Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT05747469
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand
Sponsor:
Cedars-Sinai Medical Center
Organization:
Study Overview
Official Title:
Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: