Non-rheumatoid Wrist ArthritisNCT01842724
Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Study
A study testing Motec total wrist arthroplasty and Remotion total wrist arthroplasty in people with Non-rheumatoid Wrist Arthritis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine the difference in the results between Motec and Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-rheumatoid Wrist Arthritis
- What is being tested?
- Motec total wrist arthroplasty and Remotion total wrist arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2014to Nov 2034
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients with painful non-rheumatoid wrist arthritis (posttraumatic arthritis and late stage Kienboeck's disease)
- Age 18-70 years
- ASA class 1-3
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Randomized Study.
The purpose of this study is to determine the difference in the results between Motec and Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.
- Conditions
- Non-rheumatoid Wrist Arthritis
- Being tested
- Motec total wrist arthroplasty, Remotion total wrist arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motec total wrist arthroplastyProcedure or surgery
Remotion total wrist arthroplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Motec total wrist arthroplasty | Active comparator | Not described Receives: Procedure: Motec total wrist arthroplasty |
| Remotion total wrist arthroplasty | Active comparator | Not described Receives: Procedure: Remotion total wrist arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRWHE (Patient rated Wrist and Hand Evaluation score)
PRWHE is a wrist specific patient assessed questionnaire, measuring pain, wrist specific function and general function
Measured: 24 months postop
Secondary outcomes (10)
Wrist movement
Overall degree of flexion, extension, radial and ulnar deviation
Measured: 24 months postop
Grip Strength
Measured: 24 months postop
Pain in affected wrist
Visual analogue scale
Measured: 24 months postop
Quick-DASH
"Disabilities of the Arm, Shoulder and Hand" questionnaire
Measured: 24 months postop
intraoperative complications
Measured: intraoperative
Postoperative complications
Measured: 24 months postop
Implant loosening
Implant loosening seen on x-ray
Measured: 24 months postop
Implant migration
Implant migration seen on model-based roentgen stereophotogrammetric analysis (RSA), as a possible precursor of later implant loosening
Measured: 24 months postop
Periprosthetic bone mineral density
BMD measured with DEXA (dual-energy x-ray absorptiometry)
Measured: 24 months postop
Reoperations
Reoperations of any cause
Measured: 24 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startAug 2014
- Primary completionNov 2034 (estimated)
- Study completionNov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-rheumatoid Wrist ArthritisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trygve Holm Glad, Oslo University Hospital
- Investigators
- Trygve Holm Glad, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842724
- Sponsor's protocol ID
- 2013/149
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2013
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT01842724
- Acronym / sponsor ID
- 2013/149
- Conditions
- Non-rheumatoid Wrist Arthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2034 (estimated)
- Study completion
- Nov 2034 (estimated)
- First posted
- 30 Apr 2013 (estimated)
- 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.
The purpose of this study is to determine the difference in the results between Motec and Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motec total wrist arthroplasty | Active comparator | Procedure: Motec total wrist arthroplasty |
| Remotion total wrist arthroplasty | Active comparator | Procedure: Remotion total wrist arthroplasty |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with painful non-rheumatoid wrist arthritis (posttraumatic arthritis and late stage Kienboeck's disease)
- Age 18-70 years
- ASA class 1-3
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Motec total wrist arthroplasty | Procedure or surgery | Motec total wrist arthroplasty |
| Remotion total wrist arthroplasty | Procedure or surgery | Remotion total wrist arthroplasty |
Primary outcome
PRWHE (Patient rated Wrist and Hand Evaluation score)
Time frame: 24 months postop
PRWHE is a wrist specific patient assessed questionnaire, measuring pain, wrist specific function and general function
10 secondary outcomes
Wrist movement
Time frame: 24 months postop
Grip Strength
Time frame: 24 months postop
Pain in affected wrist
Time frame: 24 months postop
Quick-DASH
Time frame: 24 months postop
intraoperative complications
Time frame: intraoperative
Postoperative complications
Time frame: 24 months postop
Implant loosening
Time frame: 24 months postop
Implant migration
Time frame: 24 months postop
Periprosthetic bone mineral density
Time frame: 24 months postop
Reoperations
Time frame: 24 months postop
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 28 Feb 2024.
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. This study is not recruiting at the moment.
Trygve Holm Glad, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motec total wrist arthroplasty and Remotion total wrist arthroplasty in people with Non-rheumatoid Wrist Arthritis, run by Oslo University Hospital at 1 site 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 3 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRWHE (Patient rated Wrist and Hand Evaluation score) (time frame: 24 months postop). 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 28 Feb 2024.