Short Versus Standard Intramedullary Nail for Trochanteric Hip Fractures

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

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-06-30

Brief Summary

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In England each year over 65,000 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 extracapsular. The majority of these fractures are treated surgically by internal fixation using, either a plate and screws (sliding hip screw) or nail and screws (intramedullary nail).

Recent randomised studies from Peterborough involving 1000 patients have indicated that there are modest benefits for treating this type of fracture with an intramedullary nail in comparison to a sliding hip screw. This study aims to progress from these earlier studies to determine if a slightly thinner and shorter intramedullary nail (175mm in length), has any significant advantages or disadvantages to the standard length (220mm) intramedullary nail.

Both implants to be used in this study are in routine use around the world and are being used within their licenced indication. The study is therefore using two different designs of implant within their recommended area of use, but in which there is uncertainty as to which is the best design.

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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 clinical 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 the Chief Investigator (Mr Martyn Parker (MJP)). Those patients that are willing to participant in this randomised trial 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.

Conditions

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Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard length intramedullary nail

220mm intramedullary nail

Group Type ACTIVE_COMPARATOR

targon pft nail

Intervention Type DEVICE

220 mm vs 175mm nail

Short length intramedullary nail

175mm intramedullary nail

Group Type EXPERIMENTAL

targon pft nail

Intervention Type DEVICE

220 mm vs 175mm nail

Interventions

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targon pft nail

220 mm vs 175mm nail

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients admitted to Peterborough City Hospital with a trochanteric hip fracture (type A1 type A2) that is to be treated by internal fixation with an intramedullary nail.

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 secondaries from tumour
* Patients with a Subtrochanteric fracture and those of the reversed and transverse fracture type (A3 fractures)

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No