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Nail Versus Sliding Hip Screw for Trochanteric Hip Fractures

NCT ID: NCT03172923

Last Updated: 2017-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-08

Study Completion Date

2017-09-01

Brief Summary

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The investigators therefore propose to undertake a further randomised controlled trial comparing the sliding hip screw (SHS) with the Targon PFT intramedullary nail. The aim is to see if the summation of the first trial of 600 participants comparing the sliding hip screw with the Targon PF nails, in conjunction with this study of 400 participants with the updated Targon PFT nail produces results that convincingly demonstrate that this particular design of implant is superior to the sliding hip screw. Because of the financial issues involved a cost benefit comparison for the two procedures is planned at the completion of the study.

Primary outcome measures will be regain of walking ability. Secondary outcome measures recorded with include mortality, length of surgery, operative blood loss, blood transfusion, post-operative complications, hospital stay, need for subsequent revision surgery and degree of residual pain.

Detailed Description

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The trial will be run as close to the ideal trial methodology for a randomised trial as specified by the CONSORT statement as possible. This will include secure randomisation, intention to treat analysis, full reporting of outcomes and follow-up by a person who is blinded to the prosthesis used. The trial will follow the code of good clinical practice as specified by the hospital trusts Research and Development Committee.

In Peterborough all hip fracture patients are admitted to the acute trauma ward and transferred to the care of MJP. Those patients that are willing to participant in one of our randomised trials are consented prior to surgery. Treatment follows standard evidence based protocols with follow-up of all patients in a hip fracture clinic. A comprehensive database is maintained for all patients containing both audit and research data. Included in this is a standardised assessment of outcome.

The sliding hip screw used if of a standard design that has been in use at Peterborough for the last fifty years. The intramedullary nails used will be the Targon PFT nail. This nail is very similar to the Targon PF nail used in the earlier trial on this topic. Bases on the results of the previous study and the experience of other users the nail has undergone minor modifications that are primarily aimed at making the nail easier to use with improved instrumentation and also a change to design of the cross screw aimed at reducing the risk of fracture fixation complications occurring.

Conditions

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Hip Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
outcome assessor is blinded to treatment given

Study Groups

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sliding hip screw

fixation of fracture with a sliding hip screw

Group Type ACTIVE_COMPARATOR

sliding hip screw

Intervention Type DEVICE

fixation of the fracture with a sliding hip screw

intramedullary nail

fixation of the fracture with an intramedullary nail

Group Type EXPERIMENTAL

intramedullary nial

Intervention Type DEVICE

fixation of the fracture with an intramedullary nail

Interventions

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sliding hip screw

fixation of the fracture with a sliding hip screw

Intervention Type DEVICE

intramedullary nial

fixation of the fracture with an intramedullary nail

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients admitted to Peterborough District Hospital with a trochanteric hip fracture that is to be treated by internal fixation.

Exclusion Criteria

* Patients who decline to participate
* Patients without the capacity to give informed consent
* Patients admitted when MJP is not available to supervise treatment
* Patients with pathological fractures from Paget's disease of bone secondaries from tumour
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peterborough and Stamford Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Martyn J Parker

Consultant orthopaedic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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REC 10/H0306/66

Identifier Type: -

Identifier Source: org_study_id