Actively Recruiting
Norwegian Distal Ulna Resection - Replacement Study
Led by Ostfold Hospital Trust · Updated on 2024-04-08
40
Participants Needed
6
Research Sites
484 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Norwegian Distal Ulna Resection - Replacement Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Painful osteoarthritis of the distal radioulnar joint
- Stable distal radioulnar joint (DRUJ)
- Age between 30 and 75 years
- Seeking treatment for stable but painful DRUJ osteoarthritis
You will not qualify if you...
- Active inflammatory disease with significant joint destruction
- Low demand persons
- Significant instability in the distal radioulnar joint (DRUJ)
- Active infections or poor soft tissue conditions
- Accidental wound on the operated hand
- General contraindications for surgery
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Innlandet Hospital Trust
Lillehammer, Oppland, Norway, 2629
Not Yet Recruiting
2
Haukeland University Hospital
Bergen, Norway, 5021
Not Yet Recruiting
3
Oslo University Hospital
Oslo, Norway, 0424
Actively Recruiting
4
University Hospital of North Norway
Tromsø, Norway, 9038
Not Yet Recruiting
5
University Hospital of St Olav
Trondheim, Norway, 7006
Not Yet Recruiting
6
Østfold Hospital Trust
Moss, Østfold fylke, Norway, 1535
Actively Recruiting
Research Team
I
Istvan Zoltan Rigo, PhD
CONTACT
J
Jan-Ragnar Haugstvedt, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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