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Norwegian Distal Ulna Resection - Replacement Study

NCT04074863 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-08

No results posted yet for this study

Summary

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

  • Osteoarthritis Wrist

Interventions

PROCEDURE

Darrach

Surgical treatment of painful DRU osteoarthritis with resection of distal ulna

PROCEDURE

Prosthesis

Surgical treatment of painful DRU osteoarthritis with distal ulna replacement with Herbert implant

Sponsors & Collaborators

  • Ostfold Hospital Trust

    lead OTHER

Principal Investigators

  • Istvan Zoltan Rigo, PhD · Ostfold Hospital Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04074863 on ClinicalTrials.gov