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. (PFN-A)

February 1, 2017 updated by: Ferran Fillat Gomà

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitario Parc Tauli de Sabadell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 60 years old above.
  • Patients with trochanteric fracture 31.A2 and 31.A3 AO classification for long bones
  • Patients that accept to participate on the study under consent

Exclusion Criteria:

  • Metaphyseal fractures with extension more than 3 cm in reference to lesser trochanter calibrated and analyzed with PreOPlan registered application.
  • Combination of fractures in the proximal femur.
  • Pathological fractures.
  • Diaphyseal femoral fractures.
  • Rejection of surgery by the patient.
  • Contraindications to the use of either implants studied.
  • Patients who do not wish to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard PFN-A
Patients with unstable proximal femoral fractures treated with PFN-A short nail (170-240mm)
Device: PFN-A
Other Names:
  • Proximal femoral nail Synthes
Active Comparator: Long PFN-A
Patients with unstable proximal femoral fractures treated with PFN-A long nail (300-420mm)
Device: PFN-A
Other Names:
  • Proximal femoral nail Synthes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of complications between PFN-A short and PFN-A long
Time Frame: One year
follow-up data is recruited at 4 weeks, 3 months and one
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete and uneventful radiological and clinical healing of the fracture and mortality
Time Frame: One year
follow-up data is recruited at 4 weeks, 3 months and one year.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferran Fillat Gomà

Collaborators

Hospital Parc Taulí, Sabadell

Investigators

  • Study Director: Joan Murias-Álvarez, MD, Hospital Universitario Parc Tauli de Sabadell

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPTCOT2013/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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