Trigen InterTAN vs Sliding Hip Screw RCT

Status Terminated

Clinical Trial Summary

The purpose of this study is to compare the Trigen InterTAN Intramedullary nail to Sliding Hip Screws in AO/OTA 31-A1 and A2 intertrochanteric hip fractures.

Clinical Trial Description

A multicentre, randomised controlled trial, conducted in the UK will recruit 180 subjects, randomised to receive either the Trigen InterTAN Nail or the Sliding Hip Screw.

Subjects presenting at participating hospitals with AO/OTA 31-A1 or A2 fractures will be assessed against the eligibility criteria and approached for Informed Consent.

Subjects who are considered eligible and who have provided Informed Consent will be randomised using iDataFax to one of the two treatment options.

Subjects will be operated on according to standard procedure and the Instructions for Use.

A daily inpatient assessment will record the subjects use of opioid pain medication.

Subjects will be assessed at the time of discharge to record their residential and ambulatory status, Functional Independence Measure, Get Up and Go Test and opioid usage.

At 8 weeks and 12 weeks post surgery, subjects will be contacted by telephone to confirm their residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.

At 6 months post surgery, subjects will attend an outpatient visit to have a follow up radiograph, Get Up and Go Test, residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.

At 12 months post surgery, subjects will be contacted by telephone to confirm their residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.

Adverse events, device deficiencies and reoperations will be recorded as and when they occur throughout the study. ;

Study Design

Related Conditions & MeSH terms

Hip Fractures

Clinical Trial Details

NCT number	NCT03065101
Study type	Interventional
Source	Smith & Nephew, Inc.
Contact
Status	Terminated
Phase	N/A
Start date	September 30, 2017
Completion date	September 30, 2017

View Details

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