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Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand
Sponsor: Cedars-Sinai Medical Center
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2023-08-28
Completion Date
2027-01-01
Last Updated
2026-01-02
Healthy Volunteers
Yes
Conditions
Interventions
local anaesthetic injection
Subcutaneous local anesthesia with 1% lidocaine without epinephrine is administered to the skin overlying the joint.
Human Adipose Allograft
Light axial traction of the digit is used to open the joint space when introducing the 18-gauge needle. Fluoroscopy is used to assist with visualization 1 cc of Leneva is injected into the CMC joint and 0.5 cc in the IP, PIP and DIP joints. The puncture is dressed with a band-aid and coban wrap, which will be worn for 48 hours. Return to work and normal use of the hand is recommended at 48 hours. No narcotics are prescribed.
Locations (1)
Cedars-Sinai Medical Center
Los Angeles, California, United States