Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis
NCT ID: NCT04455763
Last Updated: 2021-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-01-14
2023-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints
NCT03166410
Treatment of Osteoarthritis With the Stromal Vascular Fraction of Abdominal Adipose Tissue - a Pilot Study
NCT02697682
Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
NCT05005000
Micro-fragmented Adipose Tissue Injection Associated With Arthroscopic Procedures in Patients With Knee Osteoarthritis
NCT03527693
Allograft Meniscal Arthroplasty for the Treatment of Basal Joint Arthritis of the Thumb
NCT01542515
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SVF
Thumb carpometacarpal injection with adipose-derived SVF combined with splinting
SVF
Adipose-derived stromal vascular fraction
Splint
Thumb brace (Actimove® Rhizo Forte)
Splint
Thumb carpometacarpal osteoarthrosis treated with splinting only
Splint
Thumb brace (Actimove® Rhizo Forte)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SVF
Adipose-derived stromal vascular fraction
Splint
Thumb brace (Actimove® Rhizo Forte)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
40 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Helsinki University Central Hospital
OTHER
Töölö Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Samuli Aspinen
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Samuli Aspinen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
HUS Töölö Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Töölö Hospital (Helsinki University Hospital)
Helsinki, , Finland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1866/2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.