Actively Recruiting

Phase Not Applicable
Age: 30Years - 75Years
All Genders
ID04074863

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

Age: 30Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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