ArthritisPhase 2NCT05005000
Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
A Phase 2 study testing Micro-Fragmented Adipose Tissue (MFAT) and Triamcinolone Acetonide 10mg/mL in people with Arthritis, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Micro-Fragmented Adipose Tissue (MFAT) and Triamcinolone Acetonide 10mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2022to 25 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Arthritis
- Being tested
- Micro-Fragmented Adipose Tissue (MFAT), Triamcinolone Acetonide 10mg/mL
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-Fragmented Adipose Tissue (MFAT)Biological
1ml of autologous micro-fragmented adipose tissue will be used.
Triamcinolone Acetonide 10mg/mLDrug
Also called Kenalog-10
The control group will receive a 1ml intraarticular injection of triamcinolone acetonide 10mg/ml.
| Study group | Role | What they receive |
|---|---|---|
| MFAT | Experimental | Not described Receives: Biological: Micro-Fragmented Adipose Tissue (MFAT) |
| Steroid (Control) | Active comparator | Not described Receives: Drug: Triamcinolone Acetonide 10mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, Month 12
Secondary outcomes (3)
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.
Measured: Baseline, Month 12
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.
Measured: Baseline, Month 12
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.
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start12 May 2022
- Primary completion25 May 2023
- Study completion25 May 2023
Why it stopped: Difficulties getting subjects recruited and enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Hacquebord, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005000
- Sponsor's protocol ID
- 21-00996
- Status last verified
- Jan 2024
- First submitted
- 12 Aug 2021
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
- ClinicalTrials.gov ID
- NCT05005000
- Acronym / sponsor ID
- 21-00996
- Conditions
- Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties getting subjects recruited and enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MFAT | Experimental | Biological: Micro-Fragmented Adipose Tissue (MFAT) |
| Steroid (Control) | Active comparator | Drug: Triamcinolone Acetonide 10mg/mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-Fragmented Adipose Tissue (MFAT)1ml of autologous micro-fragmented adipose tissue will be used. | Biological | MFAT |
| Triamcinolone Acetonide 10mg/mLAlso: Kenalog-10The control group will receive a 1ml intraarticular injection of triamcinolone acetonide 10mg/ml. | Drug | Steroid (Control) |
Primary outcome
Percent Change in Score on Pain Visual Analog Scale (VAS)
Time frame: Baseline, Month 12
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)
3 secondary outcomes
Change in Score on Thumb Disability Exam (TDX)
Time frame: Baseline, Month 12
Change in Shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Score
Time frame: Baseline, Month 12
Change in Kapandji Range of Motion Score
Time frame: Baseline, Month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Hacquebord, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micro-Fragmented Adipose Tissue (MFAT) and Triamcinolone Acetonide 10mg/mL in people with Arthritis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Score on Pain Visual Analog Scale (VAS) (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.