Collagen AugmentationNCT02685917
Microfracture With/Without Collagen Augmentation in Patients Undergoing High Tibial Osteotomy
A study testing Microfracture without Collagen Augmentation and Microfracture with Collagen Augmentation in people with Collagen Augmentation, run by The Catholic University of Korea.
Trial summary
The quality of cartilage regeneration after marrow stimulation is well documented to be unpredictable, because they do not regenerate consistent amount of cartilage. To overcome the shortcomings of the microfracture technique, various augmentation techniques using synthetic collagen matrix, scaffolds or plug devices… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Collagen Augmentation
- What is being tested?
- Microfracture without Collagen Augmentation and Microfracture with Collagen Augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2017
- Phase
- Interventional
- 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
Who may be able to join
- Aged below 65 years with isolated medial compartment osteoarthritis
- Good range of motion
- No ligament instability
- Having medicare insurance
Who cannot join
- Diagnosis of severe tricompartment osteoarthritis indicated for total knee arthroplasty
- Inflammatory arthritis(rheumatoid arthritis), osteonecrosis
- Flexion contracture ≥ 15°
- Knee range of motion < 120°
- Joint instability
- A history of knee joint infection and who refused to participate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Microfracture With/Without Collagen Augmentation in Patients Undergoing High Tibial Osteotomy: A Randomized, Controlled, Double-Blind Trial
The quality of cartilage regeneration after marrow stimulation is well documented to be unpredictable, because they do not regenerate consistent amount of cartilage. To overcome the shortcomings of the microfracture technique, various augmentation techniques using synthetic collagen matrix, scaffolds or plug devices have been developed. However, their efficacy remains unclear. The purpose of this prospective randomized controlled study is to evaluate whether the microfracture in combination with collagen gel augmentation could improve the quality of cartilage regeneration in patients undergoing medial open wedge high tibial osteotomy (HTO) for the treatment of medial unicompartmental knee osteoarthritis (OA).
Read the detailed description
CartiFill™ (atelocollagen, Sewon Cellontech, Seoul, Korea) was developed to to provide a matrix stability and to maintain the blood clot in the defect site, which promoted the cartilage regeneration by mesenchymal stem cell . It was a atelocollagen, highly purified porcine derived type collagen І that has been modified to virtually eliminate the risk of rejection by removal of telopeptide.
The investigators randomized patients undergoing HTO in combination with microfracture to receive either microfracture alone (control group, n = 5) or microfracture with collagen augmentation (experimental group, n=6). At postoperative one year, the clinical outcome in terms of Visual Analogue Scale of pain level (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, and Tegner scores were evaluated. In addition, second look arthroscopic examination and biopsy of regenerated cartilage were carried out when the HTO plate was removed at postoperative one year. Biopsy specimens were graded by International Cartilage Repair Society Visual Assessment Scale (ICRS II scores). Finally, radiologic outcome in terms of Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores was assessed using follow up MRI undertaken at postoperative one year.
- Conditions
- Collagen Augmentation
- Being tested
- Microfracture without Collagen Augmentation, Microfracture with Collagen Augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfracture without Collagen AugmentationProcedure or surgery
Cartifill applied for collagen augmentation
Microfracture with Collagen AugmentationProcedure or surgery
Cartifill applied for collagen augmentation
| Study group | Role | What they receive |
|---|---|---|
| Microfracture with Collagen Augmentation in HTO | Experimental | Two groups, either collagen augmentation or not. Firstly, all patients underwent an arthroscopic examination and microfracture for bone marrow. Collagen augmentation included Cartifill insertion after arthroscopic microfracture. Receives: Procedure: Microfracture with Collagen Augmentation |
| Microfracture without Collagen Augmentation in HTO | Active comparator | Two groups, either collagen augmentation or not. Firstly, all patients underwent an arthroscopic examination and microfracture for bone marrow. Collagen augmentation included Cartifill insertion after arthroscopic microfracture. Receives: Procedure: Microfracture without Collagen Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: Change from Baseline score to score of postoperative 1 year.
International Knee Documentation Committee (IKDC) score
Measured: Change from Baseline score to score of postoperative 1 year.
Tegner score
Measured: Change from Baseline score to score of postoperative 1 year.
Secondary outcomes (2)
The MRI observation of cartilage repair tissue (MOCART) score
Measured: Preoperative & postoperative 1 year.
International Cartilage Repair Society (ICRS) II scoring system
Measured: Postoperative 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagen AugmentationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
- Investigators
- Yong In, MD, PhD, Study chair, the Catholic Univerisity of Korea Seoul St Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685917
- Sponsor's protocol ID
- Collagen augmentation
- Status last verified
- Feb 2016
- First submitted
- 11 Feb 2016
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Microfracture With/Without Collagen Augmentation in Patients Undergoing High Tibial Osteotomy: A Randomized, Controlled, Double-Blind Trial
- ClinicalTrials.gov ID
- NCT02685917
- Acronym / sponsor ID
- Collagen augmentation
- Conditions
- Collagen Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 19 Feb 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.
The quality of cartilage regeneration after marrow stimulation is well documented to be unpredictable, because they do not regenerate consistent amount of cartilage. To overcome the shortcomings of the microfracture technique, various augmentation techniques using synthetic collagen matrix, scaffolds or plug devices have been developed. However, their efficacy remains unclear. The purpose of this prospective randomized controlled study is to evaluate whether the microfracture in combination with collagen gel augmentation could improve the quality of cartilage regeneration in patients undergoing medial open wedge high tibial osteotomy (HTO) for the treatment of medial unicompartmental knee osteoarthritis (OA).
Detailed description
CartiFill™ (atelocollagen, Sewon Cellontech, Seoul, Korea) was developed to to provide a matrix stability and to maintain the blood clot in the defect site, which promoted the cartilage regeneration by mesenchymal stem cell . It was a atelocollagen, highly purified porcine derived type collagen І that has been modified to virtually eliminate the risk of rejection by removal of telopeptide.
The investigators randomized patients undergoing HTO in combination with microfracture to receive either microfracture alone (control group, n = 5) or microfracture with collagen augmentation (experimental group, n=6). At postoperative one year, the clinical outcome in terms of Visual Analogue Scale of pain level (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, and Tegner scores were evaluated. In addition, second look arthroscopic examination and biopsy of regenerated cartilage were carried out when the HTO plate was removed at postoperative one year. Biopsy specimens were graded by International Cartilage Repair Society Visual Assessment Scale (ICRS II scores). Finally, radiologic outcome in terms of Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores was assessed using follow up MRI undertaken at postoperative one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microfracture with Collagen Augmentation in HTO | Experimental | Procedure: Microfracture with Collagen AugmentationTwo groups, either collagen augmentation or not. Firstly, all patients underwent an arthroscopic examination and microfracture for bone marrow. Collagen augmentation included Cartifill insertion after arthroscopic microfracture. |
| Microfracture without Collagen Augmentation in HTO | Active comparator | Procedure: Microfracture without Collagen AugmentationTwo groups, either collagen augmentation or not. Firstly, all patients underwent an arthroscopic examination and microfracture for bone marrow. Collagen augmentation included Cartifill insertion after arthroscopic microfracture. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged below 65 years with isolated medial compartment osteoarthritis
- Good range of motion
- No ligament instability
- Having medicare insurance
Key exclusion criteria (6 listed)
- Diagnosis of severe tricompartment osteoarthritis indicated for total knee arthroplasty
- Inflammatory arthritis(rheumatoid arthritis), osteonecrosis
- Flexion contracture ≥ 15°
- Knee range of motion < 120°
- Joint instability
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 |
|---|---|---|
| Microfracture without Collagen AugmentationCartifill applied for collagen augmentation | Procedure or surgery | Microfracture without Collagen Augmentation in HTO |
| Microfracture with Collagen AugmentationCartifill applied for collagen augmentation | Procedure or surgery | Microfracture with Collagen Augmentation in HTO |
Primary outcome
knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Change from Baseline score to score of postoperative 1 year.
International Knee Documentation Committee (IKDC) score
Time frame: Change from Baseline score to score of postoperative 1 year.
Tegner score
Time frame: Change from Baseline score to score of postoperative 1 year.
2 secondary outcomes
The MRI observation of cartilage repair tissue (MOCART) score
Time frame: Preoperative & postoperative 1 year.
International Cartilage Repair Society (ICRS) II scoring system
Time frame: Postoperative 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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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.
Yong In, MD, PhD study chair
the Catholic Univerisity of Korea Seoul St Mary's hospital
Questions about this trial
What is this clinical trial studying?
A study testing Microfracture without Collagen Augmentation and Microfracture with Collagen Augmentation in people with Collagen Augmentation, run by The Catholic University of 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong In, MD, PhD (8290445228, iy1000@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Change from Baseline score to score of postoperative 1 year.). 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 19 Feb 2016.