Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects

April 24, 2024 updated by: University of Colorado, Denver

Randomized Controlled Trial of Microfracture Versus Adipose Derived Stem Cells for the Treatment of Isolated Articular Cartilage Defects

The purpose of this study is to compare two biologic methods for the treatment of articular cartilage defects in the knee. The first method, microfracture, is the standard of care and is routinely used to recruit cells from the subchondral bone marrow to the site of cartilage loss. The second method is the application of adipose-derived stem cells (ADSCs) to the defect site. In theory, ADSCs on a collagen scaffold should enable the delivery of more specific progenitor cells to the site of injury, resulting in better regeneration and integration of articular cartilage at the site of a defect as compared to the microfracture method.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Active, not recruiting
        • Stanford Medical Outpatient Center
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Kerlan Jobe Orthopedic Institute
        • Contact:
        • Sub-Investigator:
          • Burt Mandelbaum, M.D.
    • Colorado
      • Denver, Colorado, United States, 80112
        • Recruiting
        • UC Health Steadman Hawkins Clinic - Denver Inverness
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADSC Application
Patients undergo an arthroscopic surgical procedure, ADSC application, followed by physical therapy.
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.
Active Comparator: Microfracture Arm
Patients undergo an arthroscopic surgical procedure, microfracture, followed by physical therapy.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Completed at baseline, 6 months, 12 months, and 24 months post-operatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
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.
Assessed at baseline, 6 months, 12 months, and 24 months post-operatively.
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.
Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
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.
Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
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.
Completed at baseline, 6 months, 12 months, and 24 months post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Stanford University
University of Kentucky

Investigators

  • Principal Investigator: Jason Dragoo, MD, University of Colorado - Anschutz Medical Campus
  • Principal Investigator: Seth L Sherman, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimated)

March 18, 2014

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-2838

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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