Norwegian Distal Ulna Resection - Replacement Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorOstfold Hospital Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

painful osteoarthritis distal radioulnar joint

stable DRUJ

Disqualifiers

activ inflammatory disease with significant destruction of the joint

"low demand" persons

significant instability i DRUJ

active infections, poor soft tissue conditions

Trial design

Design model

Parallel

Treatments tested in this trial

  • Darrach

    Procedure/Surgery

    Surgical treatment of painful DRU osteoarthritis with resection of distal ulna

  • Prosthesis

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: DarrachActive comparator 1 intervention
Group B: ProsthesisActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Norwegian version of Quick DASH (Quick Disability Arm Shoulder Hand) score

specific patient reported outcome measure, scale with range 0-100, with 0 defined as best possible and 100 as worst possible outcome

Time frame
at 5 years

Secondary outcomes

1

Norwegian vesrion of PRWHE (Patient Rated Wrist Hand Evaluation) score

Hand specific patient reported outcome measure, scale with range 0-100, with 0 defined as best and 100 as worst subjective outcome

Time frame
at 5 years
2

Visual Analogue Scale (VAS) pain scale

subjective evaluation of pain intensity, a scale with range 0-10 with 0 defined as best possible and 10 as worst outcome

Time frame
at 5 years
3

Active range of motion

objective measurement of movements in degrees, a scale with range 0-180 degrees.

Time frame
at 5 years
4

Grip strength

Measurement of grip strength of the hand, scale with range 0-100 kilograms

Time frame
at 5 years

Other outcomes

Sponsors and contacts

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