Norwegian Distal Ulna Resection - Replacement Study

Osteoarthritis Wrist Clinical Trial

— NORDURR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04074863
• Other study ID #: OstfoldHT
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: Ostfold Hospital Trust
• Contact: Istvan Zoltan Rigo, PhD
• Phone: +47 69860000
• Email: istvan.zoltan.rigo[@]so-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Wrist

Intervention

Procedure:
• Darrach
Surgical treatment of painful DRU osteoarthritis with resection of distal ulna
• Prosthesis
Surgical treatment of painful DRU osteoarthritis with distal ulna replacement with Herbert implant

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Innlandet Hospital Trust	Lillehammer	Oppland
Norway	Østfold Hospital Trust	Moss	Østfold
Norway	Oslo University Hospital	Oslo
Norway	University Hospital of North Norway	Tromsø
Norway	University Hospital of St Olav	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	at 5 years
Secondary	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	at 5 years
Secondary	Active range of motion	objective measurement of movements in degrees, a scale with range 0-180 degrees.	at 5 years
Secondary	Grip strength	Measurement of grip strength of the hand, scale with range 0-100 kilograms	at 5 years
Secondary	complications and reoperations	Registration of occurance of any adverse event, will be reported as number of participants with complications and reoperations	at 5 years