Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis

Thumb Osteoarthritis Clinical Trial

— REMEDY SVF  

Official title:

Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis - ReMeDY SVF -Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04455763
• Other study ID #: 1866/2020
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: March 2023

Study information

• Verified date: January 2021
• Source: Töölö Hospital
• Contact: Samuli Aspinen, M.D., Ph.D.
• Phone: +358406360546
• Email: samuli.aspinen[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

Procedure:
• SVF
Adipose-derived stromal vascular fraction

Other:
• Splint
Thumb brace (Actimove® Rhizo Forte)

Locations

Country	Name	City	State
Finland	Töölö Hospital (Helsinki University Hospital)	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Töölö Hospital	Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Primary	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)	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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.	6 months
Secondary	Complications	Incidence of complications (hemaetoma, injection site infection etc.)	6 months