Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects
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| ClinicalTrials.gov Identifier: NCT02090140 |
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Recruitment Status :
Recruiting
First Posted : March 18, 2014
Last Update Posted : May 24, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Degenerative Lesion of Articular Cartilage of Knee | Procedure: ADSC Application Procedure: Microfracture | Not Applicable |
Patients enrolled in the ADSC cohort will undergo the following procedures: arthroscopic resection of approximately 5cc of the infrapatellar fat pad using a motorized shaver (standard use in arthroscopy). Fat will be collected in a sterile Aquavage Collection System (AV1200, MD Resources, Livermore, CA) and kept sealed until processing. Fat will then immediately be processed in the Harvest Adiprep System to separate a population of ADSCs. This system concentrates an average of 5 x 105 cells/ml. All specimens will be processed using routine sterile procedures within the operating room; cells destined for implantation will not leave the operating room. Concurrently, patients will undergo arthroscopy and similar preparation of the chondral defect and removal of the calcified cartilage layer. However, no puncture of the subchondral bone will be performed. A layer of fibrin glue (Tisseel) will be placed at the base of the defect to seal off any bleeding from the subchondral plate followed by the application of the acellular dermal matrix (Allopatch HD, MTF Corporation, Edison, NJ, USA)and ADSCs. An additional layer of Tisseel will then be applied over the cells and matrix. No additional fixation will be applied. The matrix and cells will be recessed below the articular surface by an average of 1mm.
They will then complete outcome questionnaires and additional MRI scans at 6, 12, and 24 months post-operatively.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 17 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Controlled Trial of Microfracture Versus Adipose Derived Stem Cells for the Treatment of Isolated Articular Cartilage Defects |
| Study Start Date : | November 2015 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: ADSC Application
Patients undergo an arthroscopic surgical procedure, ADSC application, followed by physical therapy.
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Procedure: ADSC Application
Patients will undergo arthroscopic resection of approximately 5cc of the infrapatellar fat pad, which will be collected for processing for a population of ADSCs. Patients will undergo arthroscopy and preparation of the chondral defect and removal of the calcified cartilage layer. Tisseel Fibrin glue will be placed at the base of the defect side, followed by the application of the acellular collagen dermal matrix, ADSCs, and an additional layer of fibrin glue. |
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Active Comparator: Microfracture Arm
Patients undergo an arthroscopic surgical procedure, microfracture, followed by physical therapy.
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Procedure: Microfracture
Microfracture surgery is the standard of care for articular cartilage lesions. Patients will undergo arthroscopy with standard technique of microfracture preparation, including the creation of vertical, stable defect edges and removal of the calcified cartilage layer. A microfracture awl will then be used to perform the microfracture technique (6mm below the subchondral plate). |
- Health Scores on the KOOS Questionnaire [ Time Frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively. ]The Knee Osteoarthritis Outcome Score (KOOS), a standard outcome questionnaire for the assessment of health-related quality of life, will be completed.
- Activity Level on the Tegner Activity Scale [ Time Frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively. ]The Tegner Activity scale, a standard outcome questionnaire for assessment of activity levels, will be completed.
- Cartilage Composition Assessment by MRI Scan [ Time Frame: Assessed at baseline, 6 months, 12 months, and 24 months post-operatively. ]Magnetic resonance imaging scans consisting of routine clinical sequences and T2 and T1p quantitative maps will be conducted. T1p and T2 mapping will be used to assess regenerative cartilage composition compared to surrounding normal cartilage, surface integrity, average cartilage thickness, and the percentage to which the defect is filled.
- Functionality Scores on the Lysholm Scale [ Time Frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively. ]The Lysholm Scale, a standard outcome questionnaire for assessment of knee functionality, will be completed.
- Pain Scores on the Visual Analog Scale (VAS) [ Time Frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively. ]The Visual Analog Scale, a standard outcome questionnaire for assessment of pain levels, will be completed.
- Health Scores on Veterans-Rand (VR-12) Survey [ Time Frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively. ]The Veterans-Rand survey, a standard outcome questionnaire for assessment of health and quality of life, will be completed.
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090140
| Contact: Veronica Butler | (720)872-0112 | dragoo.lab@ucdenver.edu | |
| Contact: Kaitie Whitney | (720)872-0112 | dragoo.lab@ucdenver.edu |
| United States, California | |
| Stanford Medical Outpatient Center | Active, not recruiting |
| Redwood City, California, United States, 94063 | |
| Kerlan Jobe Orthopedic Institute | Recruiting |
| Santa Monica, California, United States, 90404 | |
| Contact: Jasmine Galloway, B.S. 310-829-2663 jasmine.galloway@cskerlanjobe.org | |
| Sub-Investigator: Burt Mandelbaum, M.D. | |
| United States, Colorado | |
| UC Health Steadman Hawkins Clinic - Denver Inverness | Recruiting |
| Denver, Colorado, United States, 80112 | |
| Contact: Veronica Butler 720-872-0112 dragoo.lab@ucdenver.edu | |
| Contact: Kaitie Whitney (720)872-0112 dragoo.lab@ucdenver.edu | |
| Principal Investigator: | Jason Dragoo, MD | University of Colorado - Anschutz Medical Campus | |
| Principal Investigator: | Seth L Sherman, MD | Stanford University |
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT02090140 |
| Other Study ID Numbers: |
19-2838 |
| First Posted: | March 18, 2014 Key Record Dates |
| Last Update Posted: | May 24, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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cartilage/transplantation cartilage, articular/injuries cartilage, articular/surgery chondrocytes/cytology knee injuries/surgery knee joint/surgery orthopedic procedures/methods tissue engineering tissue scaffolds arthroscopy/methods chondrocytes/transplantation |
adipose tissue/cytology cartilage, articular/cytology chondrogenesis/physiology osteogenesis/physiology stem cell transplantation/methods stem cells tissue engineering/methods cartilage, articular/pathology chondrocytes/pathology knee joint/pathology platelet-rich plasma |
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Fractures, Stress Fractures, Bone Wounds and Injuries |