The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
Trial ID or NCT#
Status
RECRUITING
Purpose
The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups: 1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy. 2. Standard arthroscopic treatment (above) without cell transplant.
Official Title
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
Eligibility Criteria
- - Age between 35 and 70 years-old - Patient is scheduled to undergo one or a combination of the following procedures: - Meniscal debridement or partial menisectomy - Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy - Removal of loose bodies - Chondroplasty - Synovectomy - Soft tissue releases for flexion or extension contracture. - Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3) - < 6 months of knee pain or < 6 months of a significant exacerbation of existing knee pain - Physical examination findings consistent with the proposed surgical procedure. - Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications, with or without concomitant bracing and/or injections
- - Age < 35 or > 70 years old - Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4) - Previous injury or surgery to the infrapatellar fat pad (assessed by MRI) - Patient scheduled to undergo any concomitant surgical procedures with the exception of: - Meniscal debridement or partial menisectomy - Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy - Removal of loose bodies - Chondroplasty - Synovectomy - Soft tissue releases for flexion or extension contracture - Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant - Previous arthroscopy within 1 year - Subchondral edema
Investigator(s)
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Contact
Jason L Dragoo, MD
View on ClinicalTrials.gov