Single and Double Bundle ACL Reconstructions, in Term of Cartilage Damage Due to Remaining Instability After Surgery.
NCT ID: NCT04626999
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
52 participants
INTERVENTIONAL
2018-01-08
2021-06-30
Brief Summary
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This study requires around 47-52 subjects divided into two operation techniques of SBACLR and DBACLR. To evaluate the results from COMP, MRI T2 mapping, Lachman test, pivot shift test, and Rolimeter, this study is divided into three timeframes: before an operation, three months after post-operation, and six months post-operations. The differences between the test variables are then used as an indicator to assess the cartilage conditions from two operation techniques: SBACLR and DBACLR. Subsequently, the study also examines the possible correlation of each of the resulting variables.
Detailed Description
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This study's estimated time is between two to three years ranging from January 2018 until the end of June 2021.
The samples are randomly divided into two groups: the SBACLR group and the DBACLR group. The sample size for each group was 26 subjects. For the subjects, the accepted inclusion criteria were male, age 18-40 years, total primary AC rupture, injury time 1-12 months, willingness to attend the study, and signed informed consent.
Exclusion criteria include subjects having other ligament injuries in the knee, history of rheumatoid arthritis, severe osteoarthritis Kellgren-Lawrence grading\> 2, Body Mass Index (BMI) ≥ 25, fracture around the knee joint or osteochondral avulsion, history of injury with either or both semitendinosus or gracilis muscle, patellofemoral instability, contraindication of anesthesia, and partial ACL rupture.
Drop Out criteria includes: subjects not returning to control, undergoing treatment outside the program, not complying with study protocols, re-injury to the studied knee causing ligament, meniscus or cartilage injury, and postoperative knee infection.
Prospective subjects have been diagnosed with the total loss of ACL and meet the research criteria are explained about the aims and objectives of the study and sign a consent form to participate in the study.
Each subject was assigned to one of the study groups through a simple randomization method: the SBACL reconstruction surgery action group or the DBACL reconstruction surgery action group.
All subjects were examined the Lachman test, pivot test, Rolimeter measurement, MRI T2 mapping, and knee joint fluid for ELISA examination of sfCOMP (synovial fluid COMP) at the time before surgery, the third month, and the sixth month postoperatively.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Synovial fluid COMP
Knee joint fluid is aspirated for ELISA COMP examination
Single Bundle ACL Reconstruction
Arthroscopy Single Bundle ACL Reconstruction is a procedure to reconstruct the ACL using one bundle.
The procedure uses Hamstring (Gracillis muscle and Semitendinosus muscle) as a graft.
Double Bundle ACL Reconstruction
Arthroscopy Double Bundle ACL Reconstruction is a procedure to reconstruct the ACL using Two bundles (Double bundle).
The procedure uses Gracillis tendon as a Posterolateral bundle graft and Semitendinosus tendon as an Anteromedial bundle graft.
MRI T2 Mapping
Affected knee is subjected to an MRI T2 mapping examination to see the condition of cartilage
Single Bundle ACL Reconstruction
Arthroscopy Single Bundle ACL Reconstruction is a procedure to reconstruct the ACL using one bundle.
The procedure uses Hamstring (Gracillis muscle and Semitendinosus muscle) as a graft.
Double Bundle ACL Reconstruction
Arthroscopy Double Bundle ACL Reconstruction is a procedure to reconstruct the ACL using Two bundles (Double bundle).
The procedure uses Gracillis tendon as a Posterolateral bundle graft and Semitendinosus tendon as an Anteromedial bundle graft.
Instability Examination
Lachmant Test, Pivot shift test and Rolimeter Measurement
Single Bundle ACL Reconstruction
Arthroscopy Single Bundle ACL Reconstruction is a procedure to reconstruct the ACL using one bundle.
The procedure uses Hamstring (Gracillis muscle and Semitendinosus muscle) as a graft.
Double Bundle ACL Reconstruction
Arthroscopy Double Bundle ACL Reconstruction is a procedure to reconstruct the ACL using Two bundles (Double bundle).
The procedure uses Gracillis tendon as a Posterolateral bundle graft and Semitendinosus tendon as an Anteromedial bundle graft.
Interventions
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Single Bundle ACL Reconstruction
Arthroscopy Single Bundle ACL Reconstruction is a procedure to reconstruct the ACL using one bundle.
The procedure uses Hamstring (Gracillis muscle and Semitendinosus muscle) as a graft.
Double Bundle ACL Reconstruction
Arthroscopy Double Bundle ACL Reconstruction is a procedure to reconstruct the ACL using Two bundles (Double bundle).
The procedure uses Gracillis tendon as a Posterolateral bundle graft and Semitendinosus tendon as an Anteromedial bundle graft.
Eligibility Criteria
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Inclusion Criteria
* Age 18-40 years
* Total primary ACL rupture
* Injury time 1-12 months
* Willingness to attend the study
* Signed informed consent.
Exclusion Criteria
* History of rheumatoid arthritis
* Severe osteoarthritis Kellgren-Lawrence grading\> 2
* Body Mass Index (BMI) ≥ 25
* Fracture around the knee joint or osteochondral avulsion
* History of injury with either or both semitendinosus or gracilis muscle, patellofemoral instability, contraindication of anesthesia, and partial ACL rupture.
18 Years
40 Years
MALE
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Ismail Hadisoebroto Dilogo
Professor in Faculty of Medicine
Principal Investigators
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Bobby N Nelwan, MD
Role: PRINCIPAL_INVESTIGATOR
Fakultas Kedokteran Universitas Indonesia
Locations
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Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Bobby N Nelwan, MD
Role: primary
Aryo N Triyudanto, MD
Role: backup
Other Identifiers
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ISMBNNCARTRECON
Identifier Type: -
Identifier Source: org_study_id