Clinical Evaluation of the SportWelding FijiAnchor® in Hand and Hand Wrist Surgery
This trial is active, not recruiting.
|Condition||lesion of ligament of wrist and/or hand|
|Treatment||sportwelding fiji anchor|
|Start date||January 2014|
|End date||June 2016|
|Trial size||30 participants|
|Trial identifier||NCT02042846, Spo-01|
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.
|Intervention model||single group assignment|
time frame: Day 1
time frame: 12 weeks
time frame: 3 and 6 months
time frame: From Day 1 to 12 months
Male or female participants at least 18 years old.
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
|Official title||Prospective Clinical Evaluation of the Bioabsorbable SportWelding FijiAnchor® for Ligament Repair of the Hand and Hand Wrist|
|Principal investigator||Rohit Arora, MD|
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