNF) is a common cause of suffering and premature death in the elderly population. Optimizing the treatment for improved outcome and a reduced need for secondary surgery is important both for the patient and the society. The choice of primary total or hemiarthroplasty in patients over eighty years are controversial. We hypothesized that total hip arthroplasty has an equal or better outcome in patient-reported outcome compared with hemiarthroplasty.A prospective, randomized, single-blinded trial will be conducted. We will include 120 patients, 80 years of age and over with an acute (<36 h) displaced femoral neck fracture. The patients will be randomized in a 1:1 ratio to either total hip arthroplasty or hemiarthroplasty. The primary endpoints are Harris hip Score and EQ-5D. Secondary endpoints include pain measured with visual analogue scale, surgical time, reoperations, complications and radiological measurement of erosion in patients operated with hemiarthroplasty. Follow-up will be performed postoperatively after three months, 1, 2, 4 and 10 years.To our knowledge, this is the first randomized controlled trial comparing total hip arthroplasty and hemiarthroplasty for displaced femoral neck fracture in patients age 80 years and over.Clinicaltrial.gov: NCT02246335.

SUBMITTER: Skoldenberg O

PROVIDER: S-EPMC4617887 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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HOPE-trial: hemiarthroplasty compared to total hip arthroplasty for displaced femoral neck fractures in the elderly-elderly, a randomized controlled trial.

Sköldenberg Olof O Chammout Ghazi G Mukka Sebastian S Muren Olle O Nåsell Hans H Hedbeck Carl-Johan CJ Salemyr Mats M

BMC musculoskeletal disorders 20151019

<h4>Background</h4>A femoral neck fracture (FNF) is a common cause of suffering and premature death in the elderly population. Optimizing the treatment for improved outcome and a reduced need for secondary surgery is important both for the patient and the society. The choice of primary total or hemiarthroplasty in patients over eighty years are controversial. We hypothesized that total hip arthroplasty has an equal or better outcome in patient-reported outcome compared with hemiarthroplasty.<h4> ...[more]

PMID: 26480938

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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:BackgroundRandomized controlled trials (RCTs) are the most reliable way of evaluating the effect of new treatments by comparing them with previously accepted treatment regimens. The results obtained from an RCT are extrapolated from the study environment to the general health care system. The ability to do so is called external validity. We sought to evaluate the external validity of an RCT comparing the results of total hip arthroplasty with those of hemiarthroplasty for the treatment of displaced femoral neck fractures in patients ≥80 years of age.MethodsThis prospective, single-center cohort study included 183 patients ≥80 years of age who had a displaced femoral neck fracture. All patients were screened according to the inclusion and exclusion criteria for an RCT comparing total hip arthroplasty and hemiarthroplasty. The population for this study consisted of patients who gave their informed consent and were randomized into the RCT (consenting group, 120 patients) as well as those who declined to give their consent to participate (non-consenting group, 63 patients). The outcome measurements were mortality, complications, and patient-reported outcome measures. Follow-up was carried out postoperatively with use of a mailed survey that included patient-reported outcome questionnaires.ResultsWe found a statistically significant and clinically relevant difference between the groups, with the non-consenting group having a higher risk of death compared with the consenting group. (hazard ratio, 4.6; 95% confidence interval, 1.9 to 11.1). No differences were found between the groups in terms of patient-reported outcome measures or surgical complications.ConclusionsThis cohort study indicates a higher mortality rate but comparable hip function and quality of life among eligible non-consenters as compared with eligible consenters when evaluating the external validity of an RCT in patients ≥80 years of age with femoral neck fracture.Level of evidenceTherapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Dataset Information

HOPE-trial: hemiarthroplasty compared to total hip arthroplasty for displaced femoral neck fractures in the elderly-elderly, a randomized controlled trial.

Publications

HOPE-trial: hemiarthroplasty compared to total hip arthroplasty for displaced femoral neck fractures in the elderly-elderly, a randomized controlled trial.

Similar Datasets

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