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

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.

Study Overview

• Status: Unknown
• Conditions: Anterior Cruciate Ligament Rupture; Cartilage Damage; Knee Instability
• Intervention / Treatment: Procedure: Single Bundle ACL Reconstruction; Procedure: Double Bundle ACL Reconstruction

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.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bobby N Nelwan; Phone Number: +62811898464; Email: bobbynelwan@gmail.com
• Study Contact Backup: Name: Ismail H Dilogo, MD, PhD; Email: ismailortho@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Fakultas Kedokteran Universitas Indonesia
      • Contact: Bobby N Nelwan, MD; Phone Number: +62811898464; Email: bobbynelwan@gmail.com
      • Contact: Aryo N Triyudanto, MD; Phone Number: +628119629571; Email: nugroho.triyudanto@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Synovial fluid COMP; Knee joint fluid is aspirated for ELISA COMP examination	Procedure: 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.; Procedure: 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.
Active Comparator: MRI T2 Mapping; Affected knee is subjected to an MRI T2 mapping examination to see the condition of cartilage	Procedure: 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.; Procedure: 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.
Active Comparator: Instability Examination; Lachmant Test, Pivot shift test and Rolimeter Measurement	Procedure: 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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Bobby N Nelwan, MD, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: November 8, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 8, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: cartilage damage; knee instability; anterior cruciate ligament rupture; Single Bundle ACL Reconstruction; Double Bundle ACL Reconstruction; COMP (Cartilage Oligomeric Matrix Protein); MRI T2 Mapping
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: ISMBNNCARTRECON

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No