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| Name | Class |
|---|---|
| Synthes Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFNA_Asia treated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFNA-Asia | Device | The operation is performed under regional or general anesthesia and involves the following main steps:
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone/fracture- or implant/surgery-related fracture fixation complication events | 6 and 12 weeks, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mismatch | Perioperatively | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute trochanteric fractures at surgery/ orthopedic departments
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Sawaguchi, MD | Toyama Municipal Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toyama Municipal Hospital | Toyama | 939-8511 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14736471 | Background | Schipper IB, Marti RK, van der Werken C. Unstable trochanteric femoral fractures: extramedullary or intramedullary fixation. Review of literature. Injury. 2004 Feb;35(2):142-51. doi: 10.1016/s0020-1383(03)00287-0. | |
| 7942154 | Background | Nakamura T, Turner CH, Yoshikawa T, Slemenda CW, Peacock M, Burr DB, Mizuno Y, Orimo H, Ouchi Y, Johnston CC Jr. Do variations in hip geometry explain differences in hip fracture risk between Japanese and white Americans? J Bone Miner Res. 1994 Jul;9(7):1071-6. doi: 10.1002/jbmr.5650090715. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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|
| 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 |
| Mortality | 6 and 12 weeks, 6 and 12 months |
| 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 |
| 18582887 | Background | Simmermacher RK, Ljungqvist J, Bail H, Hockertz T, Vochteloo AJ, Ochs U, Werken Cv; AO - PFNA studygroup. The new proximal femoral nail antirotation (PFNA) in daily practice: results of a multicentre clinical study. Injury. 2008 Aug;39(8):932-9. doi: 10.1016/j.injury.2008.02.005. Epub 2008 Jun 25. |
| 10505125 | Background | Simmermacher RK, Bosch AM, Van der Werken C. The AO/ASIF-proximal femoral nail (PFN): a new device for the treatment of unstable proximal femoral fractures. Injury. 1999 Jun;30(5):327-32. doi: 10.1016/s0020-1383(99)00091-1. |
| D007869 |
| Leg Injuries |