Trochanteric Fractures
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPFNA-Asia
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
Sponsors
Synthes Inc.
AO Clinical Investigation and Publishing Documentation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 65 years and older * Patients with isolated, unstable, closed trochanteric fractures, classified as AO 31-A2 or AO 31-A3 * Definitive primary fracture treatment with PFNA Asia within 7 days sustaining the fracture (conversion from an external fixator to the PFNA Asia as an emergency procedure within the first week after the accident is allowed) * Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups * Willing and able to comply with the post-operative management program * Able to understand and read country national language at an elementary level
Exclusion criteria
* Pathologic fracture * Patients or legal guardian refusing to sign the informed consent form * Patients with previous implants on the fractured hip and femur * Drug or alcohol abuse * Active malignancy * ASA class V and VI * Patients who are bed-ridden or wheel-chair ridden prior to injury event * Neurological disorders and psychiatric disorders that would preclude reliable assessment (e.g., Parkinson disease, Multiple sclerosis, severe depression) * Patients who have participated in any other device or drug related clinical trial within the previous month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone/fracture- or implant/surgery-related fracture fixation complication events | 6 and 12 weeks, 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Soft tissue/wound -related or general complications | 6 and 12 weeks, 6 and 12 months |
| Health-related quality of life assessed by the generic SF-36-instrument and EQ-5D | Baseline, 6 and 12 months |
| Walking ability (Parker mobility score) | Baseline, 6 and 12 months |
| Range of motion (ROM) | 6 and 12 weeks, 6 and 12 months |
| Mismatch | Perioperatively |
| Surgery details and postoperative treatment | till 12 weeks after surgery |
| Length of hospital stay | till 12 weeks after surgery |
| Capacity to return to pre-residential status | 12 weeks |
| Bone consolidation and anatomical restoration | 6 and 12 weeks, 6 and 12 months |
| Mortality | 6 and 12 weeks, 6 and 12 months |
Countries
Japan
Outcome results
None listed