Anterior Cruciate Ligament Rupture Clinical Trial
— ACLOfficial title:
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
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.
Status | Recruiting |
Enrollment | 52 |
Est. completion date | June 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Male - Age 18-40 years - Total primary ACL rupture - Injury time 1-12 months - Willingness to attend the study - Signed informed consent. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Fakultas Kedokteran Universitas Indonesia | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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