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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05747469
Study type	Interventional
Source	Cedars-Sinai Medical Center
Contact	Joel C Program Manager
Phone	(310) 423-4614
Email	joel.arnold@cshs.org
Status	Recruiting
Phase	Early Phase 1
Start date	August 28, 2023
Completion date	January 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05923736` - Cardiovascular Risk in Digital Osteoarthritis	N/A
Recruiting	`NCT05484089` - CapFlex PIP Implant RSA
Active, not recruiting	`NCT04928170` - The Halland Osteoarthritis Cohort
Recruiting	`NCT05160038` - Embodied Virtual Reality for Chronic Pain	N/A
Not yet recruiting	`NCT05351060` - Novel Splinting Technique Using 3D Models	N/A
Active, not recruiting	`NCT05250726` - Use of a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) in the Treatment of Scaphotrapeziotrapezoid Osteoarthritis	Phase 2
Completed	`NCT04263974` - Effectiveness of an Exercise Program and Education Through a Mobile Application for the Management of Patients With Hand Osteoarthritis and Rheumatoid Arthritis	N/A
Recruiting	`NCT05378841` - Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis	N/A
Not yet recruiting	`NCT06034262` - Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis	Phase 2
Not yet recruiting	`NCT06038331` - Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis	Phase 2
Completed	`NCT04601883` - Colchicine as Treatment for People With Hand Osteoarthritis	Phase 4
Completed	`NCT03067194` - The Study to Evaluate Efficacy and Safety of Celecoxib Capsule in Hand Osteoarthritis Patients	Phase 4
Completed	`NCT05041231` - Effects of Using Custom Photobiomodulation Therapy for the Treatment of Osteoarthritis of the Fingers and Rhizarthrosis	N/A
Completed	`NCT03173989` - Strategies for Patients With Osteoarthritis, by Using Assistive Technology and Exercises.	N/A
Active, not recruiting	`NCT05363020` - S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.