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NCT05046600RecruitingAccepts Healthy Volunteers

Registry of Arthrex Hand and Wrist Products

Arthrex, Inc.

Start Date

7/20/2021

Completion Date

12/1/2025

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

Eligibility Criteria

Age Range: 18 years to No maximum

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 supply limitations. 5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period. 6. Subjects that are skeletally immature -

Interventions

DEVICE

Products listed in cohort description

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Conditions

Ulnar/Radial Collateral Ligament ReconstructionLigament Repair or ReconstructionSmall Bone Fragments and ArthrodesisScapholunate Ligament ReconstructionCarpal Fusion (Arthrodesis) of the HandDigital Tendon TransfersCarpometacarpal Joint ArthroplastyArthrodesisDigital Tendon TransferDistal Radius Fracture Fixation

Locations

MORE Foundation

Phoenix, Arizona 85023

United States

Banner Health

Tuscon, Arizona 85006

United States

University of Iowa

Iowa City, Iowa 52242

United States

Duke University

Durham, North Carolina 27705

United States

West Virginia University

Morgantown, West Virginia 26501

United States