Anterior Cruciate Ligament RuptureACLNCT04626999
Single and Double Bundle ACL Reconstructions, in Term of Cartilage Damage Due to Remaining Instability After Surgery.
A study testing Single Bundle ACL Reconstruction and Double Bundle ACL Reconstruction in people with Anterior Cruciate Ligament Rupture and Knee Instability, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Knee Instability, Cartilage Damage
- What is being tested?
- Single Bundle ACL Reconstruction and Double Bundle ACL Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Jan 2018to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- Age 18-40 years
- Total primary ACL rupture
- Injury time 1-12 months
- Willingness to attend the study
- Signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ismail H Dilogo, MD, PhD contact
Indonesia1 site, 1 recruiting
- Recruiting
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
Bobby N Nelwan, MD, +62811898464, bobbynelwan@gmail.com
Aryo N Triyudanto, MD, +628119629571, nugroho.triyudanto@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- Single Bundle ACL Reconstruction, Double Bundle ACL Reconstruction
- 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
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Pseudoachondroplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Bundle ACL ReconstructionProcedure or surgery
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 ReconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Synovial fluid COMP | Active comparator | Knee joint fluid is aspirated for ELISA COMP examination Receives: Procedure: Single Bundle ACL Reconstruction; Procedure: Double Bundle ACL Reconstruction |
| MRI T2 Mapping | Active comparator | Affected knee is subjected to an MRI T2 mapping examination to see the condition of cartilage Receives: Procedure: Single Bundle ACL Reconstruction; Procedure: Double Bundle ACL Reconstruction |
| Instability Examination | Active comparator | Lachmant Test, Pivot shift test and Rolimeter Measurement Receives: Procedure: Single Bundle ACL Reconstruction; Procedure: Double Bundle ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 0,3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start8 Jan 2018
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Hadisoebroto Dilogo, Universitas Indonesia
- Investigators
- Bobby N Nelwan, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626999
- Sponsor's protocol ID
- ISMBNNCARTRECON
- Acronym
- ACL
- Status last verified
- Nov 2020
- First submitted
- 22 Oct 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04626999
- Acronym / sponsor ID
- ACL / ISMBNNCARTRECON
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Synovial fluid COMP | Active comparator | Procedure: Single Bundle ACL Reconstruction, Procedure: Double Bundle ACL ReconstructionKnee joint fluid is aspirated for ELISA COMP examination |
| MRI T2 Mapping | Active comparator | Procedure: Single Bundle ACL Reconstruction, Procedure: Double Bundle ACL ReconstructionAffected knee is subjected to an MRI T2 mapping examination to see the condition of cartilage |
| Instability Examination | Active comparator | Procedure: Single Bundle ACL Reconstruction, Procedure: Double Bundle ACL ReconstructionLachmant Test, Pivot shift test and Rolimeter Measurement |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Age 18-40 years
- Total primary ACL rupture
- Injury time 1-12 months
- Willingness to attend the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Bundle ACL ReconstructionArthroscopy 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 or surgery | Instability Examination, MRI T2 Mapping, Synovial fluid COMP |
| Double Bundle ACL ReconstructionArthroscopy 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. | Procedure or surgery | Instability Examination, MRI T2 Mapping, Synovial fluid COMP |
Primary outcome
Changes of Synovial fluid Cartilage Oligomeric Matrix Protein (sfCOMP) Concentration from Baseline to 3 months and 6 months
Time frame: 0,3,6 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.
Changes of MRI T2 Mapping colour from Baseline to 3 months and 6 months
Time frame: 0,3,6 months
The cartilage of the affected knee will be checked using MRI T2 Mapping and the resulting color will be quantitatively assessed in seconds.
Changes of Lachman test score from baseline to 3 months and 6 months
Time frame: 0,3,6 months
Anterior instability on the affected knee will be checked using the Lachman test and the score is recorded in millimeter (mm).
Changes of Pivot shift test score from baseline to 3 months and 6 months
Time frame: 0,3,6 months
Rotatory instability on the affected knee will be checked using the Pivot shift test and the score is recorded in +1, +2, +3.
Changes of Rolimeter measurement score from baseline to 3 months and 6 months
Time frame: 0,3,6 months
Anterior instability on the affected knee will be checked using the Rolimeter tools and the measurement is recorded in millimeter (mm).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
Related trials for Anterior Cruciate Ligament Rupture
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail H Dilogo, MD, PhD contact
Bobby N Nelwan, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Bundle ACL Reconstruction and Double Bundle ACL Reconstruction in people with Anterior Cruciate Ligament Rupture and Knee Instability, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bobby N Nelwan (+62811898464, bobbynelwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Synovial fluid Cartilage Oligomeric Matrix Protein (sfCOMP) Concentration from Baseline to 3 months and 6 months (time frame: 0,3,6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.