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Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis

Primary Purpose

Arthritis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Micro-Fragmented Adipose Tissue (MFAT)
Triamcinolone Acetonide 10mg/mL
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years old or older; male and female patients
  2. Eaton-Glickel stage 2-3 thumb CMC arthritis
  3. Failed conservative treatment (i.e. hand therapy, pain medications, splinting)
  4. Able to provide informed consent

Exclusion Criteria:

  1. Pregnancy/breastfeeding
  2. Inflammatory or posttraumatic arthritis
  3. Prior thumb base trauma or surgery
  4. Evidence of skin infection or soft tissue loss at the thumb CMC joint or adipose harvest site
  5. Active local or systemic malignancy
  6. Known allergy to any study drug

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MFAT

Steroid (Control)

Arm Description

Outcomes

Primary Outcome Measures

Percent Change in Score on Pain Visual Analog Scale (VAS)
Pain severity scores will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)

Secondary Outcome Measures

Change in Score on Thumb Disability Exam (TDX)
TDX consists of 20 questions and assess the function of the participant's thumbs over the past week. Each question is scored from 1 (not difficult) to 5 (unable). TDX is scored on a scale of 1 to 100, with a higher score indicating a greater degree of disability in the thumb.
Change in Shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Score
QuickDASH consists of 11 questions -- the participants are asked to rate their ability to do activities in the last week on a scale of 1 (no difficulty) to 5 (unable). The disability/symptom score is calculated by ((sum of n responses/n)-1)x25, where n is equal to the number of completed responses. The total score ranges from 0 to 250; higher scores indicate greater degree of disability.
Change in Kapandji Range of Motion Score
A Kapandji score is used to assess the movement of opposition (being able to touch one's thumb to areas of one's hand). It is vital in hand function and grip. The total score ranges from 1 to 10; a higher score indicates the thumb being able to touch a further area on the hand.

Full Information

First Posted
August 12, 2021
Last Updated
June 2, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05005000
Brief Title
Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
Official Title
Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulties getting subjects recruited and enrolled.
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
32 patients with Eaton-Glickel stage 2-3 CMC arthritis will be randomized to receive intraarticular MFAT or intraarticular corticosteroid injection. Patients with inflammatory arthritis or prior thumb base trauma or surgery will be excluded. Autologous adipose tissue will be harvested from the outer thigh or lower abdomen using local anesthesia. Tissue will be processed to remove oil and debris in-office using an FDA-approved commercially available device. The processed adipose will be immediately injected into the thumb CMC joint under fluoroscopic guidance. Visual analogue score (VAS), grip/pinch strength, Kapandji range of motion score, thumb disability examination, and QuickDASH score will be assessed pre-procedure and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MFAT
Arm Type
Experimental
Arm Title
Steroid (Control)
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Micro-Fragmented Adipose Tissue (MFAT)
Intervention Description
1ml of autologous micro-fragmented adipose tissue will be used.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide 10mg/mL
Other Intervention Name(s)
Kenalog-10
Intervention Description
The control group will receive a 1ml intraarticular injection of triamcinolone acetonide 10mg/ml.
Primary Outcome Measure Information:
Title
Percent Change in Score on Pain Visual Analog Scale (VAS)
Description
Pain severity scores will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)
Time Frame
Baseline, Month 12
Secondary Outcome Measure Information:
Title
Change in Score on Thumb Disability Exam (TDX)
Description
TDX consists of 20 questions and assess the function of the participant's thumbs over the past week. Each question is scored from 1 (not difficult) to 5 (unable). TDX is scored on a scale of 1 to 100, with a higher score indicating a greater degree of disability in the thumb.
Time Frame
Baseline, Month 12
Title
Change in Shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Score
Description
QuickDASH consists of 11 questions -- the participants are asked to rate their ability to do activities in the last week on a scale of 1 (no difficulty) to 5 (unable). The disability/symptom score is calculated by ((sum of n responses/n)-1)x25, where n is equal to the number of completed responses. The total score ranges from 0 to 250; higher scores indicate greater degree of disability.
Time Frame
Baseline, Month 12
Title
Change in Kapandji Range of Motion Score
Description
A Kapandji score is used to assess the movement of opposition (being able to touch one's thumb to areas of one's hand). It is vital in hand function and grip. The total score ranges from 1 to 10; a higher score indicates the thumb being able to touch a further area on the hand.
Time Frame
Baseline, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old or older; male and female patients Eaton-Glickel stage 2-3 thumb CMC arthritis Failed conservative treatment (i.e. hand therapy, pain medications, splinting) Able to provide informed consent Exclusion Criteria: Pregnancy/breastfeeding Inflammatory or posttraumatic arthritis Prior thumb base trauma or surgery Evidence of skin infection or soft tissue loss at the thumb CMC joint or adipose harvest site Active local or systemic malignancy Known allergy to any study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Hacquebord, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data upon reasonable request. Requests should be directed to Jacques.Hacquebord@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis

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