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Registry of Arthrex Hand and Wrist Products

Registry of Arthrex Hand and Wrist Products

Recruiting
18 years and older
All
Phase N/A

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Overview

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 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.

Eligibility

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 study 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. -

Study details
    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

NCT05046600

Arthrex, Inc.

26 January 2024

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