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Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

NCT01947374 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-04-12

No results posted yet for this study

Summary

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.

Conditions

  • Tear; Knee, Cartilage, Articular

Interventions

PROCEDURE

Matrix encapsulated chondrocyte implantation

Each implant contains 6,000,000 autologous chondrocytes.

PROCEDURE

Microfracture awl

Is an awl that allow perforation of the subchondral bone.

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Instituto Nacional de Rehabilitacion

    lead OTHER_GOV

Principal Investigators

  • Clemente Ibarra, M.D. · INR

  • Luis G Ibarra, M.D. · INR

  • Enrique Villalobos, M.D. · INR

  • Aldo F Izaguirre, M.D. M.Sc. · INR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01947374 on ClinicalTrials.gov