Clinical trial NCT01957722: NOVOCART®3D for Treatment of Articular Cartilage of the Knee
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Articular Cartilage of the Femoral Condyle Between 2-6cm2
Lead sponsor: Aesculap Biologics, LLC
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.

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 or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain
timeFrame: 24 months post treatment
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain
timeFrame: 24 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Grossmont Orthopaedic Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Redwood
country: United States
facility: Stanford Medicine
state: California
city: Denver
country: United States
facility: Cu Sports Medicine
state: Colorado
city: Steamboat Springs
country: United States
facility: Yampa Valley Medical Center
state: Colorado
city: Boca Raton
country: United States
facility: Tenet Florida Physician Services
state: Florida
city: West Palm Beach
country: United States
facility: Paley Orthopedic and Spine Institute
state: Florida
city: Meridian
country: United States
facility: Saint Alphonsus Medical Group
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Bloomington
country: United States
facility: Tria Orthopaedic Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Healthcare
state: Missouri
city: New York
country: United States
facility: Mount Sinai Faculty Practice Associates
state: New York
city: New York
country: United States
facility: Plancher Orthopaedics & Sports Medicine
state: New York
city: Port Jefferson
country: United States
facility: Long Island Bone and Joint Llp
state: New York
city: Columbus
country: United States
facility: Ohio State University Sports Medicine
state: Ohio
city: Tulsa
country: United States
facility: Tulsa Bone and Joint Associates
state: Oklahoma
city: Bethlehem
country: United States
facility: St. Luke'S University Health Network
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny - Singer Research Institute
state: Pennsylvania
city: Jackson
country: United States
facility: Clinical Research Solutions
state: Tennessee
city: North Logan
country: United States
facility: Alpine Orthopaedics
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Lynchburg
country: United States
facility: The Orthopaedic Center of Central Virginia Inc
state: Virginia
city: Richmond
country: United States
facility: Advanced Orthopaedics
state: Virginia
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Surrey
country: Canada
facility: Simon Fraser Orthopaedic Fund
state: British Columbia
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Josephs Healthcare Hamilton
state: Ontario
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
Study officials:
affiliation: Octane Biotherapeutics, Inc.
name: Robert Spiro, PhD
role: STUDY_DIRECTOR
References: