Incidence & Clinical Significance of Osteolysis Following PEEK Suture Anchor Use in Hand & Wrist Surgery
Part of paid clinical trials in Englewood, Colorado.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT06824545
- Status
- Not Yet Recruiting
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Conditions
- Osteolysis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Study Details
This prospective observational study evaluates the incidence \& clinical significance of osteolysis following polyetheretherketone (PEEK) suture anchor use in hand \& wrist surgery. Building on a pilot study, it focuses on patients undergoing hand \& wrist surgeries with suture anchor implantation over the past 10 years. Patients are grouped by anchor composition: PEEK, metallic, or bioabsorbable. The investigators hypothesize that PEEK anchors will show significantly greater osteolysis than metallic or bioabsorbable anchors. Furthermore, among all patients with osteolysis, the investigators expect no statistically significant differences in patient-reported outcomes (PROs), post-op complications, or revision surgery rates, regardless of anchor type. Lastly, for patients with ulnar collateral ligament (UCL) thumb injuries, the investigators hypothesize that osteolysis presence will not correlate with increased UCL laxity upon valgus stress testing compared to the nonoperative thumb.
Key Dates
- Start date
- Jan 1, 2026
- Status verified
- Sep 2025
- Primary completion
- Dec 10, 2026
- Completion
- Dec 10, 2026
Study Design
- Enrollment
- 180 participants (estimated)
Arms
- Arm: Patients who underwent hand & wrist surgery with suture anchor implantation over the past 10 years.
Primary Outcome Measure
Rates of Osteolysis [ Time Frame: 18 months ]
Central Contacts
- Louis Catalano, MD(914) 924-0387
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCHealth Steadman Hawkins Clinic Inverness | Englewood | Colorado | 80112 | - |