Clinical Trial: Intracapsular Femoral Neck Fractures Fixation With a Dynamic Locking Plate and Screw System, Targon FN
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Intracapsular Femoral Neck Fractures Fixation With a Dynamic Locking Plate and Screw System, Targon FN. Prospective and Retrospective Cohort Study.
Brief Summary: The purpose of this study is to evaluate our experience in internal fixation of intracapsular femoral neck fractures with the Targon FN implant prospectively and retrospectively in terms of the outcomes and complications associated with the treatment.
Detailed Summary:
Intracapsular femoral neck fractures include subcapital and transcervical fractures. They typically occur in a bimodal age distribution, with most occurring in the elderly population. The rest are the result of high energy injury in the young. Management of those fractures is based on few factors related to the patient, such as preinjury ambulatory status, age, cognitive function, and co morbidities, and on factors related to the fracture like the type of the fracture and the degree of displacement. Treatment options include nonsurgical management, fixation (percoutan, CRIF, ORIF) or arthroplasty (hemiarthroplasty, THR). Undisplaced hip fractures are defined as fractures where the inferior cortical buttress is undisplaced on the anteroposterior (AP) radiograph.[1] Undisplaced hip fractures includes fractures impacted in all degrees of valgus regardless of any angulations at the fractures' edges seen on the lateral radiographs. The fractures can be classified using either the Garden or Pauwel classifications for subcapital fracture or transcervical fractures, respectively. In displaced intracapsular femoral neck fractures like Garden type 3 and 4 or in unstable transcervcal fractures like Pauwel type 3 which are subjected to increased shear loads [2], the goals, for a physiologically young and active adult, are to preserve the femoral head, avoid osteonecrosis, and achieve union in order to avoid arthroplasty. Femoral neck fractures in young adults are associated with higher incidences of femoral head osteonecrosis [3-11] and nonunion [3, 4, 7, 12]. The reported rate of osteonecrosis after a femoral neck fracture in young patients ranges from 12% to 86% [3, 6-15]. This complication may lead to collapse of the femoral head and osteoarthritis. Salvage procedures, such as osteotomy, and other reoperations have high failure rates, and arthroplasty procedures are not ideal, given the patient's young age and higher level of act
Sponsor: Sheba Medical Center
Current Primary Outcome: overall survival, fixation survival and a composite end-point combining the two [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome: length of surgery, bleeding, ambulation [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Sheba Medical Center
Dates:
Date Received: January 25, 2009
Date Started: January 2009
Date Completion: January 2012
Last Updated: September 5, 2010
Last Verified: September 2010
