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Neocartilage Implant to Treat Cartilage Lesions of the Knee

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ClinicalTrials.gov Identifier: NCT01400607
Recruitment Status : Terminated (Poor enrollment)
First Posted : July 22, 2011
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
ISTO Technologies, Inc.

Tracking Information
First Submitted Date  ICMJE July 20, 2011
First Posted Date  ICMJE July 22, 2011
Last Update Posted Date August 31, 2017
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
Knee Injury and Osteoarthritis Outcomes Scores (KOOS) [ Time Frame: 36 months ]
Knee Injury and Osteoarthritis Outcomes Scores (KOOS) Pain and Function in Daily Living (ADL) subscales.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01400607 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
  • IKDC Knee Examination [ Time Frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years ]
  • Subject reported questionnaires [ Time Frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years ]
    Various questionnaires are required to be completed by the subject before and after treatment throughout the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
  • IKDC Knee Examination [ Time Frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years ]
  • Subject reported questionnaires [ Time Frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years ]
    Various questionsaires are required to be completed by the subject before and after treatment throughout the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neocartilage Implant to Treat Cartilage Lesions of the Knee
Official Title  ICMJE Randomized Controlled Trial to Evaluate the Efficacy of a Neocartilage Implant in the Management of ICRS Grade 3 to 4 Articular Cartilage Lesions of the Knee
Brief Summary ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment.
Detailed Description In the United States alone, more than 500,000 cartilage lesions per year require some treatment to reduce pain, restore joint mobility, and prevent further damage caused by the progression of osteoarthritis. The lack of effective cartilage repair approaches or products for restoration of defective articular cartilage to its native, hyaline morphology only continues to exacerbate the incidence of osteoarthritis as these initial defects enlarge and degrade over a 10 to 20 year period. The repair of cartilage, especially in the knee, remains a formidable clinical challenge. Regenerative medicine approaches to cartilage repair have only begun to be explored as possible options and there is a clear trend toward biological solutions for the repair and regeneration of damaged or diseased articular cartilage. The study was designed to compare how well the Neocartilage Implant works against the microfracture therapy, a widely used and accepted cartilage repair therapy. Data to be collected include Pain and Function in Daily Living scores, symptoms, Function in Sports and Recreation, and Knee Related Quality of Life. Additionally, MRI and X-rays will be collected to evaluate the cartilage repair progress. These assessments will be used through the five years of post-operative follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Articular Cartilage Disorder
  • Degeneration; Articular Cartilage
  • Chronic Cartilage Injury
  • Acute Cartilage Injury
  • Defect of Articular Cartilage
Intervention  ICMJE
  • Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)
    The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.
    Other Name: RevaFlex
  • Other: Microfracture
    Marrow stimulation using the microfracture technique; performed arthroscopically
    Other Name: marrow stimulation
Study Arms  ICMJE
  • Active Comparator: Neocartilage Implant
    Neocartilage Implant surgically implanted and affixed to subchondral bone using commercial fibrin during mini-open knee arthrotomy.
    Intervention: Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)
  • Microfracture
    Standard of care cartilage repair technique.
    Intervention: Other: Microfracture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 7, 2016)
14
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2011)
225
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Generally, the following inclusion criteria must be met, however, this is not a complete list.

  • Male or Female between the ages of 18 and 60
  • (1) or (2) articular cartilage lesions of the distal femur ranging in no more than 5 cm2 each
  • Ipsilateral knee compartment has intact menisci (or meniscectomized remnant with > 5mm wide rim) and stable ligaments in the affected knee
  • 3 months out from initiation of conservative non-surgical management (e.g.hyaluronic acid injection, activity modification) or previous minimal surgical intervention (e.g., arthroscopic lavage, debridement) or 12 months out from marrow stimulation for this condition

Exclusion Criteria:

Generally, if a potential participant meets any of the following criterions, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.

  • Osteoarthritis
  • Rheumatoid arthritis
  • History of septic or reactive arthritis
  • Gout or a history of gout or pseudo-gout in the affected knee
  • Osteochondritis dissecans or osteochondral lesions of the knee with bone loss > 6mm deep
  • Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface)
  • Associated damage to the underlying subchondral bone requiring an osteochondral graft
  • Is pregnant or breast-feeding
  • Has a BMI > 35 (kg/m2)
  • Has prior total meniscectomy of either knee
  • Has received, within the past three months, intra-articular hyaluronic acid therapy, or steroid therapy
  • Has more than two clinically relevant chondral lesion(s) on the index knee
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01400607
Other Study ID Numbers  ICMJE ISTO NEO-01-09-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ISTO Technologies, Inc.
Study Sponsor  ICMJE ISTO Technologies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michaela Purcell ISTO Technologies, Inc.
PRS Account ISTO Technologies, Inc.
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP