Cartilage DiseasesNBasicNCT03808623
Non-interventional Study With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee With MAC
An observational study of Cartilage Diseases, run by Tetec AG at 3 sites in 2 countries.
Trial summary
Retrospective, multicenter, single arm, non-interventional study to assess the safety and Performance of NOVOCART Basic and the clinical outcome of MAC with NOVOCART Basic in patients treated for cartilage defects in the knee. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cartilage Diseases
- What is being tested?
- MAC with NOVOCART Basic
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Apr 2018to 24 Jul 2019
- Phase
- Observational
- 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 18 to 55 years
- All sexes
- Adult
Study population: All patients (adult and pediatric) who have received an MAC with NOVOCART® Basic in the knee are eligible for this study, provided that they have given their informed consent for data collection and the involved clinical site has agreed to participate.
Who may be able to join
- for the biological reconstruction of localized full-layer cartilage damage (III and IV degree defects pursuant to the ICRS classification) in the knee joint.
- Treatable defects include:
- Cartilage damage caused by trauma
- Defects due to osteochondrosis dissecans
- Smaller focally-limited, degenerative cartilage damage
- Patients aged between 18 and 55 years
- Cartilage defect sizes from 1.5 to 4 cm²
- Deep osseous substance defects require prior osseous reconstruction. The indication should be confirmed using arthroscopy.
Who cannot join
- Patients with known allergies to bovine collagen.
- Infected joints or infected wounds/areas near the joint, arthritis or inflammatory joint diseases of any type are contraindicated.
- More than two corresponding cartilage defects
- Instability of the knee, subtotal/total meniscus resection
- Varus/valgus malpositions (corrective surgery required in such cases)
- Haemorrhagic diathesis of various origins
- Applications which are not listed in the Indications section.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Switzerland2 sites
Cartilage Care
Bern, Cantone of Bern, 3012
Praxisklinik Rennbahn AG
Muttenz, Cantone of Basel-Landschaft, 4132
Germany1 site
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Mannheim, Baden-Wurttemberg, 68165
About this study
Official title: Non-interventional Study to Evaluate the Safety and Performance of NOVOCART® Basic and the Clinical Outcome of MAC With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee.
Retrospective, multicenter, single arm, non-interventional study to assess the safety and Performance of NOVOCART Basic and the clinical outcome of MAC with NOVOCART Basic in patients treated for cartilage defects in the knee.
Read the detailed description
This study is a multi-center, single arm, non-interventional study to assess the safety and performance of NOVOCART® Basic and the clinical outcome of MAC with NOVOCART® Basic in patients treated for cartilage defects in the knee. In this study data will be collected retrospectively from patient files of adult and pediatric patients who had received an MAC with NOVOCART® Basic for cartilage defects in the knee according to medical practice. In addition, at the time when a patient consents to participate in the study, he/she will have to fill-out questionnaires on current symptoms and knee function, quality of life, satisfaction with treatment and subsequent surgical interventions on the target knee performed outside the study site, i.e. the duration of follow-up is not standardized. All clinical sites having treated more than 8 patients with NOVOCART® Basic between 2014 and 2017 will be contacted for participation. Participating clinical sites will be asked to collect informed consent from their patients to document relevant data from their medical charts and to complete the questionnaires. Consenting patients will send the signed informed consent form(s) and the completed questionnaires back to the study site. The date of questionnaire completion is regarded the end of observation for an individual patient. For data documentation, a medical documentation specialist authorized by TETEC AG will be given access to the patient files, the informed consent forms, and the completed questionnaires. The relevant data will be entered directly into an electronic database by the medical documentation specialist. Only data from patients who have given informed consent to study participation will be documented. If available, post-MAC MRIs will be collected and reviewed by independent experts.
- Conditions
- Cartilage Diseases
- Being tested
- MAC with NOVOCART Basic
- Keywords
- cartilage defect, knee, MAC (Matrix associated chondrogenesis)
- Medical subject headings
- Cartilage Diseases, Mycobacterium avium-intracellulare Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAC with NOVOCART BasicDevice
Also called MAC
NOVOCART® Basic is a biphasic, collagen-based matrix to support the biological reconstruction of localized and full-thickness cartilage damages after treatment with bone marrow stimulation techniques (microfracture). The procedure is called matrix associated chondrogenesis (MAC). It is a single-step procedure.
NOVOCART® Basic is tailored to fit the prepared defect size and is inserted in the defect area after microfracture. The NOVOCART® Basic device component is fully resorbed over a period of a few months as new reparative cartilage tissue is generated and integrated with the surrounding host tissue.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety of NOVOCART® Basic
Number of participants with treatment related adverse device effects or adverse events related to the procedure involved
Measured: Up to 5 years
Secondary outcomes (9)
Rate of therapy change
Rate of therapy change (other surgical cartilage repair modality applied to the MAC treated defect(s))
Measured: Up to 5 years
Rate of adverse device effects
Number of treatment related adverse device effects
Measured: Up to 5 years
Rate of device deficiencies
Number of device deficiencies
Measured: Up to 5 years
Rate of adverse events related to the procedure involved
Number of adverse events related to the procedure involved
Measured: Up to 5 years
KOOS
Questionnaire: Knee injury and Osteoarthrisits Outcome Score (KOOS)(KOOS5 and subscores)
Measured: Up to 5 years
IKDC
Questionnaire: International Knee Documentation Committee (IKDC2000) subjective score
Measured: Up to 5 years
EQ-5D-5L
Quality of life (EQ-5D-5L index)
Measured: Up to 5 years
Patient satisfaction with treatment
5 questions to patient satisfaction with treatment
Measured: Up to 5 years
MRI if available
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score will be used for assessment of the in vivo performance, if post-MAC MRIs are available from clinical routine
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start9 Apr 2018
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DiseasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aesculap AG, Winicker Norimed GmbH
- Responsible party
- Sponsor
- Investigators
- Bernhard Waibl, MD, Principal investigator, Cartilage Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808623
- Sponsor's protocol ID
- AAG-O-H-1712
- Acronym
- NBasic
- Status last verified
- Mar 2020
- First submitted
- 8 Jan 2019
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Evaluate the Safety and Performance of NOVOCART® Basic and the Clinical Outcome of MAC With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee.
- ClinicalTrials.gov ID
- NCT03808623
- Acronym / sponsor ID
- NBasic / AAG-O-H-1712
- Conditions
- Cartilage Diseases
- Keywords
- cartilage defect, knee, MAC (Matrix associated chondrogenesis)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Tetec AGIndustry (pharma, biotech, devices)
- Collaborators
- Aesculap AG, Winicker Norimed GmbH
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 17 Jan 2019 (actual)
- 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.
Retrospective, multicenter, single arm, non-interventional study to assess the safety and Performance of NOVOCART Basic and the clinical outcome of MAC with NOVOCART Basic in patients treated for cartilage defects in the knee.
Detailed description
This study is a multi-center, single arm, non-interventional study to assess the safety and performance of NOVOCART® Basic and the clinical outcome of MAC with NOVOCART® Basic in patients treated for cartilage defects in the knee. In this study data will be collected retrospectively from patient files of adult and pediatric patients who had received an MAC with NOVOCART® Basic for cartilage defects in the knee according to medical practice. In addition, at the time when a patient consents to participate in the study, he/she will have to fill-out questionnaires on current symptoms and knee function, quality of life, satisfaction with treatment and subsequent surgical interventions on the target knee performed outside the study site, i.e. the duration of follow-up is not standardized. All clinical sites having treated more than 8 patients with NOVOCART® Basic between 2014 and 2017 will be contacted for participation. Participating clinical sites will be asked to collect informed consent from their patients to document relevant data from their medical charts and to complete the questionnaires. Consenting patients will send the signed informed consent form(s) and the completed questionnaires back to the study site. The date of questionnaire completion is regarded the end of observation for an individual patient. For data documentation, a medical documentation specialist authorized by TETEC AG will be given access to the patient files, the informed consent forms, and the completed questionnaires. The relevant data will be entered directly into an electronic database by the medical documentation specialist. Only data from patients who have given informed consent to study participation will be documented. If available, post-MAC MRIs will be collected and reviewed by independent experts.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- All patients (adult and pediatric) who have received an MAC with NOVOCART® Basic in the knee are eligible for this study, provided that they have given their informed consent for data collection and the involved clinical site has agreed to participate.
Key inclusion criteria (8 listed)
- for the biological reconstruction of localized full-layer cartilage damage (III and IV degree defects pursuant to the ICRS classification) in the knee joint.
- Treatable defects include:
- Cartilage damage caused by trauma
- Defects due to osteochondrosis dissecans
- Smaller focally-limited, degenerative cartilage damage
Key exclusion criteria (7 listed)
- Patients with known allergies to bovine collagen.
- Infected joints or infected wounds/areas near the joint, arthritis or inflammatory joint diseases of any type are contraindicated.
- More than two corresponding cartilage defects
- Instability of the knee, subtotal/total meniscus resection
- Varus/valgus malpositions (corrective surgery required in such cases)
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 |
|---|---|---|
| MAC with NOVOCART BasicAlso: MACNOVOCART® Basic is a biphasic, collagen-based matrix to support the biological reconstruction of localized and full-thickness cartilage damages after treatment with bone marrow stimulation techniques (microfracture). The procedure is called matrix associated chondrogenesis (MAC). It is a single-step procedure. NOVOCART® Basic is tailored to fit the prepared defect size and is inserted in the defect area after microfracture. The NOVOCART® Basic device component is fully resorbed over a period of a few months as new reparative cartilage tissue is generated and integrated with the surrounding host tissue. | Device | – |
Primary outcome
Assessment of the safety of NOVOCART® Basic
Time frame: Up to 5 years
Number of participants with treatment related adverse device effects or adverse events related to the procedure involved
9 secondary outcomes
Rate of therapy change
Time frame: Up to 5 years
Rate of adverse device effects
Time frame: Up to 5 years
Rate of device deficiencies
Time frame: Up to 5 years
Rate of adverse events related to the procedure involved
Time frame: Up to 5 years
KOOS
Time frame: Up to 5 years
IKDC
Time frame: Up to 5 years
EQ-5D-5L
Time frame: Up to 5 years
Patient satisfaction with treatment
Time frame: Up to 5 years
MRI if available
Time frame: Up to 5 years
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 2 Apr 2020.
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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.
Bernhard Waibl, MD principal investigator
Cartilage Care
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Diseases, run by Tetec AG at 3 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 8 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: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland, Germany. 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.
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?
Assessment of the safety of NOVOCART® Basic (time frame: Up to 5 years). 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 2 Apr 2020.