Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborator: Musculoskeletal Transplant Foundation
• Treatments: Anesthetics; Anesthetics, Local; Lidocaine

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).