RecruitingNot ApplicableNCT04074863

Norwegian Distal Ulna Resection - Replacement Study

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


Sponsor

Ostfold Hospital Trust

Enrollment

40 participants

Start Date

Sep 16, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 30 YearsMax Age: 75 Years

Inclusion Criteria2

  • painful osteoarthritis distal radioulnar joint
  • stable DRUJ

Exclusion Criteria6

  • activ inflammatory disease with significant destruction of the joint
  • "low demand" persons
  • significant instability i DRUJ
  • active infections, poor soft tissue conditions
  • accidental wound on the operated hand
  • general contraindications for surgery

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Interventions

PROCEDUREDarrach

Surgical treatment of painful DRU osteoarthritis with resection of distal ulna

PROCEDUREProsthesis

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


Locations(6)

Innlandet Hospital Trust

Lillehammer, Oppland, Norway

Haukeland University Hospital

Bergen, Norway

Oslo University Hospital

Oslo, Norway

University Hospital of North Norway

Tromsø, Norway

University Hospital of St Olav

Trondheim, Norway

Østfold Hospital Trust

Moss, Østfold fylke, Norway

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NCT04074863


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