The primary objective of this prospective multicenter study is to assess any fracture fixation complication and revision rates during the clinical use of the Proximal Femoral Nail Antirotation Asia (PFNA Asia) for the treatment of unstable trochanteric fractures.
From several studies, e.g. on hip prostheses, it is known that the Asian population has other geometric proportions than Caucasians, e.g. Japanese woman have shorter femoral necks, smaller femoral neck angles and a more anterior bowing of the shaft than white Americans. This was one of the reasons for the development of a new PFNA Asia with adapted sizes and geometry. No controlled clinical data are available whether the rate of mismatch and mismatch-related complications could be reduced.
Study Type
OBSERVATIONAL
Enrollment
245
The operation is performed under regional or general anesthesia and involves the following main steps: 1. Positioning of the patient 2. Definition of the CCD-angle 3. Fracture reduction 4. Determination of the nail diameter 5. Incision 6. Insertion of the device
Toyama Municipal Hospital
Toyama, Japan
Bone/fracture- or implant/surgery-related fracture fixation complication events
Time frame: 6 and 12 weeks, 6 and 12 months
Mismatch
Time frame: Perioperatively
Soft tissue/wound -related or general complications
Time frame: 6 and 12 weeks, 6 and 12 months
Health-related quality of life assessed by the generic SF-36-instrument and EQ-5D
Time frame: Baseline, 6 and 12 months
Walking ability (Parker mobility score)
Time frame: Baseline, 6 and 12 months
Range of motion (ROM)
Time frame: 6 and 12 weeks, 6 and 12 months
Mortality
Time frame: 6 and 12 weeks, 6 and 12 months
Surgery details and postoperative treatment
Time frame: till 12 weeks after surgery
Length of hospital stay
Time frame: till 12 weeks after surgery
Capacity to return to pre-residential status
Time frame: 12 weeks
Bone consolidation and anatomical restoration
Time frame: 6 and 12 weeks, 6 and 12 months
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