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

Not Applicable

• Conditions: Thumb Osteoarthritis

• Registration Number: NCT04455763
• Lead Sponsor: Töölö Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-28
• Study First Submitted QC: 2020-06-28
• Study First Posted: 2020-07-02
• Status Verified: 2021-01
• Study Start: 2021-01-14
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19
• Primary Completion: 2022-09
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain (Visual Analogue Scale)	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)	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)

Secondary Outcome Measures

Name	Time	Method
Grip strength	6 months	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
Key pinch strength	6 months	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
Global improvement	6 months	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
Michigan Hand Outcomes Questionnaire (MHQ)	6 months	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.
Complications	6 months	Incidence of complications (hemaetoma, injection site infection etc.)

Trial Locations

Locations (1)

Töölö Hospital (Helsinki University Hospital); 🇫🇮 Helsinki, Finland