NCT04074863 Norwegian Distal Ulna Resection - Replacement Study
| NCT ID | NCT04074863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ostfold Hospital Trust |
| Condition | Osteoarthritis Wrist |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-09-16 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2020-09-16 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Osteoarthritis of the joint between the forearm bones at the wrist (distal radioulnar joint, DRUJ) is a common sequel of fracture and ligament injuries or degenerative disease of the wrist. Intact DRUJ is important for normal load transfer from the hand to the forearm. DRUJ osteoarthritis leads to pain and decreased lifting capacity and rotation of the forearm. The standard treatment is resection of the ulnar head, known as the Darrach procedure. After the resection there is no longer contact in the affected joint, however, some patients can experience instability or impingement between the forearm bones. With ulnar head implant replacement may the load transfer and the stability between the forearm bones less affected. Studies with good long term results are published with both resection and replacement. However, these methods were never compared and thus it is not clear, which of the methods gives the best clinical result and less complications. The aim of this study is to compare Darrach procedure with ulnar head replacement in a prospective randomized multicenter study. Several hand surgical centers form Norway would participate this study. Individuals seeking treatment for their stable but painful DRUJ joints will be included and randomized to either Darrach procedure or ulnar head implant. Participants will be followed up to 5 years. Range of motion and grip strength measures and functional scores would be registered before operation, after 3 months, 1 and 5 years. Eventual complications and reoperations would be also registered.
Eligibility 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
Contact & Investigator
Istvan Zoltan Rigo, PhD
PRINCIPAL INVESTIGATOR
Ostfold Hospital Trust
Frequently Asked Questions
Who can join the NCT04074863 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Osteoarthritis Wrist. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04074863 currently recruiting?
Yes, NCT04074863 is actively recruiting participants. Contact the research team at istvan.zoltan.rigo@so-hf.no for enrollment information.
Where is the NCT04074863 trial being conducted?
This trial is being conducted at Lillehammer, Norway, Bergen, Norway, Oslo, Norway, Tromsø, Norway and 2 additional locations.
Who is sponsoring the NCT04074863 clinical trial?
NCT04074863 is sponsored by Ostfold Hospital Trust. The principal investigator is Istvan Zoltan Rigo, PhD at Ostfold Hospital Trust. The trial plans to enroll 40 participants.