Rheumatoid ArthritisPhase 2/3NCT02336009
Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant
A Phase 2/3 study testing total wrist arthroplasty, Trimed in people with Rheumatoid Arthritis and Osteoarthritis, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
Total wrist arthroplasty (TWA) surgery has developed gradually and can offer patients with rheumatoid arthritis/osteoarthritis reduced wrist pain with mainly preserved wrist range of movement. Each year 60-70 patients in Sweden are operated with a total wrist arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis
- What is being tested?
- total wrist arthroplasty, Trimed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2014to Dec 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful wrist arthritis
- Wrightington X-ray grade 2-4.
Who cannot join
- Infection
- Substance abuse
- Mental illness.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Hand Surgery
Örebro, 70185
Kurt Pettersson, MD, PhD, 0046196025190, kurt.pettersson@orebroll.se
Marcus Sagerfors, MD, 0046196025507, marcus.sagerfors@orebroll.se
About this study
Official title: Clinical, Radiological and Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant
Total wrist arthroplasty (TWA) surgery has developed gradually and can offer patients with rheumatoid arthritis/osteoarthritis reduced wrist pain with mainly preserved wrist range of movement. Each year 60-70 patients in Sweden are operated with a total wrist arthroplasty. Several implants are available on the market and they all have different pros and cons. One risk with a total wrist arthroplasty is loosening of the implant. If an implant is loose, revision of the implant to another TWA is sometimes possible, if not, a wrist fusion is the likely alternative. Revision rates five years after the index operation have improved, however, they cannot yet compare with the results after a total hip arthroplasty. A newly designed TWA has been developed by the department of Hand Surgery, Örebro university Hospital, Örebro, Sweden, in cooperation with Trimed Inc. The newly developed TWA offers theoretical advantages and has been biomechanically tested at the Mayo clinic.
This is a pilot study where patients operated with the TWA will be assessed pre and postoperatively according to study protocol in order to evaluate outcome after TWA radiologically, clinically and regarding patient perceived outcome measures.
Read the detailed description
Method: Patients will be studied preoperatively and after 1, 2, 5, and 10 years with respect to changes of the following outcome measures.
- Patient related outcome measures: DASH=Disabilities of Arm Shoulder and Hand, COPM=Canadian Occupational Performance Measure, PRWE=Patient Related Wrist Evaluation.
- Wrist range of motion: dorsal/volar flexion, ulnar/radial deviation, pronation/supination. Hand grip strength, pinch grip, key pinch.
- Wrist pain. VAS-pain scores (Visual analog score) at rest and in activity.
- X-ray findings. Implant survival will be studied with Kaplan-Meyer graphs.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Being tested
- total wrist arthroplasty, Trimed
- Keywords
- wrist arthritis, total wrist arthroplasty
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total wrist arthroplasty, TrimedDevice
A new total wrist arthroplasty design. A pilot study.
| Study group | Role | What they receive |
|---|---|---|
| total wrist arthroplasty, Trimed | Experimental | This is a pilot study where all patients will be operated with the Trimed total wrist arthroplasty. Receives: Device: total wrist arthroplasty, Trimed |
What is being measured
The primary outcome is the main question the study is designed to answer.
revision rate
The frequency of TWA implants revised up to 10 years after the index operation
Measured: changes in revision rates up to 10 years postoperatively
Secondary outcomes (2)
changes in patient related outcome measures (PROM)
Assessed as DASH=Disabilities of Arm Shoulder and Hand, COPM=Canadian Occupational Performance Measure, PRWE=Patient Related Wrist Evaluation preoperatively and after 1, 2, 5, and 10 years postoperatively
Measured: 1, 2, 5, and 10 years postoperatively
Changes in Range of Motion (ROM
flexion, extension, radial and ulnar deviation, pronation, supination. Hand grip strength, pinch grip, lateral grip, and radiographic loosening, VAS-pain scores.
Measured: 1, 2, 5, and 10 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro Läns Landsting
- Responsible party
- Principal investigator, Anil Gupta, Örebro University, Sweden
- Investigators
- Kurt Pettersson, MD, PhD, Principal investigator, Orebro County Council, Orebro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336009
- Sponsor's protocol ID
- Orebro Lans landsting 01-14
- Status last verified
- Aug 2018
- First submitted
- 24 Nov 2014
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiological and Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant
- ClinicalTrials.gov ID
- NCT02336009
- Acronym / sponsor ID
- Orebro Lans landsting 01-14
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Keywords
- wrist arthritis, total wrist arthroplasty
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Örebro Läns Landsting
- Study start
- Oct 2014
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Jan 2015 (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.
Total wrist arthroplasty (TWA) surgery has developed gradually and can offer patients with rheumatoid arthritis/osteoarthritis reduced wrist pain with mainly preserved wrist range of movement. Each year 60-70 patients in Sweden are operated with a total wrist arthroplasty. Several implants are available on the market and they all have different pros and cons. One risk with a total wrist arthroplasty is loosening of the implant. If an implant is loose, revision of the implant to another TWA is sometimes possible, if not, a wrist fusion is the likely alternative. Revision rates five years after the index operation have improved, however, they cannot yet compare with the results after a total hip arthroplasty. A newly designed TWA has been developed by the department of Hand Surgery, Örebro university Hospital, Örebro, Sweden, in cooperation with Trimed Inc. The newly developed TWA offers theoretical advantages and has been biomechanically tested at the Mayo clinic.
This is a pilot study where patients operated with the TWA will be assessed pre and postoperatively according to study protocol in order to evaluate outcome after TWA radiologically, clinically and regarding patient perceived outcome measures.
Detailed description
Method: Patients will be studied preoperatively and after 1, 2, 5, and 10 years with respect to changes of the following outcome measures.
- Patient related outcome measures: DASH=Disabilities of Arm Shoulder and Hand, COPM=Canadian Occupational Performance Measure, PRWE=Patient Related Wrist Evaluation.
- Wrist range of motion: dorsal/volar flexion, ulnar/radial deviation, pronation/supination. Hand grip strength, pinch grip, key pinch.
- Wrist pain. VAS-pain scores (Visual analog score) at rest and in activity.
- X-ray findings. Implant survival will be studied with Kaplan-Meyer graphs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| total wrist arthroplasty, Trimed | Experimental | Device: total wrist arthroplasty, TrimedThis is a pilot study where all patients will be operated with the Trimed total wrist arthroplasty. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Painful wrist arthritis
- Wrightington X-ray grade 2-4.
Key exclusion criteria (3 listed)
- Infection
- Substance abuse
- Mental illness.
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 |
|---|---|---|
| total wrist arthroplasty, TrimedA new total wrist arthroplasty design. A pilot study. | Device | total wrist arthroplasty, Trimed |
Primary outcome
revision rate
Time frame: changes in revision rates up to 10 years postoperatively
The frequency of TWA implants revised up to 10 years after the index operation
2 secondary outcomes
changes in patient related outcome measures (PROM)
Time frame: 1, 2, 5, and 10 years postoperatively
Changes in Range of Motion (ROM
Time frame: 1, 2, 5, and 10 years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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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. This study is not recruiting at the moment.
Kurt Pettersson, MD, PhD principal investigator
Orebro County Council, Orebro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing total wrist arthroplasty, Trimed in people with Rheumatoid Arthritis and Osteoarthritis, run by Örebro University, Sweden at 1 site in Sweden.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Aug 2018. 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 Sweden. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kurt Pettersson, MD, PhD (0046196025190, kurt.pettersson@orebroll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
revision rate (time frame: changes in revision rates up to 10 years postoperatively). 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 29 Aug 2018.