Registry of Arthrex Hand and Wrist Products

Arthrex

Status: Enrolling

Conditions: Carpal Fusion (Arthrodesis) of the Hand; Scapholunate Ligament Reconstruction; Carpometacarpal Joint Arthroplasty; Ulnar/Radial Collateral Ligament Reconstruction; Ligament Repair or Reconstruction; 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 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.

Enrollment: 600 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 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. -

Trial design

600 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

Treatment:

Device: Products listed in cohort description