NCT06290986|Unknown
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Sponsor study identifier
interventional
64
1 country
1
Study Start
September 26, 2022
Actual (reported)Primary Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a randomized controlled trial comparing the Pyrocardan® implant (intervention group) with the standard ligament reconstruction and tendon interposition (LRTI) (control group). All Danish citizens with osteoarthritis of the thumb carpometacarpal joint referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be considered for participation in the trial. The following exclude from participation in the study: Below 40 years of age; cognitive or linguistic impairment; osteoarthritis of other carpal bones; previous surgery in the carpometacarpal joint; patients with rheumatoid arthritis. A total of 64 patients will be included. The primary outcome is the patient reported outcomes questionnaire; Quick-DASH. The secondary outcomes are patient-reported outcomes, functional outcomes, radiographic outcomes, readmission, complications, revisions. The patients are examined before surgery and 3, 6, 12 and 24 months after the operation. The patients are also contacted after 5 and 10 years.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2022
Actual (reported)February 14, 2024
Actual (reported)March 4, 2024
Actual (reported)September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Patient-reported outcome: QuickDASH
Quick version of the Disability of the arm, shoulder and hand questionnaire (QuickDASH): 0-100 p, higher score = more disability
6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Patient-reported outcome
6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Strength measurements
6 weeks, 3 months, 6 months, 1 year, 2 years
Radiographs
6 weeks
Return to occupation
1 year
Biconcave-shaped CMC-1 interposition implant
Weilby slightly modified as described by Burton and Pellegrini
Herlev and Gentofte Hospital
Hellerup, 2900, Denmark
Jens Joergsholm, MD
Herlev Gentofte Hospital
First Submitted
February 14, 2024
First Posted
March 4, 2024
Study Start
September 26, 2022
Actual (reported)Primary Completion
September 30, 2025
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 4, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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