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

NCT06824545 | Not Yet Recruiting

• 1 other identifier: 24-1667
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Osteolysis

Outcome Measures

Primary Outcomes (1)

• Rates of Osteolysis

  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.

  18 months

Study Arms (1)

Patients who underwent hand & wrist surgery with suture anchor implantation over the past 10 years.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between 2014 \& 2024 who were billed for one of the following CPT codes: 25310, 25320, 25447, 26480, 26540, 226541, 26542, and 26545.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

UCHealth Steadman Hawkins Clinic Inverness

Englewood, Colorado, 80112, United States

Location

MeSH Terms

Conditions

Osteolysis

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Louis Catalano, MD

CONTACT

(914) 924-0387; louis.catalano@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)