Traumatic Articular Cartilage Defects in the Knee JointPhase 3N3DNCT01656902
Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture in Knee Cartilage Defects
A Phase 3 study testing NOVOCART® 3D plus and Microfracture in people with Traumatic Articular Cartilage Defects in the Knee Joint, run by Tetec AG at 35 sites in 10 countries.
Trial summary
In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation technique) is compared to standard of care therapy (microfracture) to treat traumatic cartilage defects of the knee for efficacy and safety. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Traumatic Articular Cartilage Defects in the Knee Joint
- What is being tested?
- NOVOCART® 3D plus and Microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 35 sitesin 10 countries
- Study dates
- May 2013to 28 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is between 18 and 65 years old at screening OR (in selected countries only) is a pediatric patient (14-17 years old) with closed epiphyseal growth plate (confirmation of closure of epiphyseal growth plate of the index knee by x-ray or MRI required).
- Patient has a localized articular cartilage defect of the femoral condyle or the trochlea of the knee. 2 localized cartilage defects are accepted if the total defect size is ≤ 6 cm2 and the size of each individual lesion is ≥ 2 cm2, both cartilage defects are located at the femoral condyle and/or the trochlea and both cartilage defects are to be treated with NOVOCART 3D plus or microfracture.
- Patient has a defect size is between 2 and 6 cm2. Note: defect size can be estimated by MRI at visit 1 if no data is available from medical history.
- Patient has an intact articulating joint surface (not higher than Grade 2 International Cartilage Repair Society classification, no kissing lesions). Note: ICRS classification can be estimated by MRI at visit 1 if no data is available from medical history.
- Patient has an intact meniscus; a maximum of 50% resection is allowed. Note: status of meniscus can be estimated at visit 1 if no data is available from medical history.
- Patient has a stable knee joint or sufficiently reconstructed ligaments. If not, ligament repair must be done before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
Show all 11Show fewer
- Patient has free range of motion of the affected knee joint or ≤ 10° of extension and flexion loss.
- Patient has a defect-grade of III or IV according to the ICRS classification. Note: ICRS classification can be estimated by MRI at visit 1 if not data is available from medical history.
- Patient has a baseline score of 60/100 on the 2000 International Knee Documentation Committee (IKDC) subjective knee evaluation.
- Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow-up visits and assessments and postoperative rehabilitation regimen.
- Mandatory for France only: Patient benefits of a health insurance regimen.
Who cannot join
- Patient is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
- Patient is unable to undergo magnetic resonance imaging (MRI).
- Patient has prior surgical treatment of the target knee using mosaicplasty, autologous chondrocyte transplantation and/or microfracture. Note: prior diagnostic arthroscopies with debridement and lavage are acceptable. Ligament repair is accepted, if performed before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
- Patient has radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade > 2 (see Appendix A).
- Patient has chronic inflammatory arthritis and/or infectious arthritis.
- Patient has joint space narrowing > 1/3 in the target knee when compared to the other knee or smaller than 3 mm joint space measured on x-ray.
Show all 37Show fewer
- Patient has malalignment (valgus- or varus-deformity) in the target knee. Note: In suspected cases, the mechanical axis must be established radiographically by complete leg imaging in standing position and in a.p. or rather p.a. projection. The Mikulicz line is not allowed to deviate more than 5 mm of the eminentia intercondylaris. If alignment is necessary, surgery has to be performed before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
- Patient has prior surgical treatment of clinical relevance of the target knee.
- Patient has an osteochondral defect.
- Patient has bilateral lower limb pain or low back pain.
- Patient has a known systemic connective tissue disease.
- Patient has a current uncontrolled diabetes.
- Patient has a known history of autoimmune disease.
- Patient has a known history of immunological suppressive disorder or is taking immunosuppressants.
- Patient is currently systemically or intra-articularly taking steroids and/or has used steroids within the last 30 days prior to screening visit 1.
- The patient has a history of HIV/AIDS.
- The patient has a history of syphilis (Treponema pallidum).
- The patient has an active hepatitis B or C infection with verified antigens. Note: Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded.
- The patient has at the site of surgery an active systemic or local microbial infection, eczematization or inflammable skin alterations (including protozoonosis: Babesiosis, Trypanosomiasis (e.g. Chagas-Disease), Leishmaniasis, persistent bacterial infections, like Brucellosis, spotted and typhus fever, other Rickettsiosis, Leprosy, Recurrent Fever, Melioidosis or Tularaemia).
- Patient has a known history of cancer within the past 5 years.
- Patient has a known history of osteoporosis; also patients with primary hyperparathyroidism or hyperthyroidism without satisfactory treatment, chronic renal failure or patients with prior pathological fractures independent of the genesis are excluded.
- Patient has any degenerative muscular or neurological condition that would interfere with evaluation of outcome measures including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis (MS).
- Patient has a body mass index (BMI) higher than 35 kg/m2.
- Patient is a woman who is pregnant or lactating. Note: contraception is indicated for female patients of childbearing potential until the day of cartilage treatment. Female patients who are unwilling to practice a medically acceptable method of birth control until the day of cartilage treatment cannot be included.
- Patient is currently participating, or has participated in any other clinical study within 3 months prior to the screening visit.
- Patient has known current or recent history of illicit drug or alcohol abuse or dependence
- Patient has psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the patient's ability to comply with the study requirements, e.g., Alzheimer's disease.
- Patient has any other condition, which, in the opinion of the investigator, would make the patient unsuitable for the study.
- Patient has a history of HTLV.
- Intra-operative Inclusion Criteria:
- Patient is not pregnant as confirmed by urine pregnancy test before arthroscopy.
- Patient has a localized articular cartilage defect of the femoral condyle or the trochlea of the knee. 2 localized cartilage defects are accepted if the total defect size is up to 6 cm2 and the size of each individual lesion is at least 2 cm2, both cartilage defects are located at the femoral condyle and/or the trochlea and both cartilage defects are to be treated with NOVOCART 3D plus or microfracture.
- Patient has a defect size of 2 to 6 cm2 post-debridement.
- Patient has an intact articulating joint surface (at least (or higher) Grade 2 International Cartilage Repair Society classification) no kissing lesions).
- Patient has an intact meniscus; a maximum of 50% resection is allowed (no indication for concurrent meniscus transplant).
- Patient has a stable knee joint or sufficiently reconstructed ligaments. If not, ligament repair must be done during or within 6 weeks after cartilage treatment (ACT/microfracture).
- Patient has a defect grade of III or IV according to the ICRS classification.
Trial locations and contacts
35 sites in 10 countries.
35 sites in 10 countries
Czechia7 sites
Fakultni nemocnice Brno - Ortopedicka klinika
Brno, 62500
Urazova nemocnice v Brne - Traumatologie
Brno, 66250
NH Hospital, a.s., Ortopedicke oddeleni nemocnice Horovice
Hořovice, 26831
Fakultni nemocnice Hradec Kralove - Ortopedicka klinika
Hradec Králové, 50005
Pardubicka nemocnice
Pardubice, 53203
Fakultni nemocnice v Motole
Prague, 15006
UVN - Vojenska fakultni nemocnice Praha
Prague, 16902
Hungary5 sites
Uzsoki utcai Kórház
Budapest, 1145
Petz Aladár Megyei Oktató Kórház
Győr, 9024
B-A-Z Megyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, 3526
Markusovszky Egyetemi Oktatókórház
Szombathely, 9700
Kastélypark Klinika
Tata, 2890
Lithuania5 sites
Kaunas clinical hospital
Kaunas, 44320
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, 50009
Klaipeda university hospital
Klaipėda, 92288
JSC "Kardiolita"
Vilnius, 05263
JSC "SK Impeks Medicinos Diagnostikos Centras"
Vilnius, 10318
Poland5 sites
Szpital sw. Lukasza BGL Sp z o.o. S.K.A.
Bielsko-Biala, 43309
Samozdzielny Publiczny Zaklad Opieki Zdrowotnej Miejskiego Szpitala Zespolonego
Częstochowa, 42200
Szpital Angelius
Katowice, 40611
Samozdzielny Publiczny Wojewodzki Szpital Chirurgii Urazowej
Piekary Śląskie, 41940
Centrum Medycyny Sportowej
Warsaw, 02034
France4 sites
Hôpital Ambroise Paré - Service de Chirurgie Orthopedique et Traumatologie
Boulogne-Billancourt, 92104
Polyclinique Saint-Roch
Montpellier, 34075
Clinique V - Clinique du Sport
Paris, 75005
CHU de Saint-Etienne Hôpital Nord - Service orthopedie et traumatologie
Saint-Priest-en-Jarez, 42270
Germany4 sites
Universitaetsklinikum Freiburg - Klinik fuer Orthopaedie
Freiburg im Breisgau, 79106
Theresienkrankenhaus
Mannheim, 68165
Orthopädische Klinik und Poliklinik der LMU München
München, 81377
Universitätsklinikum Regensburg
Regensburg, 93042
Latvia2 sites
Hospital of Traumatology and Orthopaedics, Trauma Department
Riga, 1005
Orto Clinic
Riga, 1005
About this study
Official title: A Prospective Randomized Controlled Multicenter Phase-III Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D Plus Compared to the Standard Procedure Microfracture in the Treatment of Articular Cartilage Defects of the Knee
In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation technique) is compared to standard of care therapy (microfracture) to treat traumatic cartilage defects of the knee for efficacy and safety. The investigated study treatment NOVOCART 3D plus is a biphasic biological scaffold which contains cultivated chondrocytes derived from the patient in a previous tissue harvest procedure. Allocation to the study treatment is done by randomization in a ration of 2:1 in favor to ACI (investigational product). Follow-up data for efficacy is collected for 2 years: follow-up visits are performed 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months after treatment; additional data for safety will be collected for up to 5 years: 36, 48, and 60 months after treatment. The study involves knee surgery (by arthroscopy, or mini-arthrotomically for implantation surgery), and blood withdrawal for safety within the first year after treatment. Initial imaging is required at baseline. Optional MRI imaging and biomarker collection is done as substudy at specific sites only.
Read the detailed description
For the cartilage cell product NOVOCART® 3D plus, which is used in the study described here, the company TETEC AG obtained an expanded production authorization from the medication monitoring authorities in compliance with Section 13, Para. 1 of the Medicinal Products Act in 2003. This entitles TETEC AG to produce the pharmaceutical product and already distribute it. More than 6000 patients were already successfully treated with NOVOCART® 3D in Europe since 2003. In order to obtain a general market authorization for NOVOCART® 3D plus, this control group study is conducted, in which the superiority of the safety and effectiveness of carrier-bound Autologous Chondrocyte Transplantation with NOVOCART® 3D plus compared to the standard of care microfracture surgery needs to be proven. This study further aims at developing and validating known and new biologic markers for the quality and clinical efficacy of the product as requested in the context of identity, purity and potency characteristics of the medicinal/investigational product.
The patients will receive one of the therapeutic procedures in the study. The treatment procedure which will be used will be decided by a previously specified randomization process. This type of study meets the high quality requirements of the statutorily specified safety and quality regulations which are also referred to as "Good Clinical Practice" (GCP). The probability of the patient being allocated to one of the two treatments is 2:1; that is, an approx. 67% probability of therapy with NOVOCART® 3D plus and an approx. 33% probability of therapy with microfracture. Neither the patient, nor the investigator will be able to influence the treatment assignment.
Patients will be screened for eligibility at the Screening Visit. Each patient will remain in the study for 24 months post-implant for the effectiveness assessments, and then an additional three years to complete the planned post-market phase. Each patient will be in the study for up to five years.
Cells and tissues collected from this study will be used in other in vitro-controlled experiments aimed at developing and validating known and novel biologic markers to quantify cell quality in the context of identity, purity and potency. Prognostic values of these biologic markers will be examined by correlating them with clinical data collected in this study.
- Being tested
- NOVOCART® 3D plus, Microfracture
- Keywords
- Autologous Chondrocyte Transplantation, NOVOCART 3D plus, knee joint pain, safety, efficacy, treatment, TETEC, cartilage, ACT, cartilage repair, tissue, MOCART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVOCART® 3D plusDrug
Also called Matrix-associated autologous chondrocyte implantation
Two-Step intervention: 1) cartilage cells are collected from the patient during arthroscopy 2) collected cartilage cells are cultivated in a sterile environment, seeded in an organic matrix scaffold and implanted into the defect location (knee, femur)
MicrofractureProcedure or surgery
Also called Microfracture according to Steadman
single-step treatment: defect location (knee, femur) is debrided, then bone plate is drilled mechanically to allow cells from the bone marrow to move to the defect location and to develop a scar tissue
| Study group | Role | What they receive |
|---|---|---|
| N3D plus | Experimental | NOVOCART® 3D plus (Autologous Chondrocyte Transplantation System) Receives: Drug: NOVOCART® 3D plus |
| Microfracture | Active comparator | Microfracture is the standard care surgery. Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective IKDC score
The primary endpoint is the change from baseline in the "2000 International Knee Documentation Committee" (IKDC) subjective score to 24-month visit.
The IKDC will be recorded for NOVOCART® 3D plus and microfracture patients at baseline visit 1 and at the 6 weeks, 3-, 6-, 12-, 24-, 36-, 48,- and 60-month follow-up assessments.
Measured: Baseline assessment to 24-month follow-up assessment
Secondary outcomes (8)
IKDC objective physician score
The IKDC objective physician score will be recorded for both arms at baseline visit 1 and at the 6 weeks, 3-, 6-, 12-, 24-, 36-, 48,- and 60-month follow-up assessments. A sequentially rejecting, hierarchical test procedure will be employed to test these secondary endpoints in the a-priori defined order given here after the test primary efficacy variable was passed.
The change from baseline to the 24-month visit in the IKDC objective physician score and from baseline to the 24-month visit will be evaluated.
Measured: Baseline assessment to 24-month follow-up assessment
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS will be recorded for both arms at baseline visit 1 and at the 6 weeks, 3-, 6-, 12-, 24-, 36-, 48,- and 60-month follow-up assessments.
A sequentially rejecting, hierarchical test procedure will be employed to test these secondary endpoints in the a-priori defined order given here after the test primary efficacy variable was passed. The change from baseline to 24-month visit in the Knee Injury and Osteoarthritis Outcome Score (KOOS) and from baseline to 24-month visit will be evaluated.
Measured: Baseline assessment to 24-month follow-up assessment
MOCART Score (MRI)
Another secondary efficacy endpoint is the in vivo performance (grading on quality of cartilage fill) measured by the change from baseline to the 36-month assessment of the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score. These assessments will be performed on a subset of patients (64 in NOVOCART and 32 in microfracture arm).
The MRI will be recorded at 3, 12, 24 and 60 months follow-up visit.
Measured: Baseline assessment to the 24-month assessment
Health-related quality of life as measured by the SF-36 survey
Another secondary efficacy endpoint is the change from baseline to the 24-month visit in the SF-36 to measure clinical utility and summarize health-related quality-of-life and cost-effectiveness. The SF-36 will be recorded for NOVOCART® 3D plus and microfracture patients at baseline visit 1 and at the 6 weeks, 3-, 6-, 12-, 24-, 36-, 48,- and 60-month follow-up assessments.
Measured: Baseline assessment to 24-month follow-up assessment
Surgical time (cut-to-suture time)
The surgical time will be measured in minutes and recorded for NOVOCART® 3D plus patients at arthroscopy (>= 1 day after screening) and transplantation (24 +-5 days post-arthroscopy); for microfracture patients surgical time will be measured in minutes and recorded at arthroscopy (>= 1 day after screening).
Measured: Transplantation (24 +-5 days post-arthroscopy) and/or arthroscopy (>= 1 day after screening), depending on the study arm
Length of incision
The length of incision will be measured in cm and recorded for NOVOCART® 3D plus patients at transplantation (24 +-5 days post-arthroscopy)
Measured: Only for verum group at transplantation (24 +-5 days post-arthroscopy)
Any unanticipated adverse event
Event descriptions, onset, resolution dates, relationship to the IP and procedures of any AEs will be recorded. Each event will be categorized by seriousness and intensity to facilitate complete safety reporting throughout the trial.
While comparisons between treatment groups can be made for each class of AE, there is no statistical hypothesis governing acceptance of this endpoint at the end of the clinical study because of the different AE profiles associated with the two treatment arms.
Measured: Baseline assessment up to 60-months follow-up assessment
Treatment Failure
Any event related to a diagnosed failure of the study treatment
Measured: From completion of study treatment until 60-months follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startMay 2013
- Primary completion6 Mar 2020
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Articular Cartilage Defects in the Knee JointStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Angele, Prof., Principal investigator, Universitätsklinikum Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656902
- Sponsor's protocol ID
- AAG-G-H-1202
- Acronym
- N3D
- Status last verified
- Oct 2021
- First submitted
- 20 Jul 2012
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koenig FRM, Vetchy V, Wollner G, Kern M, Raudner M, Janacova V, Juras V, Szomolanyi P, Schreiner MM, Trattnig S. Five-Year Clinical and MRI-Based Outcomes After Cartilage Repair With or Without ACL Reconstruction: Worse Clinical Outcome after ACL Reconstruction Does not Affect Cartilage Repair Tissue Quality. Cartilage. 2026 Sep;17(3):368-377. doi: 10.1177/19476035251362433. Epub 2025 Aug 8.
PubMed 40778441Gaissmaier C, Angele P, Spiro RC, Kohler A, Kirner A, Niemeyer P. Hydrogel-Based Matrix-Associated Autologous Chondrocyte Implantation Shows Greater Substantial Clinical Benefit at 24 Months Follow-Up than Microfracture: A Propensity Score Matched-Pair Analysis. Cartilage. 2025 Jun;16(2):139-149. doi: 10.1177/19476035241235928. Epub 2024 Mar 19.
PubMed 38501741
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Multicenter Phase-III Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D Plus Compared to the Standard Procedure Microfracture in the Treatment of Articular Cartilage Defects of the Knee
- ClinicalTrials.gov ID
- NCT01656902
- Acronym / sponsor ID
- N3D / AAG-G-H-1202
- Keywords
- Autologous Chondrocyte Transplantation, NOVOCART 3D plus, knee joint pain, safety, efficacy, treatment, TETEC, cartilage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Tetec AGIndustry (pharma, biotech, devices)
- Study start
- May 2013 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 3 Aug 2012 (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.
In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation technique) is compared to standard of care therapy (microfracture) to treat traumatic cartilage defects of the knee for efficacy and safety. The investigated study treatment NOVOCART 3D plus is a biphasic biological scaffold which contains cultivated chondrocytes derived from the patient in a previous tissue harvest procedure. Allocation to the study treatment is done by randomization in a ration of 2:1 in favor to ACI (investigational product). Follow-up data for efficacy is collected for 2 years: follow-up visits are performed 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months after treatment; additional data for safety will be collected for up to 5 years: 36, 48, and 60 months after treatment. The study involves knee surgery (by arthroscopy, or mini-arthrotomically for implantation surgery), and blood withdrawal for safety within the first year after treatment. Initial imaging is required at baseline. Optional MRI imaging and biomarker collection is done as substudy at specific sites only.
Detailed description
For the cartilage cell product NOVOCART® 3D plus, which is used in the study described here, the company TETEC AG obtained an expanded production authorization from the medication monitoring authorities in compliance with Section 13, Para. 1 of the Medicinal Products Act in 2003. This entitles TETEC AG to produce the pharmaceutical product and already distribute it. More than 6000 patients were already successfully treated with NOVOCART® 3D in Europe since 2003. In order to obtain a general market authorization for NOVOCART® 3D plus, this control group study is conducted, in which the superiority of the safety and effectiveness of carrier-bound Autologous Chondrocyte Transplantation with NOVOCART® 3D plus compared to the standard of care microfracture surgery needs to be proven. This study further aims at developing and validating known and new biologic markers for the quality and clinical efficacy of the product as requested in the context of identity, purity and potency characteristics of the medicinal/investigational product.
The patients will receive one of the therapeutic procedures in the study. The treatment procedure which will be used will be decided by a previously specified randomization process. This type of study meets the high quality requirements of the statutorily specified safety and quality regulations which are also referred to as "Good Clinical Practice" (GCP). The probability of the patient being allocated to one of the two treatments is 2:1; that is, an approx. 67% probability of therapy with NOVOCART® 3D plus and an approx. 33% probability of therapy with microfracture. Neither the patient, nor the investigator will be able to influence the treatment assignment.
Patients will be screened for eligibility at the Screening Visit. Each patient will remain in the study for 24 months post-implant for the effectiveness assessments, and then an additional three years to complete the planned post-market phase. Each patient will be in the study for up to five years.
Cells and tissues collected from this study will be used in other in vitro-controlled experiments aimed at developing and validating known and novel biologic markers to quantify cell quality in the context of identity, purity and potency. Prognostic values of these biologic markers will be examined by correlating them with clinical data collected in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N3D plus | Experimental | Drug: NOVOCART® 3D plusNOVOCART® 3D plus (Autologous Chondrocyte Transplantation System) |
| Microfracture | Active comparator | Procedure: MicrofractureMicrofracture is the standard care surgery. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is between 18 and 65 years old at screening OR (in selected countries only) is a pediatric patient (14-17 years old) with closed epiphyseal growth plate (confirmation of closure of epiphyseal growth plate of the index knee by x-ray or MRI required).
- Patient has a localized articular cartilage defect of the femoral condyle or the trochlea of the knee. 2 localized cartilage defects are accepted if the total defect size is ≤ 6 cm2 and the size of each individual lesion is ≥ 2 cm2, both cartilage defects are located at the femoral condyle and/or the trochlea and both cartilage defects are to be treated with NOVOCART 3D plus or microfracture.
- Patient has a defect size is between 2 and 6 cm2. Note: defect size can be estimated by MRI at visit 1 if no data is available from medical history.
- Patient has an intact articulating joint surface (not higher than Grade 2 International Cartilage Repair Society classification, no kissing lesions). Note: ICRS classification can be estimated by MRI at visit 1 if no data is available from medical history.
- Patient has an intact meniscus; a maximum of 50% resection is allowed. Note: status of meniscus can be estimated at visit 1 if no data is available from medical history.
Key exclusion criteria (37 listed)
- Patient is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
- Patient is unable to undergo magnetic resonance imaging (MRI).
- Patient has prior surgical treatment of the target knee using mosaicplasty, autologous chondrocyte transplantation and/or microfracture. Note: prior diagnostic arthroscopies with debridement and lavage are acceptable. Ligament repair is accepted, if performed before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
- Patient has radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade > 2 (see Appendix A).
- Patient has chronic inflammatory arthritis and/or infectious arthritis.
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 |
|---|---|---|
| NOVOCART® 3D plusAlso: Matrix-associated autologous chondrocyte implantationTwo-Step intervention: 1) cartilage cells are collected from the patient during arthroscopy 2) collected cartilage cells are cultivated in a sterile environment, seeded in an organic matrix scaffold and implanted into the defect location (knee, femur) | Drug | N3D plus |
| MicrofractureAlso: Microfracture according to Steadmansingle-step treatment: defect location (knee, femur) is debrided, then bone plate is drilled mechanically to allow cells from the bone marrow to move to the defect location and to develop a scar tissue | Procedure or surgery | Microfracture |
Primary outcome
Subjective IKDC score
Time frame: Baseline assessment to 24-month follow-up assessment
The primary endpoint is the change from baseline in the "2000 International Knee Documentation Committee" (IKDC) subjective score to 24-month visit. The IKDC will be recorded for NOVOCART® 3D plus and microfracture patients at baseline visit 1 and at the 6 weeks, 3-, 6-, 12-, 24-, 36-, 48,- and 60-month follow-up assessments.
8 secondary outcomes
IKDC objective physician score
Time frame: Baseline assessment to 24-month follow-up assessment
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline assessment to 24-month follow-up assessment
MOCART Score (MRI)
Time frame: Baseline assessment to the 24-month assessment
Health-related quality of life as measured by the SF-36 survey
Time frame: Baseline assessment to 24-month follow-up assessment
Surgical time (cut-to-suture time)
Time frame: Transplantation (24 +-5 days post-arthroscopy) and/or arthroscopy (>= 1 day after screening), depending on the study arm
Length of incision
Time frame: Only for verum group at transplantation (24 +-5 days post-arthroscopy)
Any unanticipated adverse event
Time frame: Baseline assessment up to 60-months follow-up assessment
Treatment Failure
Time frame: From completion of study treatment until 60-months follow-up assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 40778441Koenig FRM, Vetchy V, Wollner G, Kern M, Raudner M, Janacova V, Juras V, Szomolanyi P, Schreiner MM, Trattnig S. Five-Year Clinical and MRI-Based Outcomes After Cartilage Repair With or Without ACL Reconstruction: Worse Clinical Outcome after ACL Reconstruction Does not Affect Cartilage Repair Tissue Quality. Cartilage. 2026 Sep;17(3):368-377. doi: 10.1177/19476035251362433. Epub 2025 Aug 8.
- Derived from this study: PubMed 38501741Gaissmaier C, Angele P, Spiro RC, Kohler A, Kirner A, Niemeyer P. Hydrogel-Based Matrix-Associated Autologous Chondrocyte Implantation Shows Greater Substantial Clinical Benefit at 24 Months Follow-Up than Microfracture: A Propensity Score Matched-Pair Analysis. Cartilage. 2025 Jun;16(2):139-149. doi: 10.1177/19476035241235928. Epub 2024 Mar 19.
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.
Peter Angele, Prof. principal investigator
Universitätsklinikum Regensburg
35 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NOVOCART® 3D plus and Microfracture in people with Traumatic Articular Cartilage Defects in the Knee Joint, run by Tetec AG at 35 sites in 10 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 11 inclusion and 37 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: finished, as of the sponsor's last update on 24 Nov 2023. 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 Czechia, Hungary, Lithuania, Poland, France and 5 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjective IKDC score (time frame: Baseline assessment to 24-month follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01656902, which also lists 2 linked publications.
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 24 Nov 2023.