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
CRIS Registration Number |
KCT0002948 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Inje University Seoul Paik Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Inje University Seoul Paik Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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 |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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 |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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