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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
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Collagen Augmentation

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 11, 2016
    Last Updated
    February 14, 2016
    Sponsor
    The Catholic University of Korea
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    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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