Single and Double Bundle ACL Reconstructions, in Term of Cartilage Damage Due to Remaining Instability After Surgery.
ACL
Effect of Knee Instability Due To Rupture Of Anterior Cruciate Ligament On Cartilage Damage Related To Types of Reconstruction Therapy: In Biomechanic, Biomolecular and Radiological Aspects
1 other identifier
interventional
52
1 country
1
Brief Summary
The prevalence of ACL (Anterior Cruciate Ligament) ruptures is relatively high, primarily due to sports and military training injuries. With the advancements of ACL reconstruction therapies, there exist two ways to reconstruct ACL: single-bundle ACL reconstruction (SBACLR) and double-bundle ACL reconstruction (DBACLR). Previous research studies claimed that DBACLR techniques are superior to that of SBACLR, while others stated no notable differences between the two. The variables assessed in previous studies are findings related to the clinical instabilities of the knees (both subjective nor objectives views) and standard radiology examination, such as Xray or MRI. Knee instabilities are the primary goal of ACL reconstructions. Hence this study focuses on finding the dissimilarities between the two previously mentioned techniques by observing the early consequences (subclinically) of knee instabilities towards cartilage damage. The dissimilarities assessments utilize biomolecular tests (ELISA) of cartilage oligomeric matrix protein (COMP) on synovial joint fluid of the knee and knee joint cartilage examination using MRI T2 mapping. Furthermore, there will be a stability (biomechanical) check of the knee joint in the form of a Lachman test, a pivot shift test, and a Rolimeter. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2018
CompletedFirst Submitted
Initial submission to the registry
October 22, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedNovember 13, 2020
November 1, 2020
3.4 years
October 22, 2020
November 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Changes of Synovial fluid Cartilage Oligomeric Matrix Protein (sfCOMP) Concentration from Baseline to 3 months and 6 months
Sample will be taken from Synovial fluid and and send to laboratory for checking the concentration (ng/mL) of COMP using ELISA (enzyme-linked immunosorbent assay) kits.
0,3,6 months
Changes of MRI T2 Mapping colour from Baseline to 3 months and 6 months
The cartilage of the affected knee will be checked using MRI T2 Mapping and the resulting color will be quantitatively assessed in seconds.
0,3,6 months
Changes of Lachman test score from baseline to 3 months and 6 months
Anterior instability on the affected knee will be checked using the Lachman test and the score is recorded in millimeter (mm).
0,3,6 months
Changes of Pivot shift test score from baseline to 3 months and 6 months
Rotatory instability on the affected knee will be checked using the Pivot shift test and the score is recorded in +1, +2, +3.
0,3,6 months
Changes of Rolimeter measurement score from baseline to 3 months and 6 months
Anterior instability on the affected knee will be checked using the Rolimeter tools and the measurement is recorded in millimeter (mm).
0,3,6 months
Study Arms (3)
Synovial fluid COMP
ACTIVE COMPARATORKnee joint fluid is aspirated for ELISA COMP examination
MRI T2 Mapping
ACTIVE COMPARATORAffected knee is subjected to an MRI T2 mapping examination to see the condition of cartilage
Instability Examination
ACTIVE COMPARATORLachmant Test, Pivot shift test and Rolimeter Measurement
Interventions
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.
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
You may qualify if:
- Male
- Age 18-40 years
- Total primary ACL rupture
- Injury time 1-12 months
- Willingness to attend the study
- Signed informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bobby N Nelwan, MD
Fakultas Kedokteran Universitas Indonesia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Faculty of Medicine
Study Record Dates
First Submitted
October 22, 2020
First Posted
November 13, 2020
Study Start
January 8, 2018
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
November 13, 2020
Record last verified: 2020-11