Comparing two methods for treating wrist osteoarthritis
Norwegian Distal Ulna Resection vs. Replacement Study. A Prospective Randomized Multicenter Study
This study is testing whether a surgery that removes part of the wrist or a surgery that replaces it works better for people with painful wrist arthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Ostfold Hospital Trust Academic / other |
| Locations | 6 sites (Lillehammer, Oppland and 5 other locations) |
| Trial ID | NCT04074863 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of the Darrach procedure, which involves resection of the ulnar head, with ulnar head replacement for treating osteoarthritis of the distal radioulnar joint (DRUJ). Participants will be individuals experiencing stable but painful DRUJ joints, and the study will be conducted as a prospective randomized multicenter trial across several hospitals in Norway. The goal is to determine which method provides better clinical outcomes and fewer complications. Informed consent will be obtained from all participants before enrollment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with painful osteoarthritis of the distal radioulnar joint who have stable joints.
Not a fit: Patients with active inflammatory diseases, significant instability in the DRUJ, or those who are considered 'low demand' may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from wrist osteoarthritis, enhancing their quality of life and functional capacity.
How similar studies have performed: While studies have shown good long-term results for both resection and replacement methods, this study is novel in directly comparing the two approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * painful osteoarthritis distal radioulnar joint * stable DRUJ Exclusion Criteria: * activ inflammatory disease with significant destruction of the joint * "low demand" persons * significant instability i DRUJ * active infections, poor soft tissue conditions * accidental wound on the operated hand * general contraindications for surgery
Where this trial is running
Lillehammer, Oppland and 5 other locations
- Innlandet Hospital Trust — Lillehammer, Oppland, Norway (Not_yet_recruiting)
- Haukeland University Hospital — Bergen, Norway (Not_yet_recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- University Hospital of North Norway — Tromsø, Norway (Not_yet_recruiting)
- University Hospital of St Olav — Trondheim, Norway (Not_yet_recruiting)
- Østfold Hospital Trust — Moss, Østfold fylke, Norway (Recruiting)
Study contacts
- Principal investigator: Istvan Zoltan Rigo, PhD — Ostfold Hospital Trust
- Study coordinator: Istvan Zoltan Rigo, PhD
- Email: istvan.zoltan.rigo@so-hf.no
- Phone: +47 69860000
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.