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| Name | Class |
|---|---|
| Synthes Inc. | INDUSTRY |
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In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. Due to the play between screw and nail, the reduction can be lost and the instability can result in malunions, nonunions, or pseudoarthrosis. Consequently, secondary angular fracture dislocation (defined as a difference of the angle of 10° or more from the post-operative to the follow-up x-rays) can be observed in approximately 30% of patients after conventional intramedullary nailing of proximal third tibial fractures and in approximately 0-2% in patients with distal third tibial fractures. Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to reduce the risk of secondary loss of reduction by providing axial and angular stability. ASLS provides angular stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes.
The present study evaluates the handling of ASLS and the surgeon's compliance as well as any complications occurring during the baseline and the follow-up period in patients with proximal and distal tibial, femoral and humeral fractures treated with intramedullary nails. Furthermore, the relationship of any occurred complications to ASLS will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical | Patients with proximal and/or distal tibial, femoral and/or humeral fractures treated with intramedullary nails and the Angular Stable Locking System(ASLS) |
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| Measure | Description | Time Frame |
|---|---|---|
| Surgeon's compliance and handling-oriented questionnaire | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Complications | 6 months | |
| General pain and pain at fracture site assessed by VAS | 6 months | |
| Walking ability in patients with femoral or tibial fractures using the Parker mobility score |
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Inclusion Criteria:
Exclusion criteria:
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orthopedic clinics
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| Name | Affiliation | Role |
|---|---|---|
| Dankward Hoentzsch, MD | BG Unfallklinik Tübingen, 72076 Tübingen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck, Abteilung Unfallchirurgie und Sporttraumatologie | Innsbruck | 6020 | Austria | |||
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| 6 months |
| Charité - Universitätsmedizin Berlin, Centrum für Muskuloskeletale Chirurgie |
| Berlin |
| 13353 |
| Germany |
| Universitätsklinikum Mainz, Klinik und Poliklinik für Unfallchirurgie | Mainz | 55131 | Germany |
| BG Unfallklinik Tübingen | Tübingen | 72076 | Germany |
| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| D005264 | Femoral Fractures |
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D007869 | Leg Injuries |
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