Clinical trial NCT05747469: Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand
Official title: Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Osteoarthritis Hand
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Musculoskeletal Transplant Foundation
First posted: 2023-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose the research is to evaluate the safety and efficacy of injection of adipose allograft matrix (AAM) to the small joints of the hand for treatment of early stage osteoarthritis. The hypothesis is that use of AAM injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options with autologous fat transfer.

As standard of care, routine strength, pain scale scores (VAS) and range of motion will be recorded, a baseline disability survey (DASH score) will also be administered. After these have all been recorded and administered in a separate visit the patient will undergo the lipofilling procedure.

The subject population will include patients over the age of 18 who present with joint pain of the hand with radiographic evidence of osteoarthritis.

Detailed description: The investigators central hypothesis is that use of AAM injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options. The overall aim of the project is to validate the clinical use of AAM for the treatment of early-stage osteoarthritis of the hand in adult patients (\>18 years of age). The specific aims for this project are:

1. To determine the safety of use of Leneva as a lipofilling alternative to autologous fat grafting for arthritis of the hand

   a. To determine safety, the investigators will evaluate for any adverse reactions to the injection at each of the follow up time-points
2. To determine the efficacy of the technique as measured by clinical outcomes in terms of pain, disability, range of motion and strength

   a. To determine efficacy, the investigators will measure visual analogue pain scale scores as measures by visual analogue scale, disability scores as measured with DASH scores, and standardized range of motion and strengths scores as measured by the same study administrator at each of the follow up time points
3. To determine patient satisfaction with the procedure a. To determine patient satisfaction, the investigators will administer a survey at each of the follow up time points

Eligibility criteria: Inclusion Criteria:

* Patients greater than 18 years, with presentation to the Cedars Sinai hand clinic for joint pain of the hand carpometacarpal, interphalangeal, proximal interphalangeal, and distal interphalangeal joints (CMC, IP, PIP or DIP joints).
* Radiographic evidence of osteoarthritis.

Exclusion Criteria:

* Prior intervention for the presenting joint (either in the form of cortisone or hyaluronic acid injection or surgery).
* Rheumatoid or other inflammatory arthritis condition
* Collagen vascular disease
* Pregnancy or breast-feeding
* Congestive heart failure
* Chronic obstructive pulmonary disease
* Chronic renal failure
* Those who had medication or oral supplements for the previous 4 weeks that could prolong bleeding time (e.g.; Aspirin, Plavix).

Primary outcomes:
measure: Range of Motion
timeFrame: Pre-procedure
measure: Range of Motion
timeFrame: 6 weeks
measure: Range of Motion
timeFrame: 6 month
measure: Range of Motion
timeFrame: 12 months
measure: Strength Measures
timeFrame: Pre-procedure
measure: Strength Measures
timeFrame: 6 weeks
measure: Strength Measures
timeFrame: 6 months
measure: Strength Measures
timeFrame: 12 months
measure: Pain scale scores
timeFrame: Pre-procedure
measure: Pain scale scores
timeFrame: 6 weeks
measure: Pain scale scores
timeFrame: 6 months
measure: Pain scale scores
timeFrame: 12 months
measure: Disability Measurement
timeFrame: Pre-procedure
measure: Disability Measurement
timeFrame: 6 weeks
measure: Disability Measurement
timeFrame: 6 months
measure: Disability Measurement
timeFrame: 12 months
measure: Patient satisfaction
timeFrame: Day of procedure
measure: Patient satisfaction
timeFrame: 6 weeks
measure: Patient satisfaction
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Meghan McCullough, MD
role: PRINCIPAL_INVESTIGATOR
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