Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

April 11, 2017 updated by: Aldo Izaguirre, Instituto Nacional de Rehabilitacion

Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Mexico
      • Mexico City, Mexico, 14389
        • National Institute of Rehabilitation

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

Genders Eligible for Study

All

Description

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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI T2 Mapping
Time Frame: 24 months
Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months

Collaborators and Investigators

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

Sponsor

Instituto Nacional de Rehabilitacion

Collaborators

National Council of Science and Technology, Mexico

Investigators

  • Study Chair: Luis G Ibarra, M.D., INR
  • Study Director: Aldo F Izaguirre, M.D. M.Sc., INR

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

Helpful Links

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

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

February 4, 2012

First Submitted That Met QC Criteria

September 17, 2013

First Posted (ESTIMATE)

September 20, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017-05-INR

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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