Norwegian Distal Ulna Resection - Replacement Study

NCT04074863 | Recruiting

• 1 other identifier: OstfoldHT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Distal radioulnar joint; Darrach procedure; Ulnar head resection; Herbert prosthesis; Ulnar head replacement

Outcome Measures

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

  at 5 years

Secondary Outcomes (5)

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

  at 5 years

• Visual Analogue Scale (VAS) pain scale

  at 5 years

• Active range of motion

  at 5 years

• Grip strength

  at 5 years

• complications and reoperations

  at 5 years

Study Arms (2)

Darrach

ACTIVE COMPARATOR

Surgical procedure: resection of distal ulna

Procedure: Darrach

Prosthesis

ACTIVE COMPARATOR

Surgical procedure: ulnar head replacement

Procedure: Prosthesis

Interventions

Darrach PROCEDURE

Surgical treatment of painful DRU osteoarthritis with resection of distal ulna

Also known as: resection of ulnar head (Darrach procedure)

Darrach

Prosthesis PROCEDURE

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

Also known as: Herbert disltal ulna implant

Prosthesis

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• painful osteoarthritis distal radioulnar joint
• stable DRUJ

You may not qualify if:

• 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

Sponsors & Collaborators

• Ostfold Hospital Trust: lead

Study Sites (6)

Innlandet Hospital Trust

Lillehammer, Oppland, 2629, Norway

NOT YET RECRUITING

Haukeland University Hospital

Bergen, 5021, Norway

NOT YET RECRUITING

Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

University Hospital of North Norway

Tromsø, 9038, Norway

NOT YET RECRUITING

University Hospital of St Olav

Trondheim, 7006, Norway

NOT YET RECRUITING

Østfold Hospital Trust

Moss, Østfold fylke, 1535, Norway

RECRUITING

MeSH Terms

Interventions

Prostheses and Implants

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Istvan Zoltan Rigo, PhD

  Ostfold Hospital Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Istvan Zoltan Rigo, PhD

CONTACT

+47 69860000; istvan.zoltan.rigo@so-hf.no

Jan-Ragnar Haugstvedt, PhD

CONTACT

+47 69860000; Jan-Ragnar.Haugstvedt@so-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent hand therapist, who is not involved in the rehabilitation of the participants, will carry out the measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: Participants randomized to one of the group and receive the group specific surgery. Postoperative treatment is identical between the groups.

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: August 30, 2019
• Study Start: September 16, 2020
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (6)