Lesion of Ligament of Wrist and/or Hand
Conditions
Brief summary
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.
Interventions
DEVICESportWelding Fiji Anchor
Sponsors
SportWelding GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operation success | Day 1 | 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). |
| Procedure success | 12 weeks | No dislodged/broken anchor nor ruptured sutures observed at 2, 6 and 12 weeks post operative evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical function | 3 and 6 months | 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. |
| Adverse events | From Day 1 to 12 months | All adverse events will be recorded |
Countries
Austria
Outcome results
None listed