Thumb OsteoarthritisREMEDY SVFNCT04455763
Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis
A study testing SVF and Splint in people with Thumb Osteoarthritis, run by Töölö Hospital at 1 site in Finland.
Trial summary
Trial purpose is to research the outcome after thumb carpometacarpal injection with stromal vascular fraction (SVF) derived from adipose tissue. The study compares SVF injection therapy with thumb splinting vs. splinting only. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- SVF and Splint
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 14 Jan 2021to Mar 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-70 years
- Eaton-Glickel II thumb CMC osteoarthrosis
- Symptom duration > 3 months
- Pain visual analogue score > 30 mm
- < 3 months of treatment with thumb splinting
- American Society of Anaesthesiologists physical status (ASA) I-III
- Fluent in written and spoken Finnish
Who cannot join
- Age <40 or >70 years
- Eaton-Glickel I, III-IV
- Symptom duration < 3 months
- Pain VAS < 30 mm
- Post-traumatic osteoarthrosis of thumb CMC I
- Rheumatoid arthritis or other inflammatory joint disease
Show all 15Show fewer
- The use of per oral corticosteroids or other immunomodulatory drugs
- Less than 6 months after another operation of the same upper limb
- Other condition of the same upper limb requiring surgery
- Malnutrition
- Neurological condition affecting upper limb function
- Heavy smoking (> 20 cigarettes per day)
- Alcohol or drug abuse
- Previous history or active cancer
- Previous history of allergic reaction to local anaesthetic
Trial locations and contacts
1 site in 1 country.
Jussi Kosola, M.D., Ph.D. contact
Finland1 site, 1 recruiting
- Recruiting
Töölö Hospital (Helsinki University Hospital)
Helsinki
Samuli Aspinen, M.D., Ph.D., +358406360546, samuli.aspinen@hus.fi
Jorma Ryhänen, adj. prof, jorma.ryhanen@hus.fi
About this study
Official title: Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis - ReMeDY SVF -Trial
Trial purpose is to research the outcome after thumb carpometacarpal injection with stromal vascular fraction (SVF) derived from adipose tissue. The study compares SVF injection therapy with thumb splinting vs. splinting only.
Patients with radiologically and clinically confirmed Eaton-Glickel II osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo SVF injection and splinting vs. splinting only.
Baseline data is collected preoperatively and patients are followed at 1, 3 and 6 months after enrollment. The primary end-point is 6 months and the primary outcome is pain visual analogue scale and patient-rated wrist evaluation (PRWE).
- Conditions
- Thumb Osteoarthritis
- Being tested
- SVF, Splint
- Keywords
- Thumb Osteoarthrosis, Stromal Vascular Fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVFProcedure or surgery
Adipose-derived stromal vascular fraction
SplintOther
Thumb brace (Actimove® Rhizo Forte)
| Study group | Role | What they receive |
|---|---|---|
| SVF | Experimental | Thumb carpometacarpal injection with adipose-derived SVF combined with splinting Receives: Procedure: SVF; Other: Splint |
| Splint | Active comparator | Thumb carpometacarpal osteoarthrosis treated with splinting only Receives: Other: Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (Visual Analogue Scale)
The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)
Measured: 6 months
Patient-Rated Wrist Evaluation (PRWE)
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: 6 months
Secondary outcomes (5)
Global improvement
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: 6 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: 6 months
Key pinch strength
Key pinch 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: 6 months
Michigan Hand Outcomes Questionnaire (MHQ)
The MHQ comprises of 37 core questions to measure hand-specific outcomes containing six distinct scales: overall hand function, activities of daily living, pain, work performance, aesthetics and patient satisfaction with hand function.
Measured: 6 months
Complications
Incidence of complications (hemaetoma, injection site infection etc.)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start14 Jan 2021
- Primary completionSep 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb OsteoarthritisStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Töölö Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Principal investigator, Samuli Aspinen, Töölö Hospital
- Investigators
- Samuli Aspinen, M.D., Ph.D., Principal investigator, HUS Töölö Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455763
- Sponsor's protocol ID
- 1866/2020
- Acronym
- REMEDY SVF
- Status last verified
- Jan 2021
- First submitted
- 28 Jun 2020
- Last updated
- 19 Jan 2021
- 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 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis - ReMeDY SVF -Trial
- ClinicalTrials.gov ID
- NCT04455763
- Acronym / sponsor ID
- REMEDY SVF / 1866/2020
- Conditions
- Thumb Osteoarthritis
- Keywords
- Thumb Osteoarthrosis, Stromal Vascular Fraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Töölö HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 2 Jul 2020 (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.
Trial purpose is to research the outcome after thumb carpometacarpal injection with stromal vascular fraction (SVF) derived from adipose tissue. The study compares SVF injection therapy with thumb splinting vs. splinting only.
Patients with radiologically and clinically confirmed Eaton-Glickel II osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo SVF injection and splinting vs. splinting only.
Baseline data is collected preoperatively and patients are followed at 1, 3 and 6 months after enrollment. The primary end-point is 6 months and the primary outcome is pain visual analogue scale and patient-rated wrist evaluation (PRWE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVF | Experimental | Procedure: SVF, Other: SplintThumb carpometacarpal injection with adipose-derived SVF combined with splinting |
| Splint | Active comparator | Other: SplintThumb carpometacarpal osteoarthrosis treated with splinting only |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40-70 years
- Eaton-Glickel II thumb CMC osteoarthrosis
- Symptom duration > 3 months
- Pain visual analogue score > 30 mm
- < 3 months of treatment with thumb splinting
Key exclusion criteria (15 listed)
- Age <40 or >70 years
- Eaton-Glickel I, III-IV
- Symptom duration < 3 months
- Pain VAS < 30 mm
- Post-traumatic osteoarthrosis of thumb CMC I
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 |
|---|---|---|
| SVFAdipose-derived stromal vascular fraction | Procedure or surgery | SVF |
| SplintThumb brace (Actimove® Rhizo Forte) | Other | SVF, Splint |
Primary outcome
Pain (Visual Analogue Scale)
Time frame: 6 months
The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)
Patient-Rated Wrist Evaluation (PRWE)
Time frame: 6 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)
5 secondary outcomes
Global improvement
Time frame: 6 months
Grip strength
Time frame: 6 months
Key pinch strength
Time frame: 6 months
Michigan Hand Outcomes Questionnaire (MHQ)
Time frame: 6 months
Complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Thumb Osteoarthritis
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Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
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Not yet recruitingObservational study
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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.
Jussi Kosola, M.D., Ph.D. contact
Samuli Aspinen, M.D., Ph.D. principal investigator
HUS Töölö 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 SVF and Splint in people with 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 7 inclusion and 15 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 19 Jan 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?
Pain (Visual Analogue Scale) (time frame: 6 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 19 Jan 2021.