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The SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying ultrasonic energy. This provides an intimate bond between implant and bone delivering immediate stability.
The purpose of this study is to evaluate the surgical and clinical outcome of the SportWelding Fiji Anchor in ligament repair of the hand and hand wrist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SportWelding Fiji Anchor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SportWelding Fiji Anchor | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operation success | Technical success confirmed at the end of surgery by mean of an assessment form (e.g anchor insertion without breaking and suture without pulling off from the tissue during surgery). | Day 1 |
| Procedure success | No dislodged/broken anchor nor ruptured sutures observed at 2, 6 and 12 weeks post operative evaluation | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical function | Dash (Disabilities of the Arm, Shoulder and Hand) Score, PRWE (Patient-Related-Wrist-Evaluation) Score and strength of the operated and the non-operated control hand will be recorded after 6 and 12 months. | 3 and 6 months |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rohit Arora, MD | Univ.-Klinik für Unfallchirurgie Innsbruck, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ.-Klinik für Unfallchirurgie | Innsbruck | Tyrol | 6020 | Austria |
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All adverse events will be recorded |
| From Day 1 to 12 months |