OsteolysisNCT06824545
Incidence & Clinical Significance of Osteolysis Following PEEK Suture Anchor Use in Hand & Wrist Surgery
An observational study of Osteolysis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This prospective observational study evaluates the incidence \& clinical significance of osteolysis following polyetheretherketone (PEEK) suture anchor use in hand \& wrist surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Osteolysis
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 10 Dec 2026
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Systematic inflammatory / autoimmune disease or immune-modulatory drug use.
- History of revision surgery of the body part of interest.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCHealth Steadman Hawkins Clinic Inverness
Englewood, Colorado, 80112
About this study
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.
- Conditions
- Osteolysis
- Medical subject headings
- Osteolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent hand & wrist surgery with suture anchor implantation over the past 10 years. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Jan 2026 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteolysisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824545
- Sponsor's protocol ID
- 24-1667
- Status last verified
- Sep 2025
- First submitted
- 7 Feb 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence & Clinical Significance of Osteolysis Following PEEK Suture Anchor Use in Hand & Wrist Surgery
- ClinicalTrials.gov ID
- NCT06824545
- Acronym / sponsor ID
- 24-1667
- Conditions
- Osteolysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent hand & wrist surgery with suture anchor implantation over the past 10 years. | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Systematic inflammatory / autoimmune disease or immune-modulatory drug use.
- History of revision surgery of the body part of interest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteolysis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louis Catalano, MD ((914) 924-0387, louis.catalano@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Osteolysis (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.