Registry to evaluate safety and effectiveness of hand and wrist products
Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
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 |
|---|---|
| Enrollment | 650 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Arthrex, Inc. Industry-sponsored |
| Locations | 5 sites (Phoenix, Arizona and 4 other locations) |
| Trial ID | NCT05046600 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who require surgery using the specified Arthrex hand and wrist implants.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Phoenix, Arizona and 4 other locations
- 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)
Study contacts
- Study coordinator: Justin F Moss, DHSc,CCRP
- Email: justin.moss@arthrex.com
- Phone: 7705844972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.