Articular CartilageNCT00140634
The Objectives of the Cartilage Repair Registry is to Report Long Term Efficacy and Safety of Cartilage Repair Procedures in Registry Patients
An observational study of Articular Cartilage and Cartilage Diseases, run by Vericel Corporation at 1 site in United States.
Trial summary
The objectives of the Cartilage Repair Registry is to report the long term efficacy and safety of cartilage repair procedures in Registry patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Articular Cartilage, Cartilage Diseases
- What is being tested?
- Carticel (autologous cultured chondrocyte) implantation
- How many people
- 2,233 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1995to Jan 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Registry of patients with diagnosis of chondral injury.
Who may be able to join
- All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort
Who cannot join
- All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort
Trial locations and contacts
1 site in 1 country.
United States1 site
Registry contains data from patients whom were implanted by 1123 surgeons in the U.S. and also data captured on patients treated by 154 surgeons in 15 other countries.
Cambridge, Massachusetts, 02142
About this study
Official title: Cartilage Repair Registry
The objectives of the Cartilage Repair Registry is to report the long term efficacy and safety of cartilage repair procedures in Registry patients.
- Conditions
- Articular Cartilage, Cartilage Diseases
- Being tested
- Carticel (autologous cultured chondrocyte) implantation
- Medical subject headings
- Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carticel (autologous cultured chondrocyte) implantationBiological
Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap.
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician assessment of effectiveness of autologous chondrocyte implantation
Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation
Measured: 6 month post implantation
Physician assessment of effectiveness of autologous chondrocyte implantation
Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation
Measured: 12 month post implantation
Physician assessment of effectiveness of autologous chondrocyte implantation
Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation
Measured: 24 month post implantation
Secondary outcomes (1)
Patient assessment of effectiveness of autologous chondrocyte implantation
Overall assessment of the patient by the patient based on pain, swelling, giving-way, grinding, stiffness, catching and locking and quantity of exercise
Measured: 6 month post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startMar 1995
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular CartilageStudies 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
- Other
- Enrolment
- 2,233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vericel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140634
- Sponsor's protocol ID
- Cartilage Repair Registry
- Status last verified
- May 2021
- First submitted
- 31 Aug 2005
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartilage Repair Registry
- ClinicalTrials.gov ID
- NCT00140634
- Acronym / sponsor ID
- Cartilage Repair Registry
- Conditions
- Articular Cartilage, Cartilage Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,233 participants (actual)
- Lead sponsor
- Vericel CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 1995
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Sep 2005 (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.
The objectives of the Cartilage Repair Registry is to report the long term efficacy and safety of cartilage repair procedures in Registry patients.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Registry of patients with diagnosis of chondral injury.
Key inclusion criteria (1 listed)
- All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort
Key exclusion criteria (1 listed)
- All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort
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 |
|---|---|---|
| Carticel (autologous cultured chondrocyte) implantationEach Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap. | Biological | – |
Primary outcome
Physician assessment of effectiveness of autologous chondrocyte implantation
Time frame: 6 month post implantation
Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation
Physician assessment of effectiveness of autologous chondrocyte implantation
Time frame: 12 month post implantation
Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation
Physician assessment of effectiveness of autologous chondrocyte implantation
Time frame: 24 month post implantation
Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation
1 secondary outcome
Patient assessment of effectiveness of autologous chondrocyte implantation
Time frame: 6 month post implantation
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 11 May 2021.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Articular Cartilage and Cartilage Diseases, run by Vericel Corporation at 1 site in United States.
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 1 inclusion and 1 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Physician assessment of effectiveness of autologous chondrocyte implantation (time frame: 6 month post implantation). The study lists 3 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 11 May 2021.