Comparing two methods for treating knee cartilage defects
Randomized Controlled Trial of Microfracture Versus Adipose Derived Stem Cells for the Treatment of Isolated Articular Cartilage Defects
NA · University of Colorado, Denver · NCT02090140
This study is testing whether using fat-derived stem cells is better than the standard microfracture technique for treating knee cartilage defects in patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 3 sites (Redwood City, California and 2 other locations) |
| Trial ID | NCT02090140 on ClinicalTrials.gov |
What this trial studies
This study compares two biological approaches for treating articular cartilage defects in the knee: the standard microfracture technique and the application of adipose-derived stem cells (ADSCs). The microfracture method recruits cells from the subchondral bone marrow, while the ADSC method aims to deliver specific progenitor cells using a collagen scaffold for improved cartilage regeneration. Patients will undergo arthroscopic procedures to collect fat for ADSC processing and to prepare the cartilage defect site. Outcomes will be assessed through questionnaires and MRI scans at 6, 12, and 24 months post-surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 50 with specific contained chondral defects in the knee and neutral lower limb alignment.
Not a fit: Patients over 50 years old, those with previous chondral procedures, pre-existing osteoarthritis, or a BMI over 30 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatments for knee cartilage defects, improving patient recovery and joint function.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific comparison of microfracture and ADSC application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be between ages 18 and 50 years. * Must have a discrete, contained chondral defect less than 400mm\^2 located on the medial or lateral femoral condyle * Must have overall neutral lower limb mechanical alignment (\<5 degrees varus or valgus). Exclusion Criteria: * Ages younger than 18 years and older than 50 years. * If they have undergone previous chondral procedures * If they have pre-existing osteoarthritis (Kellegren-Lawrence Grade ≥2) * If they have a BMI \>30.
Where this trial is running
Redwood City, California and 2 other locations
- Stanford Medical Outpatient Center — Redwood City, California, United States (ACTIVE_NOT_RECRUITING)
- Kerlan Jobe Orthopedic Institute — Santa Monica, California, United States (RECRUITING)
- UC Health Steadman Hawkins Clinic - Denver Inverness — Denver, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Jason Dragoo, MD — University of Colorado, Denver
- Study coordinator: Kaitlyn Whitney
- Email: Inverness.clinicaltrials@cuanschutz.edu
- Phone: (720) 872-4836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Degenerative Lesion of Articular Cartilage of Knee, cartilage/transplantation, cartilage, articular/injuries, cartilage, articular/surgery, chondrocytes/cytology, knee injuries/surgery, knee joint/surgery, orthopedic procedures/methods