Microfracture With/Without Collagen Augmentation in Patients Undergoing High Tibial Osteotomy
Primary Purpose
Collagen Augmentation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microfracture without Collagen Augmentation
Microfracture with Collagen Augmentation
Sponsored by
About this trial
This is an interventional treatment trial for Collagen Augmentation
Eligibility Criteria
Inclusion Criteria:
- Aged below 65 years with isolated medial compartment osteoarthritis
- Good range of motion
- No ligament instability
- Having medicare insurance
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Microfracture with Collagen Augmentation in HTO
Microfracture without Collagen Augmentation in HTO
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
knee Injury and Osteoarthritis Outcome Score (KOOS)
International Knee Documentation Committee (IKDC) score
Tegner score
Secondary Outcome Measures
The MRI observation of cartilage repair tissue (MOCART) score
International Cartilage Repair Society (ICRS) II scoring system
Full Information
NCT ID
NCT02685917
First Posted
February 11, 2016
Last Updated
February 14, 2016
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT02685917
Brief Title
Microfracture With/Without Collagen Augmentation in Patients Undergoing High Tibial Osteotomy
Official Title
Effects of Microfracture With/Without Collagen Augmentation in Patients Undergoing High Tibial Osteotomy: A Randomized, Controlled, Double-Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Collagen Augmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microfracture with Collagen Augmentation in HTO
Arm Type
Experimental
Arm Description
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.
Arm Title
Microfracture without Collagen Augmentation in HTO
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Microfracture without Collagen Augmentation
Intervention Description
Cartifill applied for collagen augmentation
Intervention Type
Procedure
Intervention Name(s)
Microfracture with Collagen Augmentation
Intervention Description
Cartifill applied for collagen augmentation
Primary Outcome Measure Information:
Title
knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
Change from Baseline score to score of postoperative 1 year.
Title
International Knee Documentation Committee (IKDC) score
Time Frame
Change from Baseline score to score of postoperative 1 year.
Title
Tegner score
Time Frame
Change from Baseline score to score of postoperative 1 year.
Secondary Outcome Measure Information:
Title
The MRI observation of cartilage repair tissue (MOCART) score
Time Frame
Preoperative & postoperative 1 year.
Title
International Cartilage Repair Society (ICRS) II scoring system
Time Frame
Postoperative 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged below 65 years with isolated medial compartment osteoarthritis
Good range of motion
No ligament instability
Having medicare insurance
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong In, MD, PhD
Phone
8290445228
Email
iy1000@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Mansoo Kim, MD
Phone
8272333875
Email
kms3779@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong In, MD, PhD
Organizational Affiliation
the Catholic Univerisity of Korea Seoul St Mary's hospital
Official's Role
Study Chair
12. IPD Sharing Statement
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Microfracture With/Without Collagen Augmentation in Patients Undergoing High Tibial Osteotomy
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