Registry of Arthrex Hand and Wrist Products

Study Overview
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Brief Summary
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A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products

Detailed Description
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The objective of the registry is to evaluate the continued safety and effectiveness of the Arthrex hand and wrist products including include the Biocomposite™ or PEEK PushLock® Anchors for ulnar/radial collateral ligament reconstruction, DX SwiveLock SL (3.5 x 8.5mm) is indicated for ligament repair or reconstruction (e.g. scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction, digital tendon transfers, and carpometacarpal Joint Arthroplasty). Headless Compression Screws for small bone fragments and arthrodesis Tenodesis Screw™ (Biocomposite and PEEK), for ulnar collateral ligament reconstruction,Corkscrew® Titanium for (scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction (Micro Corkscrew), digital tendon transfers (Nano Corkscrew) and DynaNite Nitinol Staples for carpal fusion (arthrodesis) of the hand.

Official Title
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Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products

Conditions
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Ulnar/Radial Collateral Ligament Reconstruction, Ligament Repair or Reconstruction, Small Bone Fragments and Arthrodesis, Scapholunate Ligament Reconstruction, Carpal Fusion (Arthrodesis) of the Hand, Digital Tendon Transfers, Carpometacarpal Joint Arthroplasty

Intervention / Treatment
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* Device: Products listed in cohort description


Participation Criteria
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Eligibility Criteria
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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 study 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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Products listed in Descriptions<br>Biocomposite™ or PEEK PushLock, DX SwiveLock SL, Headless Compression Screws, Tenodesis Screw (Biocomposite and PEEK), Corkscrew® Titanium (Nano and Micro-Corkscrew), DynaNite Nitinol Staples | Device: Products listed in cohort description<br>* Depending on approved indication per product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |