Norwegian Distal Ulna Resection - Replacement Study

NCT ID: NCT04074863

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-16
• Study Completion Date: 2029-12-31

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.

Detailed Description

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. The study would be coordinated from Østfold Hospital Trust, and Oslo University Hospital, Haukeland University Hospital, Innlandet Hospital Trust, University Hospital of St Olav and University Hospital of North Norway would participate this study.

Participants would be included among individuals seeking treatment for their stable but painful DRUJ joints. Informed consent will be gained from every participant. The group size was calculated to 20 participants in both groups.

Participants will be randomized to either Darrach procedure or ulnar head implant. The procedures would be carried out standardized in every center. No further stabilization procedure for the ulna stump would be used in resection. Herbert UHP implant (Herbert Ulnar Head Prosthesis, KLS Martin, Germany) would be used for ulnar head replacement. Postoperative treatment and follow up would be identical between the groups.

Range of motion and grip strength measures and functional scores would be registered by an independent hand therapist before operation, after 3 months, 1 and 5 years. Eventual complications and reoperations would be also registered.

Patient related outcome measure scores, range of motion and grip strength would be registered as outcomes. The results would be checked for normal distribution and either parametric or non parametric statistical tests would be chosen for comparison of the two groups.

The null hypothesis is that Darrach procedure and ulnar head replacement with implant gives similar functional results, similar frequency of complication and reoperations.

Conditions

Osteoarthritis Wrist

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Darrach

Surgical procedure: resection of distal ulna

Group Type: ACTIVE_COMPARATOR

Darrach

Intervention Type: PROCEDURE

Surgical treatment of painful DRU osteoarthritis with resection of distal ulna

Prosthesis

Surgical procedure: ulnar head replacement

Group Type: ACTIVE_COMPARATOR

Prosthesis

Intervention Type: PROCEDURE

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

Interventions

Darrach

Surgical treatment of painful DRU osteoarthritis with resection of distal ulna

Intervention Type: PROCEDURE

Prosthesis

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

Intervention Type: PROCEDURE

Other Intervention Names

resection of ulnar head (Darrach procedure); Herbert disltal ulna implant

Eligibility Criteria

Inclusion Criteria

• painful osteoarthritis distal radioulnar joint
• stable DRUJ

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ostfold Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Istvan Zoltan Rigo

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Istvan Zoltan Rigo, PhD

Role: PRINCIPAL_INVESTIGATOR

Ostfold Hospital Trust

Locations

Innlandet Hospital Trust

Lillehammer, Oppland, Norway

Site Status: NOT_YET_RECRUITING

Haukeland University Hospital

Bergen, , Norway

Site Status: NOT_YET_RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

University Hospital of North Norway

Tromsø, , Norway

Site Status: NOT_YET_RECRUITING

University Hospital of St Olav

Trondheim, , Norway

Site Status: NOT_YET_RECRUITING

Østfold Hospital Trust

Moss, Østfold fylke, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Istvan Zoltan Rigo, PhD

Role: CONTACT

istvan.zoltan.rigo@so-hf.no

+47 69860000

Jan-Ragnar Haugstvedt, PhD

Role: CONTACT

Jan-Ragnar.Haugstvedt@so-hf.no

+47 69860000

Facility Contacts

Ole Anton Kragh Fosse, MD

Role: primary

ole.a.k.fosse@sykehuset-innlandet.no

915 06 200

Eivind Strandenes, MD

Role: primary

eivind.strandenes@helse-bergen.no

55972771

Magne Røkkum, PhD, Prof

Role: primary

mrokkum@ous-hf.no

+4723070000

Sondre Hasselllund, MD

Role: backup

sondre.hassellund@gmail.com

+4722118080

Hebe Desiree Kvernmo, PhD, Prof

Role: primary

hebe.kvernmo@gmail.com

776 26000

Heike Brigitta Zeitlemann, MD

Role: primary

heike.zeitlmann@stolav.no

+4772826000

Istvan Zoltan Rigo, PhD

Role: primary

istvan.zoltan.rigo@so-hf.no

+4769860000

Jan-Ragnar Haugstvedt, PhD

Role: backup

jan-ragnar.haugstvedt@so-hf.no

+4769860000

Other Identifiers

OstfoldHT

Identifier Type: -

Identifier Source: org_study_id