Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
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 collateral ligament reconstruction; and/or, the Corkscrew® Titanium Anchor (Micro Corkscrew® Anchor) for ulnar/radial collateral ligament reconstruction, digital tendon transfers (Nano Corkscrew® Anchor); and/or, the DynaNite® Nitinol Staples for carpal fusion (arthrodesis) of the hand; and/or, the KreuLock™ Screws for Distal Radius
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Products listed in Descriptions | Biocomposite™ or PEEK PushLock, DX SwiveLock SL, Headless Compression Screws, Tenodesis Screw (Biocomposite and PEEK), Corkscrew® Titanium (Nano and Micro-Corkscrew), DynaNite Nitinol Staples KreuLock Screws |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Products listed in cohort description | Device | Depending on approved indication per product |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess a change in Visual Analogue Scale (VAS) survey | Patient reported pain scale 0-10 point scale (0 min,10 max) | Preoperatively, 3 months, 6 months and 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| To assess a change in Veterans Rand 12-Item Health Survey (VR-12) | Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring scores up | Preoperatively, 3 months, 6 months and 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Disabilities of the Arm, Shoulder and Hand Score (QDASH). | Self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. | Preoperatively, 3 months, 6 months and 12 months postoperatively |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Approximately 50 subjects, male and female, 18 years of age or older will be enrolled for each product and material.
Subjects will be recruited from the surgeon's patient population or referrals from other physicians.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justin F Moss, DHSc,CCRP | Contact | 7705844972 | justin.moss@arthrex.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MORE Foundation | Recruiting | Phoenix | Arizona | 85023 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Banner Health | Recruiting | Tuscon | Arizona | 85006 | United States |
|
| University of Iowa | Terminated | Iowa City | Iowa | 52242 | United States |
| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
|
| West Virginia University | Recruiting | Morgantown | West Virginia | 26501 | United States |
|
| ID | Term |
|---|---|
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided