ArthritisNCT04826380
Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Cinematics and Cost-utility
A study testing Trapeziectomy in people with Arthritis and Thumb Osteoarthritis, run by Töölö Hospital at 1 site in Finland.
Trial summary
A project aiming to promote evidence based practice when treating thumb basal joint (CMC I) arthritis. We will aim to: 1) provide the minimal clinical difference of two general outcome instruments, 2) evaluate the association between pre-operative anxiety and/or depression and outcomes following trapeziectomy, 3)… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Arthritis, Thumb Osteoarthritis, Arthropathy
- What is being tested?
- Trapeziectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- 29 Mar 2021to 1 Apr 2025
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eaton-Glickel >2 arhritis
- Symptom duration >3 months
- Pain VAS >30mm
- No significant comorbidities, ASA I-II
- Fluent in Finnish language
Who cannot join
- Eaton-Glickel <2
- Duration of symptoms <3 months
- VAS <30mm
- ASA >II
- Inflammatory joint disease
- Systemic corticosteroid or immunomodulatory medication
Show all 11Show fewer
- Upper limb symptoms not explained with CMC I artritis
- Heavy smoking (> 20 cigarettes per day)
- Alcohol or drug abuse
- Neurological condition affecting upper limb function
- Other ipsilateral upper limb condition requiring surgery
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Töölö Hospital (Helsinki University Hospital)
Helsinki
Samuli Aspinen, M.D., Ph.D., +358406360546, samuli.aspinen@hus.fi
About this study
Official title: Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Kinematics and Cost-utility
A project aiming to promote evidence based practice when treating thumb basal joint (CMC I) arthritis. We will aim to: 1) provide the minimal clinical difference of two general outcome instruments, 2) evaluate the association between pre-operative anxiety and/or depression and outcomes following trapeziectomy, 3) evaluate the effect of trapziectomy on carpal cinematics, 4) determine the cost-utility-ratio of trapeziectomy
- Conditions
- Arthritis, Thumb Osteoarthritis, Arthropathy, Quality of Life
- Being tested
- Trapeziectomy
- Medical subject headings
- Arthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrapeziectomyProcedure or surgery
Simple trapeziectomy (without LRTI)
| Study group | Role | What they receive |
|---|---|---|
| Trapeziectomy | Other | Simple trapeziectomy for treating CMC I arthritis Receives: Procedure: Trapeziectomy |
| Conservative | No intervention | Conservative measures (e.g. splint, NSAID, activation modification) for treating CMC I arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated Wrist Evaluation
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
Measured: 12 months
Michigan Hand Outcome Questionnaire
A hand-specific outcomes instrument that contains six distinct scales: (1) overall hand function, (2) activities of daily living, (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with hand function.
Measured: 12 months
Secondary outcomes (8)
Pain Catastrophizing Scale
A pain catastrophizing scale comprising of three subscales: (1) Helplessness, (2) Rumination, and (3) Magnification
Measured: 12 months
Pain (Visual Analogue Scale)
The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain)
Measured: 12 months
Global improvemen
Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better
Measured: 12 months
Grip strength
Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side
Measured: 12 months
Wrist and hand (thumb) range of motion (ROM)
ROM is measured on both hands with a handheld goniometer in degrees.
Measured: 12 months
Cost-utility
Quality-adjusted life years/months measured as a change in EQ-5D
Measured: 12 months
Carpal Kinematics
Evaluated from preoperative and compared to 1-year postoperative 4-dimension cone-beam tomography - the wrists are imaged in 7 different postures to reproduce carpal movement, the pre and postoperative scans will be compared to evalueate the effect of trapeziectomy on carpal kinematics (e.g. scapholunate angle, lunotriquetral angle, metacarpal subsidence)
Measured: 12 months
Beck Depression Inventory
21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start29 Mar 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Töölö Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuli Aspinen, Töölö Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826380
- Sponsor's protocol ID
- 3163/2020
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and analyzed during this trial will be available from the PI on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Kinematics and Cost-utility
- ClinicalTrials.gov ID
- NCT04826380
- Acronym / sponsor ID
- 3163/2020
- Conditions
- Arthritis, Thumb Osteoarthritis, Arthropathy, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Töölö HospitalUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 1 Apr 2021 (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.
A project aiming to promote evidence based practice when treating thumb basal joint (CMC I) arthritis. We will aim to: 1) provide the minimal clinical difference of two general outcome instruments, 2) evaluate the association between pre-operative anxiety and/or depression and outcomes following trapeziectomy, 3) evaluate the effect of trapziectomy on carpal cinematics, 4) determine the cost-utility-ratio of trapeziectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trapeziectomy | Other | Procedure: TrapeziectomySimple trapeziectomy for treating CMC I arthritis |
| Conservative | No intervention | –Conservative measures (e.g. splint, NSAID, activation modification) for treating CMC I arthritis |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eaton-Glickel >2 arhritis
- Symptom duration >3 months
- Pain VAS >30mm
- No significant comorbidities, ASA I-II
- Fluent in Finnish language
Key exclusion criteria (11 listed)
- Eaton-Glickel <2
- Duration of symptoms <3 months
- VAS <30mm
- ASA >II
- Inflammatory joint disease
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 |
|---|---|---|
| TrapeziectomySimple trapeziectomy (without LRTI) | Procedure or surgery | Trapeziectomy |
Primary outcome
Patient-Rated Wrist Evaluation
Time frame: 12 months
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
Michigan Hand Outcome Questionnaire
Time frame: 12 months
A hand-specific outcomes instrument that contains six distinct scales: (1) overall hand function, (2) activities of daily living, (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with hand function.
8 secondary outcomes
Pain Catastrophizing Scale
Time frame: 12 months
Pain (Visual Analogue Scale)
Time frame: 12 months
Global improvemen
Time frame: 12 months
Grip strength
Time frame: 12 months
Wrist and hand (thumb) range of motion (ROM)
Time frame: 12 months
Cost-utility
Time frame: 12 months
Carpal Kinematics
Time frame: 12 months
Beck Depression Inventory
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Individual participant dataSharing planned: Yes. The datasets generated and analyzed during this trial will be available from the PI on reasonable request.
Related trials for Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trapeziectomy in people with Arthritis and Thumb Osteoarthritis, run by Töölö Hospital at 1 site in Finland.
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 5 inclusion and 11 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 2 Apr 2021. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuli Aspinen, M.D., Ph.D. (+358406360546, samuli.aspinen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Rated Wrist Evaluation (time frame: 12 months). The study lists 2 primary outcomes in all. 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 2 Apr 2021.