Incidence & Clinical Significance of Osteolysis Following PEEK Suture Anchor Use in Hand & Wrist Surgery

Not yet recruiting

• Conditions: Osteolysis

• Registration Number: NCT06824545
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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. We hypothesize that PEEK anchors will show significantly greater osteolysis than metallic or bioabsorbable anchors. Furthermore, among all patients with osteolysis, we 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, we hypothesize that osteolysis presence will not correlate with increased UCL laxity upon valgus stress testing compared to the nonoperative thumb.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study Start: 2025-02-10
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-02-10
• Study Completion: 2026-02-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Male or female aged 18 - 99 years-old
• History of hand and/or wrist surgery with suture anchor fixation over the 10-year period between January 1, 2014 and January 1, 2024.
• Possess an en face and/or tangential radiograph of the suture anchor tunnels from either the intra-operative or immediately post-operative (within 14 days) period.

Exclusion Criteria

• Systematic inflammatory / autoimmune disease or immune-modulatory drug use.
• History of revision surgery of the body part of interest.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of Osteolysis	18 months	This analysis focuses on the primary outcome of osteolysis rates within the patient populations who received one of three difference suture anchor types (PEEK, bioabsorbable, or metallic) - as defined by the number of patients per anchor type presenting with \>30% increases in the size of suture anchor tunnels between their immediate \& final post-operative X-ray series.