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Completed

NCT Number: NCT01947374

Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

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.

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Key information

Conditions

Tear; Knee, Cartilage, Articular Lacerations Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Institute of Rehabilitation

Mexico City, 14389, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Matrix encapsulated chondrocyte implantation

Procedure

Each implant contains 6,000,000 autologous chondrocytes.

Microfracture awl

Procedure

Is an awl that allow perforation of the subchondral bone.

Primary outcomes

  1. MRI T2 Mapping

    Time frame: 24 months

    Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Rehabilitacion

Other Gov

Collaborators

  • National Council of Science and Technology, Mexico

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 20, 2013
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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