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.

NCT ID: NCT02038686

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Unstable Proximal Femoral Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard PFN-A

Patients with unstable proximal femoral fractures treated with PFN-A short nail (170-240mm)

Group Type: ACTIVE_COMPARATOR

PFN-A

Intervention Type: DEVICE

Long PFN-A

Patients with unstable proximal femoral fractures treated with PFN-A long nail (300-420mm)

Group Type: ACTIVE_COMPARATOR

PFN-A

Intervention Type: DEVICE

Interventions

PFN-A

Intervention Type: DEVICE

Other Intervention Names

Proximal femoral nail Synthes

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc Taulí Hospital Universitari

OTHER

Sponsor Role: collaborator

Ferran Fillat Gomà

OTHER

Sponsor Role: lead

Responsible Party

Ferran Fillat Gomà

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ferran Fillat-Gomà, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Parc Tauli de Sabadell

Joan Murias-Álvarez, MD

Role: STUDY_DIRECTOR

Hospital Universitario Parc Tauli de Sabadell

Locations

Hospital Universitario Parc Taulí de Sabadell

Sabadell, Barcelona, Spain

Countries

Spain

Other Identifiers

CSPTCOT2013/01

Identifier Type: -

Identifier Source: org_study_id