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 - Screening Visit:

  • Men and women between 18 and 65 years of age at time of treatmentscreening with symptomatic knee pain indicative of articular cartilage defects of the knee with inadequate response to conservative treatment (e.g., analgesics, rest and physical therapy).
  • Intact ligaments or sufficiently repaired ligaments such that the target knee is stable at time of procedure.
  • Full range of motion of the affected joint (relative to normal knee) defined as : No loss of range of motion of affected limb >5° on extension and >15 ° flexion compared to contralateral knee
  • Normally functioning contralateral knee.
  • Maximum calculated score of 50 out of possible 100 on the KOOS subdomain of pain scale. (mMinimum rRaw score of 18 out of 36).
  • Maximum calculated score of 63 out of possible 100 on the KOOS subdomain of Activities of Daily Living scale. (mMinimum Rraw score of 25 out of 68).
  • Subjects who are willing to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations.
  • Life expectancy greater than 5 years.
  • Willing and able to perform the study treatments and procedures, able to comply with post-op rehabilitation and sign an Informed Consent and HIPAA authorization.

During Surgery:

At surgery, the screening visit inclusion criteria must again be reviewed and met, along with the following:

  • Articular cartilage defect of the medial, lateral or trochlear femoral condyle with a total area of 2.0 - 6.0 cm2 as measured with a graduated probe across the widest portions of the lesion and treatable with one implant
  • Defect-grade III or IV according to the ICRS-classification.

Exclusion Criteria:

Subjects will not be considered for participation in the study if any of the following criteria listed below apply or are discovered prior to randomization:

  • Severe obesity (BMI > 40).
  • Surgery on the contralateral knee within the 6 months prior to the scheduled arthroscopy.
  • Intra-articular injections within 1 month of surgery.
  • Prior release and excision of scar tissue except isolated lateral release on target knee.
  • Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture on the target knee.
    • Note: prior debridement and lavage are acceptable if more than three months have passed
  • Clinically significant low back and/or lower extremity pain not due to the articular cartilage defect.
  • Women of child bearing potential must test negative on standard urine pregnancy test and must agree to practice appropriate contraceptive methods for the first 24 months of the study (e. g. oral contraceptive, double barrier method, IUD, intra-muscular contraceptive).
  • Clinically significant rheumatological disease (including Lyme, Fibromyalgia) .
  • Clinically significant arthritis.
  • Radiologically apparent degenerative joint disease as assessed by X-ray within 3 months of screening including joint space narrowing greater than one third when compared to the normal knee or less than 3 mm joint space measured on x-ray (including, but not limited to, weight bearing AP, PA flexed and lateral with magnification spheres; merchant view; hip to ankle alignment images) (in standing views).
  • Documented abnormalities of clinically relevant bone integrity or bone healing (including hyperparathyroid and osteoporosis or osteopenia, chronic renal failure or have had previous fragility fractures unless there is a documented Dexa T-score of >-1 within the past 3 months).
  • Bone diseases including but not limited to Paget’s Disease.
  • Immune suppression (including CD4 values under 200; and/or chemotherapy).
  • Immune modulating drugs such as immunosuppressants (ex. Imuran;) phosphonates; antimetabolites (ex. methotrexate), Gabapentin (neurontin) and Pregabaline (ex Lyrica).
  • Current steroid (anabolic or corticosteroid) use or steroid use within the last 3 months prior to screening.
  • Autoimmune disease (including Lupus, ankylosing spondylitis or sero negative arthropathy).
  • Connective tissue or collagen disease including but not limited to Ehler-Danlos.
  • Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere healing or the evaluation of outcome measures including but not limited to Parkinson’s disease, acute lateral sclerosis, multiple sclerosis.
  • Current diagnosis or treatment for any infectious diseases at time of surgery.
  • Clinically relevant vascular disorders including but not limited to peripheral vascular disease or peripheral artery disease.
  • Subjects currently taking anti-coagulants (i.e., Plavix).
  • Current uncontrolled diabetes.
  • History of deep vein thrombosis and pulmonary embolism.
  • Documented coagulation disorders or thromboembolic disease.
  • Any currently active diagnosis of endocrine disorder without satisfactory treatment (ie hyperthyroidism without stable treatment).
  • Human growth hormone medications.
  • Primary synovial neoplasm.
  • Previous malignancy in the bones, cartilage, fat or muscle of the treated limb; or any other location within the past 3 years (except non-melanoma skin cancer) .
  • Currently participating, or have participated in any other clinical trial within 3 months prior to the Screening Visit.
  • Psychiatric or cognitive impairment, that in the opinion of the investigator, would interfere with the subject’s ability to comply with the study requirements or measurements( e.g., Alzheimer’s Disease).
  • Known current or recent history of illicit drug or alcohol abuse (including steroid use), or dependence defined as the continued use of alcohol/drugs despite the development of social, legal or health problems.
  • Unable to undergo magnetic resonance imaging (MRI).
  • Sensitivity to bovine materials; or history of host reaction/rejection.
  • Subjects receiving ongoing Workman’s Compensation or other liability injury claim.

 

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

7783562

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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