Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures

NCT ID: NCT02996383

Last Updated: 2016-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31

Brief 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

Keywords

arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cemented hemiarthroplasty

Treatment of the fracture by a replacement arthroplasty with a cemented CPT hemiarthroplasty (manafactured by Zimmer company, Warsaw IN, USA) inserted via an anteriolateral approach to the hip

Group Type: ACTIVE_COMPARATOR

Cemented Hemiarthroplasty

Intervention Type: DEVICE

Replacement of the femoral head with a cemented hemiarthroplasty

Internal fixation

Internal fixation of the fracture with a screw and plate device (Targon FN plate, Aesculap cooperation, Tuttingham, Germany)

Group Type: ACTIVE_COMPARATOR

Internal fixation

Intervention Type: DEVICE

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

Interventions

Internal fixation

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

Intervention Type: DEVICE

Cemented Hemiarthroplasty

Replacement of the femoral head with a cemented hemiarthroplasty

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients admitted to Peterborough and Stamford Hospitals NHS Foundation Trust with an undisplaced intracapsular fracture will be considered for inclusion within the study. Patients who lack Capacity for example dementia who are unable to provide informed consent will be included if the assent of their next of kin or legal guardian can be obtained.

Exclusion Criteria

• • patients who decline to participate or in whom consent or assent is not available

• patients admitted when MJP is not available to supervise treatment
• patients with pathological fractures from Paget's disease of bone secondary's from tumour
• patients with delayed presentation who would be treated conservatively
• patients considered unfit for either surgical procedure
• younger patients, aged less than 80 years who are independently mobile and very active will be excluded at treated by internal fixation (the risk of fracture healing complication for this group is less, whilst there is an increased risk of long term complications after arthroplasty

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peterborough and Stamford Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Martyn J Parker

consultant orthopaedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peterborough and Stamford Hospital NHS Foundation Trust

Peterborough, Cambs, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

martyn parker

Role: CONTACT

Phone: 441733678000

Email: martyn.parker@pbh-tr.nhs.uk

Facility Contacts

Martyn J Parker, MD

Role: primary

Other Identifiers

R&D/2016/05

Identifier Type: -

Identifier Source: org_study_id