Recruiting

Microfracture vs. Adipose Derived Stem Cells

Sponsor:

University of Colorado, Denver

Code:

NCT02090140

Conditions

Degenerative Lesion of Articular Cartilage of Knee

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

ADSC Application

Microfracture

Study Details

Brief summary:

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.

Conditions

Degenerative Lesion of Articular Cartilage of Knee

Study ID

NCT02090140

Start date

Nov, 2015

Status verified date

Apr, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

17 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ADSC Application

Patients undergo an arthroscopic surgical procedure, ADSC application, followed by physical therapy.

active comparator: Microfracture Arm

Patients undergo an arthroscopic surgical procedure, microfracture, followed by physical therapy.

Interventions

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.

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).

Primary outcome measure

  • Health Scores on the KOOS Questionnaire [ Time Frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively. ]

Central Contacts and Locations

Central contacts

Kaitlyn Whitney

(720) 872-4836Inverness.clinicaltrials@cuanschutz.edu

Locations

Kerlan Jobe Orthopedic Institute

Recruiting

Santa Monica, California, United States, 90404

Contacts

Jasmine Galloway, B.S.

310-829-2663jasmine.galloway@cskerlanjobe.org

UC Health Steadman Hawkins Clinic - Denver Inverness

Recruiting

Denver, Colorado, United States, 80112

Contacts

Veronica Butler

720-872-0112dragoo.lab@ucdenver.edu

Kaitie Whitney

(720)872-0112dragoo.lab@ucdenver.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 25, 2024

Last verified

Apr, 2024

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-04-25.