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Joint distraction versus trapeziectomy with ligament reconstruction and tendon interposition

Joint distraction for CMC1 osteoarthritis: joint distraction versus trapeziectomy with ligament reconstruction and tendon interposi-tion - RCT distraction vs Weilby

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON61410
Enrollment
95
Registered
2025-07-24
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpometacarpal (CMC) joint osteoarthritis, Removal of the trapezium bone, Weilby Basal thumb joint arthritis

Interventions

The intervention will be either 6 weeks of joint distraction or trapeziectomy with LRTI.

Sponsors

St. Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age 18-65 years - Ability to read and speak Dutch sufficiently to be able to understand study information, complete questionnaires and to understand distractor maintenance and hygiene instructions  - Radiological joint damage: Eaton Littler classification II or III  - Failed non-operative treatment (e.g. splint for at least 3 months)  - Established indication for invasive surgical treatment - Willingness to participate in the study and ability to understand distractor  maintenance and hygiene instructions - Treatment location: St. Antonius Ziekenhuis in Nieuwegein or Utrecht  

Exclusion criteria

Exclusion criteria: - Unable to attend follow-up appointments - Inflammatory or rheumatoid arthritis present or in history - >30% joint subluxation - Involvement of STT joint - A known psychiatric disease - Surgical treatment of the CMC joint in the past - Use of immunosuppressive or chemotherapeutic drugs - Hypermobility syndrome  - Having syndromatic diseases   

Design outcomes

Primary

MeasureTime frame
This study will test the primary hypothesis that joint distraction yields similar outcomes, or even greater symptom reduction, compared to trapeziectomy with LRTI. This will be assessed using the PROMIS Physical Function Upper Extremity (PROMIS UE short form) score one year after surgery.

Secondary

MeasureTime frame
 - There is no difference between group A (6 weeks distraction) and group B (trapeziectomy with LRTI) in MHQ, VAS pain, VAS satisfaction, VAS function, VAS stiffness, range of  motion, and strength at 1 year after CMC1 joint distraction  - There are no factors associated with PROMIS UE short form and MHQ at 1 year, including patient  characteristics, PHQ-2 and PCS.  - For the long-term effects, we will test all hypotheses mentioned above at 1 year 2 years and 5 years post-distraction   

Countries

Netherlands

Contacts

Public ContactCHC Houtsma

St. Antonius Ziekenhuis

c.houtsma@antoniusziekenhuis.nl0615284250

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 10, 2026