Osteoarthritis WristNORDURRNCT04074863
Norwegian Distal Ulna Resection - Replacement Study
A study testing Darrach and Prosthesis in people with Osteoarthritis Wrist, run by Ostfold Hospital Trust at 6 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Osteoarthritis Wrist
- What is being tested?
- Darrach and Prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesNorway
- Study dates
- 16 Sep 2020to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- painful osteoarthritis distal radioulnar joint
- stable DRUJ
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Norway6 sites, 6 recruiting
- Not yet recruiting
Haukeland University Hospital
Bergen, 5021
Eivind Strandenes, MD, 55972771, eivind.strandenes@helse-bergen.no
- Not yet recruiting
Innlandet Hospital Trust
Lillehammer, Oppland, 2629
Ole Anton Kragh Fosse, MD, 915 06 200, ole.a.k.fosse@sykehuset-innlandet.no
- Recruiting
Østfold Hospital Trust
Moss, Østfold fylke, 1535
Istvan Zoltan Rigo, PhD, +4769860000, istvan.zoltan.rigo@so-hf.no
Jan-Ragnar Haugstvedt, PhD, +4769860000, jan-ragnar.haugstvedt@so-hf.no
- Recruiting
Oslo University Hospital
Oslo, 0424
Magne Røkkum, PhD, Prof, +4723070000, mrokkum@ous-hf.no
Sondre Hasselllund, MD, +4722118080, sondre.hassellund@gmail.com
- Not yet recruiting
University Hospital of North Norway
Tromsø, 9038
Hebe Desiree Kvernmo, PhD, Prof, 776 26000, hebe.kvernmo@gmail.com
- Not yet recruiting
University Hospital of St Olav
Trondheim, 7006
Heike Brigitta Zeitlemann, MD, +4772826000, heike.zeitlmann@stolav.no
About this study
Official title: 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.
Read the 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
- Being tested
- Darrach, Prosthesis
- Keywords
- Distal radioulnar joint, Darrach procedure, Ulnar head resection, Herbert prosthesis, Ulnar head replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarrachProcedure or surgery
Also called resection of ulnar head (Darrach procedure)
Surgical treatment of painful DRU osteoarthritis with resection of distal ulna
ProsthesisProcedure or surgery
Also called Herbert disltal ulna implant
Surgical treatment of painful DRU osteoarthritis with distal ulna replacement with Herbert implant
| Study group | Role | What they receive |
|---|---|---|
| Darrach | Active comparator | Surgical procedure: resection of distal ulna Receives: Procedure: Darrach |
| Prosthesis | Active comparator | Surgical procedure: ulnar head replacement Receives: Procedure: Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 5 years
Secondary outcomes (5)
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
Measured: 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
Measured: at 5 years
Active range of motion
objective measurement of movements in degrees, a scale with range 0-180 degrees.
Measured: at 5 years
Grip strength
Measurement of grip strength of the hand, scale with range 0-100 kilograms
Measured: at 5 years
complications and reoperations
Registration of occurance of any adverse event, will be reported as number of participants with complications and reoperations
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start16 Sep 2020
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis WristStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to one of the group and receive the group specific surgery. Postoperative treatment is identical between the groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Istvan Zoltan Rigo, Ostfold Hospital Trust
- Investigators
- Istvan Zoltan Rigo, PhD, Principal investigator, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074863
- Sponsor's protocol ID
- OstfoldHT
- Acronym
- NORDURR
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2019
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Distal Ulna Resection vs. Replacement Study. A Prospective Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT04074863
- Acronym / sponsor ID
- NORDURR / OstfoldHT
- Conditions
- Osteoarthritis Wrist
- Keywords
- Distal radioulnar joint, Darrach procedure, Ulnar head resection, Herbert prosthesis, Ulnar head replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants randomized to one of the group and receive the group specific surgery. Postoperative treatment is identical between the groups.
| Arm | Type | Receives |
|---|---|---|
| Darrach | Active comparator | Procedure: DarrachSurgical procedure: resection of distal ulna |
| Prosthesis | Active comparator | Procedure: ProsthesisSurgical procedure: ulnar head replacement |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- painful osteoarthritis distal radioulnar joint
- stable DRUJ
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarrachAlso: resection of ulnar head (Darrach procedure)Surgical treatment of painful DRU osteoarthritis with resection of distal ulna | Procedure or surgery | Darrach |
| ProsthesisAlso: Herbert disltal ulna implantSurgical treatment of painful DRU osteoarthritis with distal ulna replacement with Herbert implant | Procedure or surgery | Prosthesis |
Primary outcome
Norwegian version of Quick DASH (Quick Disability Arm Shoulder Hand) score
Time frame: at 5 years
specific patient reported outcome measure, scale with range 0-100, with 0 defined as best possible and 100 as worst possible outcome
5 secondary outcomes
Norwegian vesrion of PRWHE (Patient Rated Wrist Hand Evaluation) score
Time frame: at 5 years
Visual Analogue Scale (VAS) pain scale
Time frame: at 5 years
Active range of motion
Time frame: at 5 years
Grip strength
Time frame: at 5 years
complications and reoperations
Time frame: at 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Istvan Zoltan Rigo, PhD principal investigator
Ostfold Hospital Trust
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Darrach and Prosthesis in people with Osteoarthritis Wrist, run by Ostfold Hospital Trust at 6 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Istvan Zoltan Rigo, PhD (+47 69860000, istvan.zoltan.rigo@so-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Norwegian version of Quick DASH (Quick Disability Arm Shoulder Hand) score (time frame: at 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.