Osteochondral DefectNCT03385642
Follow-Up Study Evaluating the Long Term Outcome of ChondroMimetic in the Treatment of Osteochondral Defects in the Knee
An observational study of Osteochondral Defect, run by Collagen Solutions at 1 site in Hungary.
Trial summary
To investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in subjects who were treated in the interventional study 0MCM0107 for osteochondral defects of the knee. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteochondral Defect
- What is being tested?
- ChondroMimetic
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteHungary
- Study dates
- 29 May 2017to 22 Feb 2018
- 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: All subjects were treated with a Chondromimetic device under Protocol 0MCM0107
Treated with a Chondromimetic device under Protocol 0MCM0107 and completed the required follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-Up Study Evaluating the Long-Term Outcomes of ChondroMimetic in the Treatment of Osteochondral Defects (Extension Study of Protocol 0MCM0107)
To investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in subjects who were treated in the interventional study 0MCM0107 for osteochondral defects of the knee.
Read the detailed description
This is an open-label, single center, extension study to the previous interventional study 0MCM0107 designed to investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in the treatment of osteochondral defects of the knee. Follow-up to 6-months was completed as part of study 0MCM0107. All 17 subjects who received ChondroMimetic in study 0MCM0107 are eligible for enrolment into this extension study regardless of their current follow-up period.
- Conditions
- Osteochondral Defect
- Being tested
- ChondroMimetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChondroMimeticDevice
ChondroMimetic is a single-use, biphasic implant that serves as an osteochondral scaffold for the repair of cartilage defects in the knee
| Study group | Role | What they receive |
|---|---|---|
| Chondromimetic | Treatment of osteochondral defect in the knee with Chondromimetic device(s) in previous study 0MCM0107 Receives: Device: ChondroMimetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from 0MCM0107 baseline in Modified Cincinnati Rating System
Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery.
Measured: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
KOOS (Knee injury and Osteoarthritis Outcome Score
Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery.
Measured: Through study completion, an average of approximately 8 years follow-up
Cartilage repair tissue quantity and quality using 3D quantitative MRI analysis
Morphological segmentation utilizing a programmed anatomical atlas for all bone and cartilage structures will be used to assess defect filling (using previous MRI scans from study 0MCM0107 as reference), and T2 mapping for cartilage repair tissue quality.
Measured: Through study completion, an average of approximately 8 years follow-up
Osteochondral defect repair assessment
Defect repair outcomes will be assessed using the magnetic resonance observation of cartilage repair tissue (MOCART) subjective radiological scoring system.
Measured: Through study completion, an average of approximately 8 years follow-up
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Long-term safety will be assessed by physical and knee examination, and subject history since original treatment in study 0MCM0107
Measured: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start29 May 2017
- Primary completion22 Feb 2018
- Study completion22 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral DefectStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collagen Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laszlo Hangody, MD, PhD, DSc, Principal investigator, Uzsoki Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385642
- Sponsor's protocol ID
- 0MCM0107-2
- Status last verified
- Apr 2018
- First submitted
- 15 Dec 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-Up Study Evaluating the Long-Term Outcomes of ChondroMimetic in the Treatment of Osteochondral Defects (Extension Study of Protocol 0MCM0107)
- ClinicalTrials.gov ID
- NCT03385642
- Acronym / sponsor ID
- 0MCM0107-2
- Conditions
- Osteochondral Defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Collagen SolutionsIndustry (pharma, biotech, devices)
- Study start
- 29 May 2017 (actual)
- Primary completion
- 22 Feb 2018 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 28 Dec 2017 (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.
To investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in subjects who were treated in the interventional study 0MCM0107 for osteochondral defects of the knee.
Detailed description
This is an open-label, single center, extension study to the previous interventional study 0MCM0107 designed to investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in the treatment of osteochondral defects of the knee. Follow-up to 6-months was completed as part of study 0MCM0107. All 17 subjects who received ChondroMimetic in study 0MCM0107 are eligible for enrolment into this extension study regardless of their current follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chondromimetic | – | Device: ChondroMimeticTreatment of osteochondral defect in the knee with Chondromimetic device(s) in previous study 0MCM0107 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects were treated with a Chondromimetic device under Protocol 0MCM0107
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 |
|---|---|---|
| ChondroMimeticChondroMimetic is a single-use, biphasic implant that serves as an osteochondral scaffold for the repair of cartilage defects in the knee | Device | Chondromimetic |
Primary outcome
Change from 0MCM0107 baseline in Modified Cincinnati Rating System
Time frame: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery.
KOOS (Knee injury and Osteoarthritis Outcome Score
Time frame: Through study completion, an average of approximately 8 years follow-up
Subjective score designed to provide information regarding a patient's functional and clinical status after knee surgery.
Cartilage repair tissue quantity and quality using 3D quantitative MRI analysis
Time frame: Through study completion, an average of approximately 8 years follow-up
Morphological segmentation utilizing a programmed anatomical atlas for all bone and cartilage structures will be used to assess defect filling (using previous MRI scans from study 0MCM0107 as reference), and T2 mapping for cartilage repair tissue quality.
Osteochondral defect repair assessment
Time frame: Through study completion, an average of approximately 8 years follow-up
Defect repair outcomes will be assessed using the magnetic resonance observation of cartilage repair tissue (MOCART) subjective radiological scoring system.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
Long-term safety will be assessed by physical and knee examination, and subject history since original treatment in study 0MCM0107
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 17 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Osteochondral Defect
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
Enrolling by invitationPhase 3
A RCT of Collagen Scaffold for the Repair of Talus Cartilage Injury
Cartilage Defects, Talus Osteochondral Defect
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
RecruitingPhase 3
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Chondral Defect, Osteochondritis Dissecans (OCD)
Not yet recruiting
Biologic Augmentation of Osteochondral Allograft Transplantation in the Knee
Osteochondral Defect, Articular Cartilage Defect
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.
Laszlo Hangody, MD, PhD, DSc principal investigator
Uzsoki Hospital
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 Osteochondral Defect, run by Collagen Solutions at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. 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 Hungary. 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?
Change from 0MCM0107 baseline in Modified Cincinnati Rating System (time frame: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up). The study lists 5 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 17 Apr 2018.