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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteolysis

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Louis Catalano, MD; Phone Number: (914) 924-0387; Email: louis.catalano@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80112
      • UCHealth Steadman Hawkins Clinic Inverness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2026

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Osteolysis
• Other Study ID Numbers: 24-1667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No