NCT04455763

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

January 14, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

June 28, 2020

Last Update Submit

January 14, 2021

Conditions

Thumb Osteoarthritis

Keywords

Thumb OsteoarthrosisStromal Vascular Fraction

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Global improvement

    6 months

  • Grip strength

    6 months

  • Key pinch strength

    6 months

  • Michigan Hand Outcomes Questionnaire (MHQ)

    6 months

  • Complications

    6 months

Study Arms (2)

SVF

EXPERIMENTAL

Thumb carpometacarpal injection with adipose-derived SVF combined with splinting

Procedure: SVFOther: Splint

Splint

ACTIVE COMPARATOR

Thumb carpometacarpal osteoarthrosis treated with splinting only

Other: Splint

Interventions

SVFPROCEDURE

Adipose-derived stromal vascular fraction

SVF
SplintOTHER

Thumb brace (Actimove® Rhizo Forte)

SVFSplint

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Töölö Hospital (Helsinki University Hospital)

Helsinki, Finland

RECRUITING

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Officials

  • Samuli Aspinen, M.D., Ph.D.

    HUS Töölö Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuli Aspinen, M.D., Ph.D.

CONTACT

+358406360546samuli.aspinen@hus.fi

Jussi Kosola, M.D., Ph.D.

CONTACT

jussi.kosola@helsinki.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 2, 2020

Study Start

January 14, 2021

Primary Completion

September 1, 2022

Study Completion

March 1, 2023

Last Updated

January 19, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)