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Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01947374
First Posted: September 20, 2013
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Aldo Izaguirre, Instituto Nacional de Rehabilitacion
  Purpose
This is a phase III, randomised controlled trial of matrix-encapsulated chondrocyte implantation procedure compared to the microfracture procedure in the repair of symptomatic cartilage lesions of the knee. Eligible patients were asked for informed consent preoperatively and randomised for chondrocyte implantation of microfractures. Those patients allocated to the chondrocyte implantation group will be harvested at time of first arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament reconstruction, or malalignment corrected. The patients allocated to microfracture will be treated at the time of the only arthroscopic procedure. Both groups will have the same rehabilitation program. Prospective clinical, radiographic and magnetic resonance imaging will be performed as main outcomes.

Condition Intervention Phase
Tear; Knee, Cartilage, Articular Procedure: Matrix encapsulated chondrocyte implantation Procedure: Microfracture awl Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.

Further study details as provided by Aldo Izaguirre, Instituto Nacional de Rehabilitacion:

Primary Outcome Measures:
  • MRI T2 Mapping [ Time Frame: 24 months ]
    Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.


Secondary Outcome Measures:
  • Clinical evaluation [ Time Frame: 0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months ]
    Clinical assessment with validated knee scores, and adverse effects register are taken.


Enrollment: 48
Study Start Date: January 2010
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chondrocyte implantation
From a previous biopsy, articular cartilage matrix is digested and chondrocytes are cultured in 2 passages until implants with at least 6,000,000 cells are constructed. These constructus of 8 mm in diameter are implanted arthroscopically by means of biodegradable anchor (MINILOK QUICKANCHOR TM from DePuy-Mitek ) located at the defect and tied securely.
Procedure: Matrix encapsulated chondrocyte implantation
Each implant contains 6,000,000 autologous chondrocytes.
Experimental: Microfractures
Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area.
Procedure: Microfracture awl
Is an awl that allow perforation of the subchondral bone.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with symptomatic single chondral lesions of the knee from 1 to 4 cm2.
  • Signed patient informed consent.
  • Agree to adhere to rehabilitation protocol.

Exclusion Criteria:

  • Inflammatory arthritis, septic arthritis, gout, pseudogout, Paget's disease, ochronosis, acromegaly, hemochromatosis, tumors, collagen mutations.
  • Total meniscectomy
  • Malalignment
  • Evidence of osteoarthritis
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01947374


Locations
Mexico
National Institute of Rehabilitation
Mexico City, Mexico, 14389
Sponsors and Collaborators
Instituto Nacional de Rehabilitacion
National Council of Science and Technology, Mexico
Investigators
Principal Investigator: Clemente Ibarra, M.D. INR
Study Chair: Luis G Ibarra, M.D. INR
Study Director: Enrique Villalobos, M.D. INR
Study Director: Aldo F Izaguirre, M.D. M.Sc. INR