NOVOCART®3D for Treatment of Articular Cartilage of the Knee
N3D
A Phase 3, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared ot Microfracture in the Treatment of Articular Cartilage Defects
1 other identifier
interventional
233
2 countries
35
Brief Summary
This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2013
Longer than P75 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedMarch 21, 2025
March 1, 2025
12 years
September 17, 2013
March 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain
As measured by a change in KOOS (pain subdomain) score at 24 months from baseline
24 months post treatment
Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain
As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline
24 months post treatment
Study Arms (2)
NOVOCART 3D
EXPERIMENTALScaffold assisted autologous chondrocyte Implant
Microfracture
ACTIVE COMPARATORconsidered a typical treatment for articular cartilage repair
Interventions
Surgical procedure which creates a marrow clot in the prepare cartilage defect.
combination product- biologic (autologous chondrocytes) /device (scaffold) implant
Eligibility Criteria
You may qualify if:
- Greater than 18 years old
- Isolated articular cartilage lesions on the femoral condyle 2-6 cm2
- Minimum score on the KOOS questionnaire
You may not qualify if:
- 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 or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Grossmont Orthopaedic Medical Group
La Mesa, California, 91942, United States
UCLA
Los Angeles, California, 90095, United States
Stanford Medicine
Redwood City, California, 94063, United States
Cu Sports Medicine
Denver, Colorado, 80222, United States
Yampa Valley Medical Center
Steamboat Springs, Colorado, 80487, United States
Tenet Florida Physician Services
Boca Raton, Florida, 33433, United States
Paley Orthopedic and Spine Institute
West Palm Beach, Florida, 33407, United States
Saint Alphonsus Medical Group
Meridian, Idaho, 83642, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Northshore University Health System
Evanston, Illinois, 60201, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Ochsner Health System
New Orleans, Louisiana, 70121, United States
University of Michigan
Ann Arbor, Michigan, 48106, United States
Tria Orthopaedic Center
Bloomington, Minnesota, 55431, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Missouri Healthcare
Columbia, Missouri, 65212, United States
Mount Sinai Faculty Practice Associates
New York, New York, 10029, United States
Plancher Orthopaedics & Sports Medicine
New York, New York, 10128, United States
Long Island Bone and Joint Llp
Port Jefferson, New York, 11777, United States
Ohio State University Sports Medicine
Columbus, Ohio, 43221, United States
Tulsa Bone and Joint Associates
Tulsa, Oklahoma, 74146, United States
St. Luke'S University Health Network
Bethlehem, Pennsylvania, 18015, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Allegheny - Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
Clinical Research Solutions
Jackson, Tennessee, 38305, United States
Alpine Orthopaedics
North Logan, Utah, 84341, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
The Orthopaedic Center of Central Virginia Inc
Lynchburg, Virginia, 24501, United States
Advanced Orthopaedics
Richmond, Virginia, 23294, United States
University of Alberta
Edmonton, Alberta, T6G 2R3, Canada
Simon Fraser Orthopaedic Fund
Surrey, British Columbia, V3T 0H1, Canada
Dalhousie University
Halifax, Nova Scotia, B3H 2E1, Canada
St. Josephs Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Lawson Health Research Institute
London, Ontario, N6C 2R5, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Spiro, PhD
Octane Biotherapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2013
First Posted
October 8, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2027
Last Updated
March 21, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share