NCT06290986

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

February 14, 2024

Last Update Submit

February 26, 2024

Conditions

CMC-1 OsteoarthritisTrapeziometacarpal Osteoarthritis

Keywords

Hand OsteoarthritisPyrocardanCMC-1Trapeziometacarpal OsteoarthritisOsteoarthritisJoint Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

Study Arms (2)

Pyrocardan® implant

ACTIVE COMPARATOR
Procedure: Pyrocardan® implant

Ligament reconstruction and tendon interposition (LRTI)

ACTIVE COMPARATOR
Procedure: Ligament reconstruction and tendon interposition (LRTI)

Interventions

Pyrocardan® implantPROCEDURE

Biconcave-shaped CMC-1 interposition implant

Pyrocardan® implant
Ligament reconstruction and tendon interposition (LRTI)PROCEDURE

Weilby slightly modified as described by Burton and Pellegrini

Ligament reconstruction and tendon interposition (LRTI)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthritis of the trapeziometacarpal joint of the thumb.
  • Insufficient effect of non-surgical treatment with symptoms severe enough to justify surgical treatment.
  • ASA score 1-3, physically fit for surgery and rehabilitation

You may not qualify if:

  • Below 40 years of age
  • Cognitive or linguistic impairment
  • Osteoarthritis in other carpal bones (STT OA and others)
  • Previous surgical treatment in the trapeziometacarpal joint.
  • Patients with rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev and Gentofte Hospital

Hellerup, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

OsteoarthritisJoint Diseases

Condition Hierarchy (Ancestors)

ArthritisMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jens Joergsholm, MD

    Herlev Gentofte Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Jørgsholm, MD

CONTACT

+4551339705Jens.bertel.joergsholm.01@regionh.dk

Rasmus Wejnold Jørgensen, MD, PhD

CONTACT

+4538673315rasmus.wejnold.joergensen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD student

Study Record Dates

First Submitted

February 14, 2024

First Posted

March 4, 2024

Study Start

September 26, 2022

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

March 4, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)