Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis (REMEDY SVF)

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).

Study Overview

• Status: Recruiting
• Conditions: Thumb Osteoarthritis
• Intervention / Treatment: Procedure: SVF; Other: Splint

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jussi Kosola, M.D., Ph.D.; Email: jussi.kosola@helsinki.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Töölö Hospital (Helsinki University Hospital)
    • Contact: Jorma Ryhänen, adj. prof; Email: jorma.ryhanen@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SVF; Thumb carpometacarpal injection with adipose-derived SVF combined with splinting	Procedure: SVF; Adipose-derived stromal vascular fraction; Other: Splint; Thumb brace (Actimove® Rhizo Forte)
Active Comparator: Splint; Thumb carpometacarpal osteoarthrosis treated with splinting only	Other: Splint; Thumb brace (Actimove® Rhizo Forte)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Complications	Incidence of complications (hemaetoma, injection site infection etc.)	6 months

Collaborators and Investigators

• Sponsor: Töölö Hospital
• Collaborators: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: June 28, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Thumb Osteoarthrosis; Stromal Vascular Fraction
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 1866/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No