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Stabilization of Fresh Unilateral Unstable Pertrochanteric Hip Fracture

NCT02788994 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-03-22

No results posted yet for this study

Summary

This is a preliminary study to establish the issues and potential of the investigators proposed project, which involves recruitment of patients with and without dementia, who have been admitted to hospital following hip fractures. The study will be evaluating the result of treatment of unstable pertrochanteric hip fractures focusing on how soon mobility is restored leading to their independence. These patients would require surgical fixation (not replacement) of their hip fractures.

The study will evaluate two methods of fixation of hip fractures treated with either a pin (nail) which is inserted within the cavity of the thigh bone or a hip screw with a plate which is applied on the outer aspect of the thigh bone.

The data collected from this study will provide information on whether one method of fixation is better than the other.

Conditions

  • Unilateral Unstable Hip

Interventions

DEVICE

Endovis BA2 nail

The EBA2 intramedullary nailing system is designed for the treatment of lateral proximal femoral fractures, and consists of a standard or medium length nail implantable with the same set of instruments. The system has been designed to allow: * stable fracture synthesis for fast rehabilitation and early mobilization * an efficient set of instruments (only 11) for a swift, reproducible operating technique (just 7 surgical steps)

DEVICE

Dynamic Hip Screw (DHS)

The DHS is designed to provide strong and stable internal fixation of a variety of intertrochanteric, subtrochanteric and basilar neck fractures, with minimal soft tissue irritation. This Dynamic Hip Screw method is currently used and is a one off surgical fixation.

Sponsors & Collaborators

  • Citieffe S.r.l

    collaborator INDUSTRY

  • University of Leeds

    lead OTHER

Principal Investigators

  • Peter Giannoudis, MBBS,CCST,MD · University of Leeds

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-09-30
Completion
2017-12-31

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 NCT02788994 on ClinicalTrials.gov