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Neocartilage Implant Phase III Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
ISTO Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01400607
First received: July 20, 2011
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

ISTO Technologies, Inc. is proposing a Phase III 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.


Condition Intervention Phase
Articular Cartilage Disorder
Degeneration; Articular Cartilage
Chronic Cartilage Injury
Acute Cartilage Injury
Defect of Articular Cartilage
 Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)
Other: Microfracture
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pivotal, Adaptive Phase III 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ISTO Technologies, Inc.:

Primary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcomes Scores (KOOS) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Knee Injury and Osteoarthritis Outcomes Scores (KOOS) Pain and Function in Daily Living (ADL) subscales.


Secondary Outcome Measures:
  • IKDC Knee Examination [ Time Frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years ] [ Designated as safety issue: No ]
  • Subject reported questionaires [ Time Frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years ] [ Designated as safety issue: No ]
    Various questionsaires are required to be completed by the subject before and after treatment throughout the study.


Estimated Enrollment: 225
Study Start Date: July 2011
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neocartilage Implant
Neocartilage Implant surgically implanted and affixed to subchondral bone using commercial fibrin during mini-open knee arthrotomy.
 Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)
The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.
Other Name: DeNovo ET
Microfracture
Standard of care cartilage repair technique.
 Other: Microfracture
Marrow stimulation using the microfracture technique; performed arthroscopically
Other Name: marrow stimulation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 pseudogout 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400607

Locations
United States, California
Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, United States, 90045
Santa Monica Orthopaedic & Sports Medicine Group
Santa Monica, California, United States, 90404
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, New York
Insall Scott Kelly Institute for Orthopaedics & Sports Medicine
New York, New York, United States, 10065
Hospital for Special Surgery -Sports Medicine and Shoulder Service
New York, New York, United States, 10021
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
The Ohio State University Sports Medicine Center
Columbus, Ohio, United States, 43221
United States, South Carolina
The Hawkins Foundation
Greenville, South Carolina, United States, 29615
United States, Texas
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
ISTO Technologies, Inc.
Zimmer, Inc.
Investigators
Study Director: Ed Margerrison, PhD Zimmer, Inc.
  More Information

No publications provided

Responsible Party: ISTO Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01400607     History of Changes
Other Study ID Numbers: ISTO NEO-01-09-01
Study First Received: July 20, 2011
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ISTO Technologies, Inc.:
cartilage
knee surgery
cartilage injury
knee pain
cartilage repair
cartilage damage
cartilage lesion
cartilage defect
articular cartilage lesion
 articular cartilage defect
juvenile
cells
ISTO Technologies
Zimmer
DeNovo
Neocartilage
DeNovo ET

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 21, 2013