Comparing two surgical options for thumb base osteoarthritis
A Randomized Comparison Between Trapeziectomy and Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis
NA · Karolinska Institutet · NCT04210687
This study is testing which of two thumb surgeries helps people with painful thumb arthritis feel better and use their hands more easily.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT04210687 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of trapeziectomy and trapeziometacarpal limited excision in treating thumb base osteoarthritis in 90 patients. Participants will be randomly assigned to receive one of the two surgical interventions. The study aims to evaluate pain relief and functional outcomes following each procedure. Patients eligible for the trial must have painful osteoarthritis in the thumb base and have undergone conservative treatment for over six months.
Who should consider this trial
Good fit: Ideal candidates are individuals with painful thumb base osteoarthritis who have not found relief from conservative treatments.
Not a fit: Patients with rheumatoid arthritis or those who have had recent intra-articular injections in the affected joint may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective surgical option for managing thumb base osteoarthritis.
How similar studies have performed: Other studies have explored surgical options for thumb osteoarthritis, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test). * Pain at rest. * Conservative treatment \>6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection) Exclusion Criteria: * Rheumatoid arthritis. * Ongoing infection in the hand or wrist. - * History of gout or pseudo gout. * Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). * Intra-articular injection in the affected joint within 6 months. * Eaton Littler class 4 (STT joint involved).
Where this trial is running
Stockholm
- Karolinska Institutet — Stockholm, Sweden (RECRUITING)
Study contacts
- Principal investigator: Maria Wilcke, MD PhD — Karolinska Instituet
- Study coordinator: Maria Wilcke, MD PhD
- Email: maria.wilcke@regionstockholm.se
- Phone: +46708294613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thumb Osteoarthritis