Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Arthrex, Inc.
Summary
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Description
The objective of the registry is to evaluate the continued safety and effectiveness of the Arthrex hand and wrist products including the Biocomposite or PEEK PushLock® Anchors for ulnar/radial collateral ligament reconstruction; and/or the DX SwiveLock® SL Anchors (3.5 x 8.5mm) for ligament repair or reconstruction (e.g. scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction, and carpometacarpal joint arthroplasty); and/or, the Headless Compression Screws for small bone fragments; and/or, the arthrodesis Tenodesis Screw (Biocomposite and PEEK), for ulnar collater…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Subject requires surgery using Arthrex hand and wrist implants included in the registry. 2. Subject is 18 years of age or over. 3. Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state). 4. Subject signed informed consent and is willing and able to comply with all registry requirements Exclusion Criteria: 1. Insufficient quantity or quality of bone. 2. Blood supply limitations and previous infections, which may retard healing. 3. Foreign-body sensitivity or foreign-body reactions. 4. Any active infection or blood…
Interventions
- DeviceProducts listed in cohort description
Depending on approved indication per product
Locations (5)
- MORE FoundationPhoenix, Arizona
- Banner HealthTuscon, Arizona
- University of IowaIowa City, Iowa
- Duke UniversityDurham, North Carolina
- West Virginia UniversityMorgantown, West Virginia