Osteoarthritis, KneeNCT06278480
Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application
An observational study of Osteoarthritis, Knee, run by L&C Bio at 1 site in South Korea.
Trial summary
The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- MegaCarti® and microfracture
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2023to 29 Mar 2024
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent HTO were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.
Who may be able to join
- Patients participating in the "Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® ; Cartilage Defect Treatment Assisting Cartilage Regeneration in Knee Cartilage Defects : Multicenter, Independent Evaluator and Subject Blinded, Microfracture Comparative, Superiority, Randomized, Confirmatory Clinical Study and 5 Years Follow up Study"
- Patients who simultaneously underwent HTO during knee joint cartilage surgery
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Gangnam Severance Hospital
Seoul, Seoul, 06273
About this study
Official title: Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application : Multicenter, Comparative, Evaluator-blinded, Retrospective Study
The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.
- Conditions
- Osteoarthritis, Knee
- Being tested
- MegaCarti®, microfracture
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MegaCarti®Device
Medical devices containing allogeneic cartilage
microfractureProcedure or surgery
microfracture
| Study group | Role | What they receive |
|---|---|---|
| MegaCarti® | Experimental: MegaCarti® application after microfracture The experimental group is applied with MegaCarti® and underwent high tibial osteotomy(HTO) after microfracture. Receives: Device: MegaCarti®; Procedure: microfracture | |
| Microfracture only | The control group underwent microfracture and high tibial osteotomy(HTO) Receives: Procedure: microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment
Primary Endpoint [experimental group / control group]
Measured: When removing fixtures after HTO (an average of 1 year after surgery)
Comparison of macroscopic status of regenerated cartilage
Primary Endpoint [experimental group / control group]
Measured: When removing fixtures after HTO (an average of 1 year after surgery)
Secondary outcomes (6)
Comparison of IKDC score
Secondary Endpoint [experimental group / control group], Higher scores mean a better outcome
Measured: At last visit (an average of two years after surgery)
Comparison of VAS score
Secondary Endpoint [experimental group / control group], Higher scores mean a worse outcome
Measured: At last visit (an average of two years after surgery)
Comparison of KOOS score
Secondary Endpoint [experimental group / control group], Higher scores mean a better outcome
Measured: At last visit (an average of two years after surgery)
Comparison of WOMAC score
Secondary Endpoint [experimental group / control group], Higher scores mean a worse outcome
Measured: At last visit (an average of two years after surgery)
Comparison of Kellgren-Lawrence grade
Secondary Endpoint [experimental group / control group]
Measured: At last visit (an average of two years after surgery)
Comparison of HKA angle, Posterior Tibial slope
Secondary Endpoint [experimental group / control group]
Measured: At last visit (an average of two years after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start23 Jun 2023
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- L&C Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278480
- Sponsor's protocol ID
- LNC-MECA-003
- Status last verified
- Oct 2024
- First submitted
- 25 Jan 2024
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application : Multicenter, Comparative, Evaluator-blinded, Retrospective Study
- ClinicalTrials.gov ID
- NCT06278480
- Acronym / sponsor ID
- LNC-MECA-003
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- L&C BioIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 26 Feb 2024 (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.
The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MegaCarti® | – | Device: MegaCarti®, Procedure: microfractureExperimental: MegaCarti® application after microfracture The experimental group is applied with MegaCarti® and underwent high tibial osteotomy(HTO) after microfracture. |
| Microfracture only | – | Procedure: microfractureThe control group underwent microfracture and high tibial osteotomy(HTO) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent HTO were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.
Key inclusion criteria (2 listed)
- Patients participating in the "Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® ; Cartilage Defect Treatment Assisting Cartilage Regeneration in Knee Cartilage Defects : Multicenter, Independent Evaluator and Subject Blinded, Microfracture Comparative, Superiority, Randomized, Confirmatory Clinical Study and 5 Years Follow up Study"
- Patients who simultaneously underwent HTO during knee joint cartilage surgery
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| MegaCarti®Medical devices containing allogeneic cartilage | Device | MegaCarti® |
| microfracturemicrofracture | Procedure or surgery | MegaCarti®, Microfracture only |
Primary outcome
Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment
Time frame: When removing fixtures after HTO (an average of 1 year after surgery)
Primary Endpoint [experimental group / control group]
Comparison of macroscopic status of regenerated cartilage
Time frame: When removing fixtures after HTO (an average of 1 year after surgery)
Primary Endpoint [experimental group / control group]
6 secondary outcomes
Comparison of IKDC score
Time frame: At last visit (an average of two years after surgery)
Comparison of VAS score
Time frame: At last visit (an average of two years after surgery)
Comparison of KOOS score
Time frame: At last visit (an average of two years after surgery)
Comparison of WOMAC score
Time frame: At last visit (an average of two years after surgery)
Comparison of Kellgren-Lawrence grade
Time frame: At last visit (an average of two years after surgery)
Comparison of HKA angle, Posterior Tibial slope
Time frame: At last visit (an average of two years after surgery)
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 9 Oct 2024.
- Individual participant dataSharing planned: No
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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.
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 Osteoarthritis, Knee, run by L&C Bio at 1 site in South Korea.
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 2 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 9 Oct 2024. 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 South Korea. 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?
Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment (time frame: When removing fixtures after HTO (an average of 1 year after surgery)). The study lists 2 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 9 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.