Registry to evaluate safety and effectiveness of hand and wrist products
Official title: Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Run by Arthrex, Inc. · NCT05046600 · Data updated 2026-11-12
This study is testing how safe and effective certain hand and wrist surgical products are for patients who need surgery on their hands or wrists.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 650 (estimated) |
| Sponsor | Arthrex, Inc. Industry-sponsored |
| Locations | 5 sites (Phoenix, Arizona and 4 other locations) |
| Status | Recruiting |
| Started | July 20, 2021 |
| Main results expected | December 1, 2025 |
| Study ends | December 1, 2025 |
| Registry record updated | June 26, 2025 |
| Trial ID | NCT05046600 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and over who require surgery using the specified Arthrex hand and wrist implants.
✕Probably not a fit
Patients with insufficient bone quality, active infections, or conditions that limit their ability to follow post-operative instructions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This registry aims to assess the ongoing safety and effectiveness of various Arthrex hand and wrist products used in surgical procedures. It includes products such as Biocomposite™ and PEEK PushLock® Anchors for ligament reconstruction, as well as other devices for small bone fragments and carpal fusion. The study will collect data from multiple centers to monitor outcomes and complications associated with these implants. Participants will be required to undergo surgery using these specific products and will be followed for their recovery and results.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of hand and wrist surgical products, potentially improving patient outcomes.
How similar studies have gone: While this registry approach is common, the specific evaluation of these Arthrex products is novel and aims to fill gaps in existing literature regarding their long-term safety and effectiveness.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 -
Where it's running
-
MORE Foundation
Phoenix, Arizona, United States Recruiting -
Banner Health
Tuscon, Arizona, United States Recruiting -
Duke University
Durham, North Carolina, United States Recruiting -
West Virginia University
Morgantown, West Virginia, United States Recruiting -
University of Iowa
Iowa City, Iowa, United States Terminated
Study contacts
- Study coordinator: Justin F Moss, DHSc,CCRP
- Email: justin.moss@arthrex.com
- Phone: 7705844972
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.