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NOVOCART 3D vs Microfracture for Knee Cartilage Defects (N3D Trial)
Phase 3
Waitlist Available
Research Sponsored by Aesculap Biologics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Isolated articular cartilage lesions on the femoral condyle 2-6 cm2
Greater than 18 years old
Must not have
Instability of the knee joint
Immune suppression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post treatment
Awards & highlights
Summary
This trial compares two methods for treating damaged knee cartilage. It aims to see which method better reduces pain and improves knee function. The study will monitor patients over several years to evaluate safety and effectiveness.
Who is the study for?
This trial is for adults over 18 with specific knee cartilage defects between 2-6 cm². Participants must have a certain level of pain and dysfunction as measured by the KOOS questionnaire. It's not for those with arthritis, unstable knees, immune issues, prior similar knee surgeries (except debridement/lavage after three months), bone diseases, degenerative conditions that affect healing or evaluation, or autoimmune diseases.
What is being tested?
The study compares NOVOCART 3D (a tissue-engineered cartilage implant) to Microfracture surgery (a technique where small holes are made in the bone beneath the damaged cartilage to stimulate new growth). The goal is to see which treatment better improves pain and function in the knee.
What are the potential side effects?
While specific side effects aren't listed here, generally such procedures may cause joint pain, swelling, infection risk at the surgical site, blood clots in leg veins or lungs post-surgery and potential complications related to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a knee cartilage injury between 2-6 cm2.
Select...
I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My knee is unstable.
Select...
I have a weakened immune system.
Select...
I do not have any conditions that could affect my healing or the assessment of my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain
Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NOVOCART 3DExperimental Treatment1 Intervention
Scaffold assisted autologous chondrocyte Implant
Group II: MicrofractureActive Control1 Intervention
considered a typical treatment for articular cartilage repair
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Tissue-engineered cartilage grafts, such as NOVOCART 3D, use bioengineered scaffolds seeded with chondrocytes or stem cells to regenerate durable and functional cartilage by mimicking natural cartilage structure. In contrast, the microfracture technique creates small fractures in the subchondral bone to release bone marrow cells, forming a less durable fibrocartilaginous repair tissue.
Understanding these mechanisms helps patients and doctors choose the most suitable treatment based on defect severity, desired outcomes, and long-term joint health.
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Who is running the clinical trial?
Aesculap Biologics, LLCLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Articular Cartilage Defects
30 Patients Enrolled for Articular Cartilage Defects
Robert Spiro, PhDStudy DirectorAesculap Biologics
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Articular Cartilage Defects
30 Patients Enrolled for Articular Cartilage Defects
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a certain score on the KOOS questionnaire.I have a knee cartilage injury between 2-6 cm2.My knee is unstable.I have a bone condition.I am older than 18 years.You have an autoimmune disease.I have a weakened immune system.I have had specific knee surgeries like mosaicplasty, but it's been over 3 months.I have arthritis.I do not have any conditions that could affect my healing or the assessment of my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: NOVOCART 3D
- Group 2: Microfracture
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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