Clinical trial NCT04626999: Single and Double Bundle ACL Reconstructions, in Term of Cartilage Damage Due to Remaining Instability After Surgery.
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Knee Instability
Cartilage Damage
Keywords: knee instability
anterior cruciate ligament rupture
cartilage damage
Single Bundle ACL Reconstruction
Double Bundle ACL Reconstruction
COMP (Cartilage Oligomeric Matrix Protein)
MRI T2 Mapping
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study utilizes a single-blind randomized clinical trial to evaluate whether the DBACL reconstruction surgery is more suitable than SBACL reconstruction in the subclinical aspect of cartilage damage through a biomolecular examination from the synovial joint fluid COMP and MRI T2 mapping.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of Synovial fluid Cartilage Oligomeric Matrix Protein (sfCOMP) Concentration from Baseline to 3 months and 6 months
timeFrame: 0,3,6 months
measure: Changes of MRI T2 Mapping colour from Baseline to 3 months and 6 months
timeFrame: 0,3,6 months
measure: Changes of Lachman test score from baseline to 3 months and 6 months
timeFrame: 0,3,6 months
measure: Changes of Pivot shift test score from baseline to 3 months and 6 months
timeFrame: 0,3,6 months
measure: Changes of Rolimeter measurement score from baseline to 3 months and 6 months
timeFrame: 0,3,6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Fakultas Kedokteran Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Bobby N Nelwan, MD
role: PRINCIPAL_INVESTIGATOR
References: