Cartilage DiseaseRENOVONCT02941120
Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects
An observational study of Cartilage Disease, run by Tetec AG at 7 sites in Germany.
Trial summary
Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Cartilage Disease
- How many people
- 245 participants
- Where
- 7 sitesGermany
- Study dates
- Dec 2015to May 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 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Orthopaedic clinics
Who may be able to join
- male and female patients
- juvenile patients with closed epiphysial plate
- insulated full-thickness cartilage damage of the knee Joint, ICRS (International Cartilage Repair Society) grade 3-4
- defect size ≥ 2.5 and ≤ 10 cm2
- intact or reconstructed bony subchondral plate
- in the case of deep bony substance defects, additional bony reconstruction is needed
Who cannot join
- radiographic signs of osteoarthritis of Kellgren and Lawrence > 2
- joint stiffness
- arthrofibrosis
- malalignment in the knee (valgus- or varus deformity) > 3° (correction contemporary to the ACT)
- insufficient reconstructed ligaments (correction contemporary to the ACT)
- defective position patella (correction contemporary to the ACT)
Show all 13Show fewer
- sled prosthesis implants or carbon pin
- inflammatory joint diseases (f.e. rheumatoid arthritis)
- corresponding cartilage defects ("kissing lesions")
- more than two independent cartilage defects in one knee
- primary cartilage reconstructive treatment in children and juvenile with open epiphysial plate
- diffuse chondromalacia
- congenital or gained deformity of patella
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Hochtaunus-Kliniken gGmbH Krankenhaus Bad Homburg
Bad Homburg, 61348
Gelenk-Klinik Gundelfingen
Gundelfingen, 79194
Orthopädische Praxisklinik im Zentrum
Kelkheim, 65779
Orthopädische Klinik Markgröningen gGmbH
Markgröningen, 71706
Dr. med. Michael Moraldo, Dr. med. Sebastian Lauber
Münster, 48165
Nordwest-Krankenhaus Sanderbusch gGmbH
Sande, 26452
Muldentalkliniken GmbH Krankenhaus Wurzen
Wurzen, 04808
About this study
Official title: Retrospective Observational Study for Reconstruction of Localized, Full-thickness Cartilage Defects in the Knee Joint With In-situ Polymerizable and Chondrocyte Populated Biomaterial (NOVOCART® Inject)
Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.
Read the detailed description
Retrospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with localized full-thickness cartilage defects in the knee joint.
Safety: Measuring the number of adverse drug reactions/serious adverse drug reactions since treatment and up to the present time.
Efficacy: Evaluate symptoms and functional status at the present time using IKDC 2000 (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome score).
- Conditions
- Cartilage Disease
- Keywords
- Cartilage defect, Knee, ACT (Autologous chondrocyte implantation), NOVOCART® Inject
- Medical subject headings
- Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NOVOCART® Inject patients | Patients who where treated with NOVOCART® Inject autologous chondrocyte implantation in the knee joint. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse drug reaction/serious adverse drug reaction
Number of adverse drug reaction/serious adverse drug reaction as a measurement of safety
Measured: Up to 24 months
Secondary outcomes (2)
Outcome of IKDC 2000
Outcome of the IKDC 2000 as measurements of symptoms and function
Measured: Up to 24 months
Outcome of KOOS
Outcome of KOOS as measurements of symptoms and function
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startDec 2015
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DiseaseStudies 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
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aesculap AG, Winicker Norimed GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941120
- Sponsor's protocol ID
- AAG-O-H-1521
- Acronym
- RENOVO
- Status last verified
- Jan 2019
- First submitted
- 18 Oct 2016
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study for Reconstruction of Localized, Full-thickness Cartilage Defects in the Knee Joint With In-situ Polymerizable and Chondrocyte Populated Biomaterial (NOVOCART® Inject)
- ClinicalTrials.gov ID
- NCT02941120
- Acronym / sponsor ID
- RENOVO / AAG-O-H-1521
- Conditions
- Cartilage Disease
- Keywords
- Cartilage defect, Knee, ACT (Autologous chondrocyte implantation), NOVOCART® Inject
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Tetec AGIndustry (pharma, biotech, devices)
- Collaborators
- Aesculap AG, Winicker Norimed GmbH
- Study start
- Dec 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 21 Oct 2016 (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.
Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.
Detailed description
Retrospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with localized full-thickness cartilage defects in the knee joint.
Safety: Measuring the number of adverse drug reactions/serious adverse drug reactions since treatment and up to the present time.
Efficacy: Evaluate symptoms and functional status at the present time using IKDC 2000 (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome score).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOVOCART® Inject patients | – | –Patients who where treated with NOVOCART® Inject autologous chondrocyte implantation in the knee joint. |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Orthopaedic clinics
Key inclusion criteria (6 listed)
- male and female patients
- juvenile patients with closed epiphysial plate
- insulated full-thickness cartilage damage of the knee Joint, ICRS (International Cartilage Repair Society) grade 3-4
- defect size ≥ 2.5 and ≤ 10 cm2
- intact or reconstructed bony subchondral plate
Key exclusion criteria (13 listed)
- radiographic signs of osteoarthritis of Kellgren and Lawrence > 2
- joint stiffness
- arthrofibrosis
- malalignment in the knee (valgus- or varus deformity) > 3° (correction contemporary to the ACT)
- insufficient reconstructed ligaments (correction contemporary to the ACT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of adverse drug reaction/serious adverse drug reaction
Time frame: Up to 24 months
Number of adverse drug reaction/serious adverse drug reaction as a measurement of safety
2 secondary outcomes
Outcome of IKDC 2000
Time frame: Up to 24 months
Outcome of KOOS
Time frame: Up to 24 months
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 3 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Disease, run by Tetec AG at 7 sites in Germany.
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 6 inclusion and 13 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 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in 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?
Number of adverse drug reaction/serious adverse drug reaction (time frame: Up to 24 months). 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 3 Dec 2019.