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.

Ferran Fillat Gomà

Status: Completed

Conditions: Unstable Proximal Femoral Fracture

Treatments: Device: PFN-A

Study type: Interventional

Funder types: Other

Identifiers

NCT02038686

CSPTCOT2013/01

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Standard PFN-A

Active Comparator group

Description:

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

Treatment:

Device: PFN-A

Long PFN-A

Active Comparator group

Description:

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

Treatment:

Device: PFN-A