About this trial
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
This trial does not accept healthy volunteersQualifiers
painful osteoarthritis distal radioulnar joint
stable DRUJ
Disqualifiers
activ inflammatory disease with significant destruction of the joint
"low demand" persons
significant instability i DRUJ
active infections, poor soft tissue conditions
Trial design
Parallel
Treatments tested in this trial
Darrach
Procedure/SurgerySurgical treatment of painful DRU osteoarthritis with resection of distal ulna
Prosthesis
Procedure/SurgerySurgical treatment of painful DRU osteoarthritis with distal ulna replacement with Herbert implant
Treatment groups
Trial outcomes
Primary outcomes
Norwegian version of Quick DASH (Quick Disability Arm Shoulder Hand) score
specific patient reported outcome measure, scale with range 0-100, with 0 defined as best possible and 100 as worst possible outcome
Secondary outcomes
Norwegian vesrion of PRWHE (Patient Rated Wrist Hand Evaluation) score
Hand specific patient reported outcome measure, scale with range 0-100, with 0 defined as best and 100 as worst subjective outcome
Visual Analogue Scale (VAS) pain scale
subjective evaluation of pain intensity, a scale with range 0-10 with 0 defined as best possible and 10 as worst outcome
Active range of motion
objective measurement of movements in degrees, a scale with range 0-180 degrees.
Grip strength
Measurement of grip strength of the hand, scale with range 0-100 kilograms
Sponsors and contacts
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