Registry of Arthrex Hand and Wrist Products

Arthrex

Status: Enrolling

Conditions: Carpal Fusion (Arthrodesis) of the Hand; Scapholunate Ligament Reconstruction; Carpometacarpal Joint Arthroplasty; Distal Radius Fracture Fixation; Ulnar/Radial Collateral Ligament Reconstruction; Digital Tendon Transfer; Ligament Repair or Reconstruction; Arthrodesis; Digital Tendon Transfers; Small Bone Fragments and Arthrodesis

Treatments: Device: Products listed in cohort description

Study type: Observational

Funder types: Industry

Identifiers

NCT05046600

AIRR-0010

Details and patient eligibility

About

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

Full 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

Enrollment: 650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

650 participants in 1 patient group

All Products listed in Descriptions

Description:

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

Treatment:

Device: Products listed in cohort description