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

University of Colorado Denver (CU Denver)

Status: Not yet enrolling

Conditions: Osteolysis

Study type: Observational

Funder types: Other

Identifiers

NCT06824545

24-1667

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

180 participants in 1 patient group

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