Norwegian Distal Ulna Resection - Replacement Study
Recruiting now · Not applicable
Conditions studied: Osteoarthritis Wrist
In brief
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.
Key facts
- Study ID
- NCT04074863
- Run by
- Ostfold Hospital Trust
- People needed
- 40
- Starts
- 2020-09-16
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2024-04-08
Who can join
Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- painful osteoarthritis distal radioulnar joint
- stable DRUJ
You may not qualify if…
- 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 it is running
- Oslo University Hospital — Oslo, Norway (enrolling)
- Østfold Hospital Trust — Moss, Østfold fylke, Norway (enrolling)
- Innlandet Hospital Trust — Lillehammer, Oppland, Norway
- Haukeland University Hospital — Bergen, Norway
- University Hospital of North Norway — Tromsø, Norway
- University Hospital of St Olav — Trondheim, Norway
Full record on ClinicalTrials.gov
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