Actively Recruiting
Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Led by Arthrex, Inc. · Updated on 2025-06-26
650
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the continued safety and effectiveness of various Arthrex hand and wrist products used for surgeries involving ligament reconstruction, repair, and arthrodesis. These products include different types of anchors, screws, and staples designed for conditions such as ulnar/radial collateral ligament reconstruction, scapholunate ligament reconstruction, digital tendon transfers, carpal fusion, and distal radius fracture fixation. The registry collects data from multiple centers to monitor outcomes over time. The study involves the use of several Arthrex devices including Biocomposite or PEEK PushLock Anchors, DX SwiveLock SL Anchors, Headless Compression Screws, Tenodesis Screws, Corkscrew Titanium Anchors, DynaNite Nitinol Staples, and KreuLock Screws. These devices are applied according to their approved surgical indications for hand and wrist conditions. Participants undergo surgery using these implants, and their progress is recorded in the registry. Participants are assessed before surgery and followed up at 3, 6, and 12 months postoperatively. Assessments include patient surveys such as the Visual Analogue Scale (VAS) for pain and the Veterans Rand 12-Item Health Survey (VR-12) to evaluate health status. Researchers monitor patient recovery, device safety, and effectiveness through these measures. The study is open to adults requiring surgery with these products and includes long-term follow-up to observe treatment outcomes.
CONDITIONS
Brief Title
Registry of Arthrex Hand and Wrist Products
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject requires surgery using Arthrex hand and wrist implants included in the registry.
- Subject is 18 years of age or over.
- Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
- Subject signed informed consent and is willing and able to comply with all registry requirements
You will not qualify if you...
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections, which may retard healing.
- Foreign-body sensitivity or foreign-body reactions.
- Any active infection or blood supply limitations.
- Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
- Subjects that are skeletally immature -
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 day or until discharge
Participants undergo surgery using Arthrex hand and wrist implants followed by immediate post-operative care.
1 surgery visit (in-person)
Duration - 12 months
Participants are followed after surgery to monitor safety and effectiveness of the implants.
Visits at preoperative baseline and at 3, 6, and 12 months postoperatively
Trial Site Locations
Total: 5 locations
1
MORE Foundation
Phoenix, Arizona, United States, 85023
Actively Recruiting
2
Banner Health
Tuscon, Arizona, United States, 85006
Actively Recruiting
3
University of Iowa
Iowa City, Iowa, United States, 52242
Terminated
4
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
5
West Virginia University
Morgantown, West Virginia, United States, 26501
Actively Recruiting
Research Team
J
Justin F Moss, DHSc,CCRP
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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