Norwegian Distal Ulna Resection - Replacement Study
Key facts
- Where
- Bergen, Lillehammer, Moss, Oslo, Tromsø, and Trondheim, NorwaySee the 6 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 75 years old?
Source: NCT04074863, who can take part
Where in Norway
- Haukeland University HospitalBergen, NorwayContact: Eivind Strandenes, MDNot yet recruiting
- Innlandet Hospital TrustLillehammer, NorwayContact: Ole Anton Kragh Fosse, MDNot yet recruiting
- Østfold Hospital TrustMoss, NorwayContact: Istvan Zoltan Rigo, PhDTaking people
- Oslo University HospitalOslo, NorwayContact: Magne Røkkum, PhD, ProfTaking people
- University Hospital of North NorwayTromsø, NorwayContact: Hebe Desiree Kvernmo, PhD, ProfNot yet recruiting
- University Hospital of St OlavTrondheim, NorwayContact: Heike Brigitta Zeitlemann, MDNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ostfold Hospital Trust
- Trial code
- NCT04074863
- Record updated
- 8 April 2024
- Original description
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.Read full original descriptionShow less
Norwegian Distal Ulna Resection vs. Replacement Study. A Prospective Randomized Multicenter Study
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.
Inclusion: painful osteoarthritis distal radioulnar joint; stable DRUJ.
Exclusion: general contraindications for surgery; activ inflammatory disease with significant destruction of the joint; active infections, poor soft tissue conditions; "low demand" persons; significant instability i DRUJ; accidental wound on the operated hand.