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Norwegian Distal Ulna Resection vs. Replacement Study. A Prospective Randomized Multicenter Study

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• painful osteoarthritis distal radioulnar joint

• stable DRUJ

Locations
Other Locations
Norway
Haukeland University Hospital
NOT_YET_RECRUITING
Bergen
Innlandet Hospital Trust
NOT_YET_RECRUITING
Lillehammer
Østfold Hospital Trust
RECRUITING
Moss
Oslo University Hospital
RECRUITING
Oslo
University Hospital of North Norway
NOT_YET_RECRUITING
Tromsø
University Hospital of St Olav
NOT_YET_RECRUITING
Trondheim
Contact Information
Primary
Istvan Zoltan Rigo, PhD
istvan.zoltan.rigo@so-hf.no
+47 69860000
Backup
Jan-Ragnar Haugstvedt, PhD
Jan-Ragnar.Haugstvedt@so-hf.no
+47 69860000
Time Frame
Start Date: 2020-09-16
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 40
Treatments
Active_comparator: Darrach
Surgical procedure: resection of distal ulna
Active_comparator: Prosthesis
Surgical procedure: ulnar head replacement
Related Therapeutic Areas
Sponsors
Leads: Ostfold Hospital Trust

This content was sourced from clinicaltrials.gov