Articular Cartilage of the Femoral Condyle Between 2-6cm2Phase 3N3DNCT01957722
NOVOCART®3D for Treatment of Articular Cartilage of the Knee
A Phase 3 study testing Microfracture and NOVOCART 3D in people with Articular Cartilage of the Femoral Condyle Between 2-6cm2, run by Aesculap Biologics, LLC at 35 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Articular Cartilage of the Femoral Condyle Between 2-6cm2
- What is being tested?
- Microfracture and NOVOCART 3D
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Dec 2013to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 years old
- Isolated articular cartilage lesions on the femoral condyle 2-6 cm2
- Minimum score on the KOOS questionnaire
Who cannot join
- 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.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States30 sites
University of Michigan
Ann Arbor, Michigan, 48106
St. Luke'S University Health Network
Bethlehem, Pennsylvania, 18015
Tria Orthopaedic Center
Bloomington, Minnesota, 55431
Tenet Florida Physician Services
Boca Raton, Florida, 33433
University of Virginia
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
University of Missouri Healthcare
Columbia, Missouri, 65212
Ohio State University Sports Medicine
Columbus, Ohio, 43221
Cu Sports Medicine
Denver, Colorado, 80222
Northshore University Health System
Evanston, Illinois, 60201
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Clinical Research Solutions
Jackson, Tennessee, 38305
Grossmont Orthopaedic Medical Group
La Mesa, California, 91942
University of Kentucky
Lexington, Kentucky, 40536
UCLA
Los Angeles, California, 90095
The Orthopaedic Center of Central Virginia Inc
Lynchburg, Virginia, 24501
Saint Alphonsus Medical Group
Meridian, Idaho, 83642
Ochsner Health System
New Orleans, Louisiana, 70121
Mount Sinai Faculty Practice Associates
New York, New York, 10029
Plancher Orthopaedics & Sports Medicine
New York, New York, 10128
Alpine Orthopaedics
North Logan, Utah, 84341
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Allegheny - Singer Research Institute
Pittsburgh, Pennsylvania, 15212
Long Island Bone and Joint Llp
Port Jefferson, New York, 11777
Stanford Medicine
Redwood City, California, 94063
Advanced Orthopaedics
Richmond, Virginia, 23294
Mayo Clinic
Rochester, Minnesota, 55905
Yampa Valley Medical Center
Steamboat Springs, Colorado, 80487
Tulsa Bone and Joint Associates
Tulsa, Oklahoma, 74146
Paley Orthopedic and Spine Institute
West Palm Beach, Florida, 33407
Canada5 sites
University of Alberta
Edmonton, Alberta, T6G 2R3
Dalhousie University
Halifax, Nova Scotia, B3H 2E1
St. Josephs Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Lawson Health Research Institute
London, Ontario, N6C 2R5
Simon Fraser Orthopaedic Fund
Surrey, British Columbia, V3T 0H1
About this study
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
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.
Read the 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.
- Being tested
- Microfracture, NOVOCART 3D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrofractureProcedure or surgery
Surgical procedure which creates a marrow clot in the prepare cartilage defect.
NOVOCART 3DBiological
combination product- biologic (autologous chondrocytes) /device (scaffold) implant
| Study group | Role | What they receive |
|---|---|---|
| NOVOCART 3D | Experimental | Scaffold assisted autologous chondrocyte Implant Receives: Biological: NOVOCART 3D |
| Microfracture | Active comparator | considered a typical treatment for articular cartilage repair Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain
As measured by a change in KOOS (pain subdomain) score at 24 months from baseline
Measured: 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
Measured: 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage of the Femoral Condyle Between 2-6cm2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Spiro, PhD, Study director, Octane Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957722
- Sponsor's protocol ID
- AAG-G-H-1220
- Acronym
- N3D
- Status last verified
- Mar 2025
- First submitted
- 17 Sep 2013
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01957722
- Acronym / sponsor ID
- N3D / AAG-G-H-1220
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Aesculap Biologics, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOVOCART 3D | Experimental | Biological: NOVOCART 3DScaffold assisted autologous chondrocyte Implant |
| Microfracture | Active comparator | Procedure: Microfractureconsidered a typical treatment for articular cartilage repair |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 18 years old
- Isolated articular cartilage lesions on the femoral condyle 2-6 cm2
- Minimum score on the KOOS questionnaire
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrofractureSurgical procedure which creates a marrow clot in the prepare cartilage defect. | Procedure or surgery | Microfracture |
| NOVOCART 3Dcombination product- biologic (autologous chondrocytes) /device (scaffold) implant | Biological | NOVOCART 3D |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Spiro, PhD study director
Octane Biotherapeutics, Inc.
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Microfracture and NOVOCART 3D in people with Articular Cartilage of the Femoral Condyle Between 2-6cm2, run by Aesculap Biologics, LLC at 35 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain (time frame: 24 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.