Registry of Arthrex Hand and Wrist Products

Arthrex, Inc.650 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

650

Conditions

Ulnar/Radial Collateral Ligament Reconstruction Ligament Repair or Reconstruction Small Bone Fragments and Arthrodesis Scapholunate Ligament Reconstruction

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 -

Locations (5)

MORE Foundation

Phoenix, Arizona, United States

RECRUITING

Banner Health

Tuscon, Arizona, United States

RECRUITING

University of Iowa

Iowa City, Iowa, United States

TERMINATED

Duke University

Durham, North Carolina, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

To assess a change in Visual Analogue Scale (VAS) survey

Patient reported pain scale 0-10 point scale (0 min,10 max)

Time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively

Secondary Outcomes

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

Time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively

Registry of Arthrex Hand and Wrist Products

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts