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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06824545

Enrollment

180

Registered

2025-02-13

Start date

2026-01-01

Completion date

2026-12-10

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteolysis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactLouis Catalano, MD

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

Outcome results