Study Comparing NOVOCART 3D and Microfracture Surgery for Treatment of Articular Knee Cartilage

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-005420
    NCT ID: NCT01957722
    Sponsor Protocol Number: AAG-G-H-1220

About this study

The purpose of this research study is to gather information on the safety and effectiveness of Autologous Chondrocyte Transplantation system, Novocart® 3D, in comparison to standard microfracture treatment for injured knee.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Greater than 18 years old   
  • Isolated articular cartilage lesions on the femoral condyle 2-6 cm2 
  • Minimum score on the KOOS questionnaire

Exclusion Criteria

  • Instability of the knee joint 
  • Arthritis 
  • Autoimmune disease 
  • Immune suppression 
  • Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline)
  • Bone disease 
  • Any degenerative muscular, connective tissue, neurological condition, or other disease process that would interfere with healing or the evaluation of outcome measures

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aaron Krych, M.D.

Open for enrollment

Contact information:

Jennifer Krogman

(507)538-3562

Krogman.Jennifer@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20271798

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