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Treatment of Unstable 31.A2 and 31.A3 Trochanteric Fractures. Randomised Comparison of the Proximal Femoral Nail PFN-A Short and the PFN-A Long.

NCT02038686 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2017-02-02

No results posted yet for this study

Summary

1. Introduction:

Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an intramedullary short PFN-A or long PFN-A. A prospective, randomized, controlled trial is performed to compare the outcome treatment of these unstable fractures of the proximal part of the femur with either a short PFN-A (170-240mm) or long PFN-A (300-420mm).
2. Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer complications than Long PFN-A

Main Objective: Is defined as Total number of complications between PFN-A short and PFN-A long. Outcome measures were subdivided into preoperative, perioperative and post-operative. Follow up data at four weeks, three months and one year.

Secondary objectives: Complete and uneventful radiological and clinical healing of the fracture. Revision operations (related to the failure of primary treatment) and mortality. Baseline characteristics were documented pre-operatively: Outcome measures were subdivided into intra-operative, post-operative and follow up data at four weeks, three months and one year.
3. Methodology: One hundred and eighty eight patients presenting with an AO/OTA 31-A2 and 31-A3 fracture of the proximal part of the femur will be randomized, at the time of the admission, to fixation with use either a short PFN-A or a long PFN-A.

Conditions

  • Unstable Proximal Femoral Fracture

Interventions

DEVICE

PFN-A

Sponsors & Collaborators

  • Parc Taulí Hospital Universitari

    collaborator OTHER

  • Ferran Fillat Gomà

    lead OTHER

Principal Investigators

  • Ferran Fillat-Gomà, MD · Hospital Universitario Parc Tauli de Sabadell

  • Joan Murias-Álvarez, MD · Hospital Universitario Parc Tauli de Sabadell

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-31
Completion
2017-01-31

Countries

  • Spain

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 NCT02038686 on ClinicalTrials.gov