Actively Recruiting

Phase Not Applicable
Age: 30Years - 75Years
All Genders
NCT04074863

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

Age: 30Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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