Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Instituto Nacional de Rehabilitacion
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Aldo Izaguirre, Instituto Nacional de Rehabilitacion
ClinicalTrials.gov Identifier:
NCT01947374
First received: February 4, 2012
Last updated: September 17, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Instituto Nacional de Rehabilitacion:

Primary Outcome Measures:
  • MRI T2 Mapping [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Clinical assessment with validated knee scores, and adverse effects register are taken.


Estimated Enrollment: 48
Study Start Date: January 2010
Estimated Study Completion Date: January 2015
Estimated 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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947374

Contacts
Contact: Aldo F Izaguirre, M.D. 525559991000 ext 19607 aldoizag@gmail.com
Contact: Enrique Villalobos, M.D. 525559991000 ext 19607 villalobosenrique@hotmail.com

Locations
Mexico
National Institute of Rehabilitation Recruiting
Mexico City, Mexico, 14389
Contact: Aldo F Izaguirre, M.D.    525559991000 ext 1960    aldoizag@gmail.com   
Principal Investigator: Clemente Ibarra, M.D.         
Sub-Investigator: Enrique Villalobos, M.D.         
Sub-Investigator: Aldo Izaguirre, M.D. M.Sc.         
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
  More Information

Additional Information:
Publications:
Responsible Party: Aldo Izaguirre, Dr./Study Director, Instituto Nacional de Rehabilitacion
ClinicalTrials.gov Identifier: NCT01947374     History of Changes
Other Study ID Numbers: 017-05-INR
Study First Received: February 4, 2012
Last Updated: September 17, 2013
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Instituto Nacional de Rehabilitacion:
Cartilage
Articular

ClinicalTrials.gov processed this record on October 20, 2014