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

Primary Purpose

Thumb Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
SVF
Splint
Sponsored by
Töölö Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thumb Osteoarthritis focused on measuring Thumb Osteoarthrosis, Stromal Vascular Fraction

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Töölö Hospital (Helsinki University Hospital)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SVF

Splint

Arm Description

Thumb carpometacarpal injection with adipose-derived SVF combined with splinting

Thumb carpometacarpal osteoarthrosis treated with splinting only

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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
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
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
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.
Complications
Incidence of complications (hemaetoma, injection site infection etc.)

Full Information

First Posted
June 28, 2020
Last Updated
January 14, 2021
Sponsor
Töölö Hospital
Collaborators
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04455763
Brief Title
Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis
Acronym
REMEDY SVF
Official Title
Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis - ReMeDY SVF -Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Töölö Hospital
Collaborators
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis
Keywords
Thumb Osteoarthrosis, Stromal Vascular Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SVF
Arm Type
Experimental
Arm Description
Thumb carpometacarpal injection with adipose-derived SVF combined with splinting
Arm Title
Splint
Arm Type
Active Comparator
Arm Description
Thumb carpometacarpal osteoarthrosis treated with splinting only
Intervention Type
Procedure
Intervention Name(s)
SVF
Intervention Description
Adipose-derived stromal vascular fraction
Intervention Type
Other
Intervention Name(s)
Splint
Intervention Description
Thumb brace (Actimove® Rhizo Forte)
Primary Outcome Measure Information:
Title
Pain (Visual Analogue Scale)
Description
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)
Time Frame
6 months
Title
Patient-Rated Wrist Evaluation (PRWE)
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Global improvement
Description
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
Time Frame
6 months
Title
Grip strength
Description
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
Time Frame
6 months
Title
Key pinch strength
Description
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
Time Frame
6 months
Title
Michigan Hand Outcomes Questionnaire (MHQ)
Description
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.
Time Frame
6 months
Title
Complications
Description
Incidence of complications (hemaetoma, injection site infection etc.)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuli Aspinen, M.D., Ph.D.
Phone
+358406360546
Email
samuli.aspinen@hus.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Jussi Kosola, M.D., Ph.D.
Email
jussi.kosola@helsinki.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuli Aspinen, M.D., Ph.D.
Organizational Affiliation
HUS Töölö Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Töölö Hospital (Helsinki University Hospital)
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuli Aspinen, M.D., Ph.D.
Phone
+358406360546
Email
samuli.aspinen@hus.fi
First Name & Middle Initial & Last Name & Degree
Jorma Ryhänen, adj. prof
Email
jorma.ryhanen@hus.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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