Norwegian Distal Ulna Resection - Replacement Study (NORDURR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis Wrist
• Intervention / Treatment: Procedure: Darrach; Procedure: Prosthesis

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Istvan Zoltan Rigo, PhD; Phone Number: +47 69860000; Email: istvan.zoltan.rigo@so-hf.no
• Study Contact Backup: Name: Jan-Ragnar Haugstvedt, PhD; Phone Number: +47 69860000; Email: Jan-Ragnar.Haugstvedt@so-hf.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Not yet recruiting
    • Haukeland University Hospital
    • Contact: Eivind Strandenes, MD; Phone Number: 55972771; Email: eivind.strandenes@helse-bergen.no
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo University Hospital
    • Contact: Magne Røkkum, PhD, Prof; Phone Number: +4723070000; Email: mrokkum@ous-hf.no
    • Contact: Sondre Hasselllund, MD; Phone Number: +4722118080; Email: sondre.hassellund@gmail.com
  • Tromsø, Norway, 9038
    • Not yet recruiting
    • University Hospital of North Norway
    • Contact: Hebe Desiree Kvernmo, PhD, Prof; Phone Number: 776 26000; Email: hebe.kvernmo@gmail.com
  • Trondheim, Norway, 7006
    • Not yet recruiting
    • University Hospital of St Olav
    • Contact: Heike Brigitta Zeitlemann, MD; Phone Number: +4772826000; Email: heike.zeitlmann@stolav.no
  • Oppland
    • Lillehammer, Oppland, Norway, 2629
      • Not yet recruiting
      • Innlandet Hospital Trust
      • Contact: Ole Anton Kragh Fosse, MD; Phone Number: 915 06 200; Email: ole.a.k.fosse@sykehuset-innlandet.no
  • Østfold
    • Moss, Østfold, Norway, 1535
      • Recruiting
      • Østfold Hospital Trust
      • Contact: Istvan Zoltan Rigo, PhD; Phone Number: +4769860000; Email: istvan.zoltan.rigo@so-hf.no
      • Contact: Jan-Ragnar Haugstvedt, PhD; Phone Number: +4769860000; Email: jan-ragnar.haugstvedt@so-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Darrach; Surgical procedure: resection of distal ulna	Procedure: Darrach; Surgical treatment of painful DRU osteoarthritis with resection of distal ulna; Other Names: resection of ulnar head (Darrach procedure)
Active Comparator: Prosthesis; Surgical procedure: ulnar head replacement	Procedure: Prosthesis; Surgical treatment of painful DRU osteoarthritis with distal ulna replacement with Herbert implant; Other Names: Herbert disltal ulna implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Investigators: Principal Investigator: Istvan Zoltan Rigo, PhD, Ostfold Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Distal radioulnar joint; Darrach procedure; Ulnar head resection; Herbert prosthesis; Ulnar head replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: OstfoldHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No