Status:
UNKNOWN
Intra-articular Adipose Tissue Injections for Osteoarthritis
Lead Sponsor:
University of Southern California
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
A new generation of "minimally manipulated" regenerative treatments are being offered at clinics across the country, but there is no strong efficacy data to support their use. The purpose of this stud...
Detailed Description
In recent years, fat treatments administered for structural reconstruction, repair, or replacement are being increasingly offered at clinics across the country. These treatments contain both autologou...
Eligibility Criteria
Inclusion
- Age 45 to 75, inclusive
- Normal axial alignment
- X-ray, Kellgren-Lawrence OA grade 2 - 3, inclusive
- WOMAC-pain: Between 9 and 19, inclusive
- Willingness to participate all scheduled follow-ups
- Willingness to refrain from taking NSAIDs, level 2 analgesics, and opioids for the course of the study
- BMI \< 40
Exclusion
- Pregnant or lactating
- Intra-articular injection within 3 months of treatment
- Inflammatory arthritis
- Any disease or active drug use that significantly compromises coagulation
- Significant damage and/or tears of the ACL or other supporting tissues
- Prior knee surgery in the last 6 months in the knee that will be injected
- Active tobacco use
- Active alcohol or substance abuse within 6 months of study entry
- Known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations
- Knee joint infections, skin diseases or infections in the area of the injection site
- Diabetes
- Active inhaler use
- Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome evaluation
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03242707
Start Date
July 1 2018
End Date
December 1 2020
Last Update
October 3 2019
Active Locations (1)
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1
Keck Medicine of USC
Los Angeles, California, United States, 90033