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The clinical and radiology analysis of the time when to start rehabilitation after anterior cruciate ligament reconstrcution - A randomized controlled trial.

Status Approved

  • First Submitted Date

    2018/01/28

  • Registered Date

    2018/06/22

  • Last Updated Date

    2023/03/17

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
    KCT0002948
    Unique Protocol ID IIT-2016-232
    Public/Brief Title The clinical and radiology analysis of the time when to start rehabilitation after anterior cruciate ligament reconstrcution - A randomized controlled trial.
    Scientific Title The clinical and radiology analysis of the time when to start rehabilitation after anterior cruciate ligament reconstrcution - A randomized controlled trial.
    Acronym ETIRAR
    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 IIT-2016-232
    Approval Date 2017-07-19
    Institutional Review Board Name Inje University Seoul Paik Hospital Institutional Review Board
    Institutional Review Board Address 9, Mareunnae-ro, Jung-gu, Seoul
    Institutional Review Board Telephone 02-2270-0945
    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 Jung Gu Ha
    Title associate professor
    Telephone +82-2-2270-0285
    Affiliation Inje University
    Address 9, Mareunnae-ro, Jung-gu, Seoul, Republic of Korea
    Contact Person for Public Queries
    Name Yoonseok Kim
    Title Resident
    Telephone +82-2-2270-0285
    Affiliation Inje University Seoul Paik Hospital
    Address 9, Mareunnae-ro, Jung-gu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name Yoonseok Kim
    Title Resident
    Telephone +82-2-2270-0285
    Affiliation Inje University Seoul Paik Hospital
    Address 9, Mareunnae-ro, Jung-gu, Seoul, Republic of Korea
  • 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 Completed
    Date of First Enrollment 2017-07-20 Actual
    Target Number of Participant 38
    Primary Completion Date 2019-07-19 , Actual
    Study Completion Date 2019-07-19 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Inje University Seoul Paik Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-07-20 ,
  • 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 Inje University Seoul Paik Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Inje University Seoul Paik Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The anterior cruciate ligaments(ACL) are intra-articular, extra-synovial and multi-fascicular structures made up of 2 bundles that originate from the medial aspect of posterior intercondylar area of lateral femoral condyle and insert between the anterior horns of the medial and lateral menisci.
    They play significant roles in a stability of the knee joint, which are primary static structures resisting anterior translation of tibia on femur and secondary resistor on tibial rotation.
    In a real life, an average load on ACL while walking is about 400-500N and it increases up to 1700N with sudden acceleration or deceleration. 
    As a spare time activity is of great importance, there are increasing number of people playing sports, being injured through the activities or accidents.
    In United States, over 1000 thousands of people get a ACL reconstruction surgery annually.
    By far the most common mechanism of the ACL injury is abduction, flexion, and internal rotation of the femur on the tibia when the weight-bearing leg of a person is struck from the lateral aspect by an opponent. Sports where the ACL injury commonly occurs are soccer, basketball, skiing, etc.
    Acute phase treatment is focused on several aspects; minimizing hemarthrosis, recovering range of motion, the function of quadriceps muscle, proprioception and walking ability. In active patients non-surgical treatment can not get a satisfactory result.
    In a surgical treatment, a reconstruction of ACL is recommended as a standard therapy as other procedures including a repair or augmentation methods do not have surgical reproducibility and long-time stability.
    The strength of the graft is strongest right after the surgery and a necrosis progresses for 6 weeks at which the graft strength is weakest. A migration and proliferation of cells occur at 8 weeks to 10 weeks after the surgery and for several months they attach to bone slowly, forming a shape of the ACL ligament grossly. Therefore an early immoderate rehabilitation protocol may result in an unstable graft maturation and instability of the knee joint. In general, range of motion(ROM) exercise is recommended to be started after 1 week of a reconstruction surgery. However, recent several studies on animal testing show that a late ROM exercise aids graft healing. Furthermore, some reports insist that there is no difference on the outcome of the surgery in regard of the time to start ROM exercise. So, there is no consensus on the postoperative rehabilitation protocol especially on an accurate time for the initiation of ROM exercise.
    In this study, it is designed to compare the results of the treatment between early rehabilitation group in which patients get ROM exercise within 3 days after the ACL reconstruction surgery and delayed rehabilitation group in which patients get ROM exercise after 3 weeks of the surgery when some collagen fibers including indirect Sharpey’s fiber are formed on grafts.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Behavioral  
    Intervention Description
    The patients who underwent an anterior cruciate ligament reconstruction surgery were divided into two groups; early group that initiates a continuous passive range of motion exercise in 3 days after the surgery and delayed group that initiates the rehabilitation after 3 weeks of the surgery.
     Through the early exercise, the patients in the early group can return to everyday life and sports earlier than patients in the other group. However, a verification on functional and radiologic stability of the reconstructed anterior cruciate ligament is required through this study. Every variable other than the time when to start continuous range of motion exercise is identical to the other group.
    Number of Arms 2
    Arm 1

    Arm Label

    Delayed continuous passive of motion exercise group(Delayed group)

    Target Number of Participant

    19

    Arm Type

    Active comparator

    Arm Description

    A group undergoes delayed continuous passive range of motion exercise 3 weeks after the anterior cruciate ligament reconstruction surgery. Through the exercise, the patients in the group are expected to get more stability of the reconstructed anterior cruciate ligament. However, the three weeks of immobilization of the injured knee and a concomitant stiffness can delay the time to return to everyday life and sports. Every variable other than the time when to start continuous range of motion exercise is identical to the other group.
    Arm 2

    Arm Label

    Early continuous passive range of motion exercise group(Early group)

    Target Number of Participant

    19

    Arm Type

    Experimental

    Arm Description

    A group undergoes early continuous passive range of motion exercise in 3 days after the anterior cruciate ligament reconstruction surgery. Through the exercise, the patients in the group can return to everyday life and sports earlier than the other group. However, a verification on functional and radiologic stability of the reconstructed anterior cruciate ligament is required through this study. Every variable other than the time when to start continuous range of motion exercise is identical to the other group.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    (M00-M99)Diseases of the musculoskeletal system and connective tissue 

    Anterior Cruciate Ligament Anterior Cruciate Ligament Reconstruction Rehabilitation Range of Motion, Articular
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    Patient who gives written consent after full explanation of the study.
    Man or woman who is over 18 years old
    Patient who shows positive results on pivot shift test and anterior drawal test
    Patient who shows anterior cruciate ligament rupture on knee joint MRI
    Patient who has acute isolated ACL injury 
    Patient who shows knee joint range of motion as good as 90% of pre-injury range of motion
    Exclusion Criteria
    Patient who is under than 18 years old
    Patient who has additional injury other than anterior cruciate ligament injury such as posterior cruciate ligament, lateral collateral ligament, medial collateral ligament, etc.
    Patient who underwent meniscus repair surgery
    Patient who has past history of a fracture or a surgery on the injured knee joint
    Patient who is not proper for the study from a view of the lead researcher
    Patient who has an active infection on the injured knee joint
    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 /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Reconstructed tunnel sizes of the femur and tibia
    Timepoint
    Post operative day of 3 weeks, 6 weeks, 3 months, 6months, 12months, 24months
    Primary Outcome(s) 2
    Outcome
    Arthrometer exam(KT-2000)
    Timepoint
    Post operative day of 3 weeks, 6 weeks, 3 months, 6months, 12months, 24months
    Secondary Outcome(s) 1
    Outcome
    Degree of the reconstructed anterior cruciate ligament graft synovialization measured through knee MRI
    Timepoint
    Post operative day of 1 year
    Secondary Outcome(s) 2
    Outcome
    Range of motion,  Muscle strength, Muscle circumference
    Timepoint
    Post operative day of 3 weeks, 6 weeks, 3 months, 6months, 12months, 24months
    Secondary Outcome(s) 3
    Outcome
    Anterior draw test grade, Pivot shift test grade
    Timepoint
    Post operative day of 3 months, 6months, 12months, 24months
    Secondary Outcome(s) 4
    Outcome
    Visual analogue scales, International knee documentation committee score, Lysholm score , Tegner score
    Timepoint
    Post operative day of 3 weeks, 3 months, 6months, 12months, 24months
    Secondary Outcome(s) 5
    Outcome
    Single hop test, Vertical hop test, Y-balance test 
    Timepoint
    Post operative day of 3 months, 6months, 12months, 24months
  • 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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