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NCT Number: NCT06824545

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.

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Key information

Conditions

Osteolysis Bone Diseases Bone Resorption Musculoskeletal Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCHealth Steadman Hawkins Clinic Inverness

Englewood, Colorado, 80112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Rates of Osteolysis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Louis Catalano, MD

CONTACT

[email protected]

(914) 924-0387

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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