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Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures

NCT02996383 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-12-19

No results posted yet for this study

Summary

In England each year over 70,000 people fracture their hip. Most of these patients are elderly females with the fracture occurring after a simple trip or stumble. Approximately half of these fractures are classified from their relationship to the hip joint capsule as intracapsular. These fractures are subdivided into those that are displaced and those that are undisplaced. The majority of displaced fractures are treated with a replacement arthroplasty. Current treatment for the undisplaced fractures is generally by internal fixation of the fracture using screws and a plate, although some centres prefer replacement arthroplasty.

A recent randomised study on patients from Norway with undisplaced intracapsular fractures treated with either internal fixation or arthroplasty has just reported reduced complications and re-operations for those patients treated with an arthroplasty. In addition functional results were marginally better for those patients treated with an arthroplasty. Current practice in the UK is generally to treat these fractures by internal fixation. This study aims to see if replacement arthroplasty can indeed lead to the advantages suggested from the Norwegian study.

Patients who satisfy the inclusion criteria and are willing to participate will be randomised to receive either reduction and internal fixation of the fracture with a screw and plate device or alternatively replacement of their femoral head with an artificial hip replacement (hemiarthroplasty). After surgery patients will receive the same treatment as normal and be discharge home when able, with follow-up review in the hip fracture clinic. Subsequent follow-up for the research project is by phone calls from a research nurse who is blinded to the type of treatment that the patient has received. There will be no additional investigations or out-patient follow-up visits for these patients in comparison to normal treatment protocols. Results of the study will ultimately be published in a medical journal.

Conditions

  • Hip Fractures
  • Undisplaced Intracapsular Hip Fracture

Interventions

DEVICE

Internal fixation

Internal fixation of the fracture with a Targon FN implant (BBraun Ltd, Germany)

DEVICE

Cemented Hemiarthroplasty

Replacement of the femoral head with a cemented hemiarthroplasty

Sponsors & Collaborators

  • Peterborough and Stamford Hospitals NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02996383 on ClinicalTrials.gov