Knee Osteoarthritis
Conditions
Keywords
stem cell, knee pain, osteoarthritis, arthritis, ADSC, fat stem cell
Brief summary
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.
Detailed description
Adipose-derived stem cells (ADSC) may be beneficial to patients with OA because they may differentiate into chondrocytes, promote endogenous tissue repair, and have potent anti-inflammatory properties. Early studies show promising clinical results using ADSCs to treat patients with osteoarthritis, but no clinical trials have been completed comparing cellular therapy to standard arthroscopic treatment. The investigators aim to determine whether ADSC transplantation as adjuvant therapy in patients with arthroscopic findings of mild to moderate arthritis will result in improved clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic treatment.
Interventions
PROCEDUREArthroscopic debridement with stem cell transplantation
Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
PROCEDUREArthroscopic debridement only
standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
Sponsors
Stanford University
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery | The study will end after 24 month follow-up is completed in all participants. | Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lysholm score | 6, 12, 24 months | Patient reported outcomes measures |
| VR-12 | 6, 12, 24 months | Patient reported outcomes measures |
| Tegner score | 6, 12, 24 months | Patient reported outcomes measures |
Other
| Measure | Time frame | Description |
|---|---|---|
| MRI scans - | 1, 12, 24 months | Average cartilage thickness. Defect fill (percent) routine clinical sequences, T2, T1p |
Countries
United States
Contacts
Primary ContactKaitlyn Whitney
Outcome results
None listed