RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-28
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05747469

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * Radiographic evidence of osteoarthritis.
  1. * Prior intervention for the presenting joint (either in the form of cortisone or hyaluronic acid injection or surgery).
  2. * Rheumatoid or other inflammatory arthritis condition
  3. * Collagen vascular disease
  4. * Pregnancy or breast-feeding
  5. * Congestive heart failure
  6. * Chronic obstructive pulmonary disease
  7. * Chronic renal failure
  8. * Those who had medication or oral supplements for the previous 4 weeks that could prolong bleeding time (e.g.; Aspirin, Plavix).

Contacts and Locations

Study Contact

Joel C Program Manager
CONTACT
(310) 423-4614
joel.arnold@cshs.org
Laura Program Manager
CONTACT
(310) 423-4295
laura.sarmeinto@cshs.org

Principal Investigator

Meghan McCullough, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Meghan McCullough, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-28
Study Completion Date2025-01

Study Record Updates

Study Start Date2023-08-28
Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoarthritis Hand