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The effectiveness of multiple atelocollagen injection in partial thickness rotator cuff tear

Status Approved

  • First Submitted Date

    2020/02/21

  • Registered Date

    2020/02/25

  • Last Updated Date

    2024/01/22

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004766
    Unique Protocol ID KC20OISI0024
    Public/Brief Title The effectiveness of multiple atelocollagen injection in partial thickness rotator cuff tear
    Scientific Title The effectiveness of multiple atelocollagen injection in partial thickness rotator cuff tear
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KC20OISI0024
    Approval Date 2020-02-17
    Institutional Review Board Name The Catholic University of Korea, Seoul ST. Mary’s Hospital IRB
    Institutional Review Board Address 222, Banpo-daero, Seocho-gu, Seoul
    Institutional Review Board Telephone 02-2258-8202
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Yang Soo Kim
    Title professor
    Telephone +82-2-2258-2837
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address Seoul seochogu banpodaero 222
    Contact Person for Public Queries
    Name hyungseok Park
    Title clinical instructor
    Telephone +82-2-2258-6359
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address Seoul seochogu banpodaero 222
    Contact Person for Updating Information
    Name hyungseok Park
    Title clinical instructor
    Telephone +82-2-2258-6359
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address Seoul seochogu banpodaero 222
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Terminated
    Date of First Enrollment 2020-03-16 Actual
    Target Number of Participant 40
    Primary Completion Date 2021-12-31 , Actual
    Study Completion Date 2022-06-30 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Terminated Terminated Reason : 상기 연구는 더 이상의 enroll 가능한 환자가 없어 연구 종료하였습니다
    Date of First Enrollment 2020-03-16 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ubiosis
    Organization Type Others
    Project ID KC20OISI0024
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Korea, Seoul St. Mary's Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Partial thickness rotator cuff tears include articular side tear, bursal side tear, intratendinous tear, and complex type tear. The method of treatment for partial thickness rotator cuff tear may vary depending on the cause and location of the tear and the clinical symptoms of the patient. Initiate conservative treatments such as relaxation, lifestyle changes, and nonsteroidal anti-inflammatory drugs, which can be expected to reduce pain and reduce pain. Steroid injections can also be tried. Surgical treatment can be considered when clinical symptoms worsen or do not improve after adequate conservative treatment. Steroid injection therapy is widely used in injection therapy and its effect is known to be excellent. However, there have been reports of cases of collagen necrosis after steroid injection in the area of calcaneal tendon in rabbits, as well as reports on the association between steroid injection and rupture of the tendon. Recently, there has been research showing that steroids not only inhibit cell viability and collagen production, but also inhibit the proliferation of tenocytes. In comparison, atelocollagen injections have fewer reports of side effects. Tendons are composed of tenocytes, which are specialized mesenchyme-dervied cells in an extratracellualr matrix. The extracellular matrix is composed of more than 95% of type I collagen, and is composed of type III and V collagen, proteoglycan, elastin, and fibronectin. Collagen, the main component of the extracellular matrix, transmits power, dissipates energy, and supports soft tissues. Atelocollagen is made by removing the terminal telopeptide with a proteolytic enzyme, which lowers immunogenicity, and has many advantages that can lower side effects by improving biocompatibility and interaction between collagen and cells. If the healing reaction is difficult to activate due to lack of blood circulation such as cartilage, ligaments and tendons, it can be used as a method to increase the possibility of tissue healing. Currently, studies on the effect of collagen injection in the ankle and knee disease have been reported, but there is a lack of reports on collagen injection therapy in shoulder disease. Atelocollagen injection therapy has been performed to prevent the progression of rotator cuff tears. It will be confirmed and published in the journal. We will report on the effect of atelocollagen injections on rotator cuff tears. Atelocollagen injection therapy has been proven to be effective in reducing the tear size in patients with rotator cuff tears, and could be one of the treatment methods for partial rotator cuff tears. Currently, one to three injections of atelocollagen are tried depending on the size and recovery of rotator cuff tear. However, the relationship between the reduction of rotator cuff tear size and the recovery of shoulder function after atelocollagen injection therapy is insufficient. The purpose of this study is to analyze the degree of rotator cuff tear recovery after multiple atelocollagen injections in patients with partial thickness rotator cuff tears. In addition, we will analyze the relationship between the recovery of rotator cuff tear and the improvement of shoulder function by comparing the patients whose rotator cuff tear have recovered and those whose rotator cuff tear maintain or worsen.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Prospective  
    Target Number of Participant 40
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Group of patients with multiple atelocollagen injection in partial thickness rotator cuff tear

    Cohort/Group Description

    Study design: case series study
    The purpose of this study and the research method are explained in detail. A screening test will be conducted on those who have agreed in writing, and a person who meets the inclusion criteria will be selected. The study's plan will be detailed in the subject description and will be conducted only with patients who have received sufficient explanation and agreed. From the time of writing the research agreement, the patients will participate in the research. Patients who agreed to the study received two atelocollagen injections every three months. Atelocollagen injection treatment at 3 month intervals is an ongoing treatment protocol. During atelocollagen injection, the patient sterilizes the anterior and upper segments of the joint and humerus while keeping the arm in the crass position while sitting on a chair. During atelocollagen injection, the patient is sitting in a chair with patient's arm in the crass position, and the doctor sterilizes the anterior and upper part of the glenohumeral joint. Using a high-resolution transducer (12 MHz linear array), we would confirm that the needle is located at the rupture site of the rotator cuff and inject 1 ml of atelocollagen. The same method of atelocollagen injection is administered once more three months after the first atelocollagen injection. All patients who participated in the study would visit outpatient clinic at 6 weeks, 3months, 6months, and 12 months after injection. The doctor will check patient's range of motion, visual analog scale (VAS), the American Shoulder and Elbow Surgeons (ASES) score, Constant score, and Korean shoulder score at every visit of outpatient clinic. During the follow-up periods, pain control will be performed using NSAIDs. We would check the change of rotator cuff tear by ultrasound and magnetic resonance imaging. During the outpatient follow-up period, the patient is investigated for complications due to the ingjection or drug.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    1)	Adults over 30 and under 70
    2)	Partial thickness rotator cuff tear diagnosed by imaging test (ultrasound or MRI)
    Sampling Method
    Study design: case series study
    The purpose of this study and the research method are explained in detail. A screening test will be conducted on those who have agreed in writing, and a person who meets the inclusion criteria will be selected. The study's plan will be detailed in the subject description and will be conducted only with patients who have received sufficient explanation and agreed. From the time of writing the research agreement, the patients will participate in the research. Patients who agreed to the study received two atelocollagen injections every three months. Atelocollagen injection treatment at 3 month intervals is an ongoing treatment protocol. During atelocollagen injection, the patient sterilizes the anterior and upper segments of the joint and humerus while keeping the arm in the crass position while sitting on a chair. During atelocollagen injection, the patient is sitting in a chair with patient's arm in the crass position, and the doctor sterilizes the anterior and upper part of the glenohumeral joint. Using a high-resolution transducer (12 MHz linear array), we would confirm that the needle is located at the rupture site of the rotator cuff and inject 1 ml of atelocollagen. The same method of atelocollagen injection is administered once more three months after the first atelocollagen injection. All patients who participated in the study would visit outpatient clinic at 6 weeks, 3months, 6months, and 12 months after injection. The doctor will check patient's range of motion, visual analog scale (VAS), the American Shoulder and Elbow Surgeons (ASES) score, Constant score, and Korean shoulder score at every visit of outpatient clinic. During the follow-up periods, pain control will be performed using NSAIDs. We would check the change of rotator cuff tear by ultrasound and magnetic resonance imaging. During the outpatient follow-up period, the patient is investigated for complications due to the ingjection or drug.
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M75.1)Rotator cuff syndrome 

    Rotator Cuff Injuries, partial thickness Rotator Cuff Tear
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    30Year~69Year

    Description

    Inclusion Criteria
    1)	Adults over 30 and under 70
    2)	Partial thickness rotator cuff tear diagnosed by imaging test (ultrasound or MRI)
    3)	Patients who have been treated for more than 3 months by medication or physical therapy but have not improved
    4)	If the concomitant medication continues to be administered during the trial, patients who have confirmed the correct prescription drug being taken within at least one week and agreed to maintain a constant amount as before injection during the study
    5)	patients who understand the study, agree to participate in the study, and have their own written consent
    Exclusion Criteria
    Exclusion Criteria 
    1)	Patients with previous history of injection therapy within 6 weeks
    2)	Patients with Adhesive capsulitis
    3)	Full thickness rotator cuff tears diagnosed by MRI or ultrasound
    4)	Patients with a history of uncontrolled diabetes, infectious arthritis, rheumatoid arthritis, tumors, fractures, degenerative arthritis
    5)	Patients who refuse injection
    6)	Patients who want surgical treatment
    7)	Patients with hypersensitivity to collagen
    8)	Pregnant or lactating or planning to become pregnant
    9)	Patients expected to have complications because of anticoagulants therapy
    10)	Patients sensitive to pig protein
    11)	Patients with a history of radiotherapy and chemotherapy within the past 2 years (except when it is determined that collagen can be administered as judged by a clinician)
    12)	Patients or family members with autoimmune disease in progress or with past military service
    13)	Patients who are sensitive to implants 
    14)	Any clinically significant health abnormalities that can affect the completion of the study
    15)	Patients deemed inappropriate for this study by the judgment of doctor such as mental illness
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    imaging study : shoulder MRI
    Timepoint
    6 months after first injection
    Secondary Outcome(s) 1
    Outcome
    shoulder sonography
    Timepoint
    6 weeks, 3 months, 12 months after first injection
    Secondary Outcome(s) 2
    Outcome
    shoulder functional score (ASES score, Constant score, KSES score)
    Timepoint
    6 weeks, 3 months, 6months, 12 months after first injection
    Secondary Outcome(s) 3
    Outcome
    shoulder range of motion
    Timepoint
    6 weeks, 3 months, 6months, 12 months after first injection
    Secondary Outcome(s) 4
    Outcome
    Pain VAS score
    Timepoint
    6 weeks, 3 months, 6months, 12 months after first injection
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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