NCT03065101

Trigen InterTAN vs Sliding Hip Screw RCT

Functional Advantages of TRIGEN™ INTERTAN™ Over Sliding Hip Screw in Subjects With Trochanteric Hip Fracture: A Randomised Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hip Fractures

Interventions

Type	Name	Description
DEVICE	Trigen Intertan	While both the Trigen InterTAN and Sliding Hip Screw are marketed and demonstrated to be suitable for treatment of the study indication, the randomisation is considered an intervention as it may be contrary to the treatment chosen by the surgeon were the patient not a study subject.
OTHER	Post-Surgery Follow Up	The current clinical trend is for minimal follow up post-surgery, unless indicated by complications. The study protocol indicated that follow up telephone visits are to be performed at 8 weeks, 12 weeks and 12 months post-surgery and an outpatient follow up visit at 6 months post-surgery. While most outcome measures are conducted via questionnaire, the increase in follow up means that subjects may be exposed to increased ionising radiation.
DEVICE	Sliding Hip Screw	Sliding Hip Screw

Timeline

• Start date: 2017-09-30
• Primary completion: 2017-09-30
• Completion: 2017-09-30
• First posted: 2017-02-27
• Last updated: 2019-03-29

Locations

5 sites across 1 country: United Kingdom