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NOVOCART 3D vs Microfracture for Knee Cartilage Defects (N3D Trial)

Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post treatment
Awards & highlights

N3D Trial Summary

This trial will compare two knee surgery treatments: NOVOCART 3D and Microfracture. They will be evaluated based on pain levels and function of the knee. Safety will also be monitored.

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.Check my eligibility
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.See study design
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.

N3D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a knee cartilage injury between 2-6 cm2.
Select...
I am older than 18 years.

N3D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain
Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain

N3D 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

Find a Location

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

Media Library

Microfracture Clinical Trial Eligibility Overview. Trial Name: NCT01957722 — Phase 3
Articular Cartilage Defects Research Study Groups: NOVOCART 3D, Microfracture
Articular Cartilage Defects Clinical Trial 2023: Microfracture Highlights & Side Effects. Trial Name: NCT01957722 — Phase 3
Microfracture 2023 Treatment Timeline for Medical Study. Trial Name: NCT01957722 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be most likely to benefit from participating in this clinical trial?

"This study is for patients who still have some of their original cartilage and are between 18-65 years old. They plan to admit around 233 people in total."

Answered by AI

Are middle-aged individuals eligible for this research study?

"This study only accepts patients that are between 18 and 65 years old."

Answered by AI

Is there a high chance of NOVOCART 3D causing negative side effects?

"There is both efficacy and safety data from multiple rounds of testing that support NOVOCART 3D's classification as a Phase 3 trial, which our team rates as having a safety level of 3."

Answered by AI

At how many different sites are the organizers of this trial overseeing it?

"To make the clinical trial more accessible to a wider range of patients, it is being hosted at 30 different locations. While some sites are in Jackson, North Logan and Evanston, there are also 27 other centres that may be closer to where you live."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
California
Florida
How old are they?
18 - 65
65+
What site did they apply to?
UCLA
Yampa Valley Medical Center
Mayo Clinic
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried steroids, duralane, other hyroulonic acid injections, look for other methods.
PatientReceived 2+ prior treatments
Both knees have osteoarthritis and I am curious about/interested in cell therapy as a less invasive treatment.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
NOVOCART®3D for Treatment of Articular Cartilage of the Knee
2013. "NOVOCART®3D for Treatment of Articular Cartilage of the Knee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01957722.
All > Minnesota > Utah
~12 spots leftby Dec 2024
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