Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Arthrex, Inc.
- Enrollment
- 650
- Locations
- 5
- Primary Endpoint
- To assess a change in Visual Analogue Scale (VAS) survey
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Detailed 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 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject requires surgery using Arthrex hand and wrist implants included in the registry.
- •Subject is 18 years of age or over.
- •Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
- •Subject signed informed consent and is willing and able to comply with all registry requirements
Exclusion Criteria
- •Insufficient quantity or quality of bone.
- •Blood supply limitations and previous infections, which may retard healing.
- •Foreign-body sensitivity or foreign-body reactions.
- •Any active infection or blood supply limitations.
- •Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
- •Subjects that are skeletally immature -
Outcomes
Primary Outcomes
To assess a change in Visual Analogue Scale (VAS) survey
Time Frame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Patient reported pain scale 0-10 point scale (0 min,10 max)
Secondary Outcomes
- To assess a change in Veterans Rand 12-Item Health Survey (VR-12)(Preoperatively, 3 months, 6 months and 12 months postoperatively)