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Trigen InterTAN vs Sliding Hip Screw RCT

NCT03065101 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-03-29

No results posted yet for this study

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.

Conditions

  • Hip Fractures

Interventions

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

Sponsors & Collaborators

  • Smith & Nephew Orthopaedics AG

    lead INDUSTRY

Principal Investigators

  • Stephen Mitchell, MBChB FRCS · University Hospitals Bristol and Weston NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03065101 on ClinicalTrials.gov