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.

Not Applicable

Completed

• Conditions: Unstable Proximal Femoral Fracture
• Interventions: Device: PFN-A

• Registration Number: NCT02038686
• Lead Sponsor: Ferran Fillat Gomà

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-16
• Primary Completion: 2016-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard PFN-A	PFN-A	Patients with unstable proximal femoral fractures treated with PFN-A short nail (170-240mm)
Long PFN-A	PFN-A	Patients with unstable proximal femoral fractures treated with PFN-A long nail (300-420mm)

Primary Outcome Measures

Name	Time	Method
Total number of complications between PFN-A short and PFN-A long	One year	follow-up data is recruited at 4 weeks, 3 months and one

Secondary Outcome Measures

Name	Time	Method
Complete and uneventful radiological and clinical healing of the fracture and mortality	One year	follow-up data is recruited at 4 weeks, 3 months and one year.

Trial Locations

Locations (1)

Hospital Universitario Parc Taulí de Sabadell; 🇪🇸 Sabadell, Barcelona, Spain