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.

Study Overview
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Brief Summary
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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). 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. 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
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Unstable Proximal Femoral Fracture

Intervention / Treatment
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* Device: PFN-A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard PFN-A<br>Patients with unstable proximal femoral fractures treated with PFN-A short nail (170-240mm) | Device: PFN-A<br> <br> * Other names: Proximal femoral nail Synthes;|
| Active Comparator: Long PFN-A<br>Patients with unstable proximal femoral fractures treated with PFN-A long nail (300-420mm) | Device: PFN-A<br> <br> * Other names: Proximal femoral nail Synthes;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip fracture, Unstable (31A2 and 31A3), Proximal femoral nail