Unstable Proximal Femoral Fracture Clinical Trial
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.
n/a