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

NCT ID: NCT06824545

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Osteolysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCHealth Steadman Hawkins Clinic Inverness

Englewood, Colorado, United States

Site Status

Countries

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United States

Central Contacts

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Louis Catalano, MD

Role: CONTACT

(914) 924-0387

Other Identifiers

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24-1667

Identifier Type: -

Identifier Source: org_study_id

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