Actively Recruiting
Norwegian Distal Ulna Resection vs. Replacement Study Comparing Darrach Procedure and Ulnar Head Prosthesis for Wrist Osteoarthritis
Led by Ostfold Hospital Trust · Updated on 2024-04-08
40
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Osteoarthritis of the joint between the forearm bones at the wrist, called the distal radioulnar joint (DRUJ), can cause pain and reduce the ability to lift and rotate the forearm. This condition often develops after fractures, ligament injuries, or degenerative wrist disease. Researchers are comparing two surgical treatments—the Darrach procedure, which removes the ulnar head, and ulnar head replacement with a prosthetic implant—to determine which method provides better function and fewer complications in patients with stable but painful DRUJ osteoarthritis. The study involves two groups: one undergoing the Darrach procedure and the other receiving a ulnar head replacement using the Herbert Ulnar Head Prosthesis. The surgeries are performed at several hand surgery centers in Norway, following standardized methods. Both groups receive the same postoperative care and follow-up schedule. Participants are randomly assigned to one of the two surgical options to fairly compare outcomes. Participants will be assessed before surgery and then followed up at 3 months, 1 year, and 5 years after the procedure. Evaluations include range of motion, grip strength, functional scores such as the Norwegian version of Quick DASH, patient-related wrist and hand evaluations, pain scales, and monitoring for any complications or additional surgeries. The study aims to gather detailed long-term data on how each surgery affects wrist function and pain over five years.
CONDITIONS
Brief 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
- Age between 30 and 75 years
- Able to provide informed consent
You will not qualify if you...
- Active inflammatory disease with significant joint destruction
- Persons with low physical demand
- Significant instability of the distal radioulnar joint
- Active infections or poor soft tissue condition in the hand
- Accidental wounds on the hand planned for surgery
- General contraindications for surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo either distal ulna resection (Darrach procedure) or ulnar head replacement with a Herbert implant, followed by immediate post-operative care.
1 surgery visit and approximately 2 post-operative visits
Duration - 5 years
Participants have follow-up visits to assess range of motion, grip strength, functional scores, and monitor for complications or reoperations.
Visits at 3 months, 1 year, and 5 years post-surgery
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
J
Jan-Ragnar Haugstvedt, PhD
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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