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
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Aesculap Biologics, LLC
- Enrollment
- 233
- Locations
- 35
- Primary Endpoint
- Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
NOVOCART 3D
Scaffold assisted autologous chondrocyte Implant
Intervention: NOVOCART 3D (Biological)
Microfracture
considered a typical treatment for articular cartilage repair
Intervention: Microfracture (Procedure)
Outcomes
Primary Outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain
Time Frame: 24 months post treatment
As measured by a change in KOOS (pain subdomain) score at 24 months from baseline
Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain
Time Frame: 24 months post treatment
As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline
Secondary Outcomes
No secondary outcomes reported