Lesion of Ligament of Wrist and/or Hand Clinical Trial
Official title:
Prospective Clinical Evaluation of the Bioabsorbable SportWelding FijiAnchor® for Ligament Repair of the Hand and Hand Wrist
| Verified date | November 2015 |
| Source | SportWelding GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 30 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Having a condition requiring (re)fixation or (re)construction of ligaments in the hand or hand wrist - Being able to comprehend, sign, and date the written informed consent form (ICF)); and - Being able to visit the hospital to be examined the repaired region after the procedure. Exclusion Criteria: - Having serious concomitant disease - Being pregnant - Having the control hand not suitable to serve as comparator |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Univ.-Klinik für Unfallchirurgie | Innsbruck | Tyrol |
| Lead Sponsor | Collaborator |
|---|---|
| SportWelding GmbH |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Primary | Procedure success | No dislodged/broken anchor nor ruptured sutures observed at 2, 6 and 12 weeks post operative evaluation | 12 weeks | Yes |
| Secondary | 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 | No |
| Secondary | Adverse events | All adverse events will be recorded | From Day 1 to 12 months | Yes |