Anterior Cruciate Ligament TearNCT05962580
Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Among High Demand Patients
A study testing Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis and Isolated anterior cruciate ligament reconstruction only in people with Anterior Cruciate Ligament Tear, run by Ain Shams University at 1 site in Egypt.
Trial summary
Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis between high demand patients Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis and Isolated anterior cruciate ligament reconstruction only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2021to 1 Mar 2023
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- High demand patients (manual workers, athletes,...etc.).
- Normal average body mass index ( 18.5 - 24.9 ).
- Age <40 years old.
- Patients will be diagnosed as ACL tear by the following:
- History of knee traumatic event.
- Clinical examination ( positive Lachman test and pivot shift test).
- Radiological evidence of ACL tear by MRI.
- patient with high pivot shift test.
Who cannot join
- Generalized ligamentous laxity.
- Other intra or extra articular knee injuries.
- Previous ACL surgery on the affected knee.
- Bilateral ACL injuries.
- Significant Articular surface injury.
- Medical comorbidities
Show all 9Show fewer
- Patients with malalignment ( genu varum, genu valgum or genu recurvatum )
- Neuromuscular disorders
- Knee arthritic changes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: of Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Between High Demand Patients: Randomized Controlled Trial
Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis between high demand patients
Read the detailed description
It is a randomized control trial comparing between isolated anterior cruciate ligament reconstruction with and without lateral extra articular tenodesis between high demand and high risk groups with high pivot regarding failure rate (primary out come) and patient reported functions score (IKDC and Lysholm)
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis, Isolated anterior cruciate ligament reconstruction only
- Keywords
- anterior cruciate ligament tear, anterolateral instability, retear, extra articular tenodesis
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesisProcedure or surgery
Anatomical single bundle ACLR with modified Lemiere technique
Isolated anterior cruciate ligament reconstruction onlyProcedure or surgery
arthroscopic anatomical single bundle ACL Reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis | Experimental | Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction with modified Lemiere technique for extra-articular tenodesis Receives: Procedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis |
| Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis | Active comparator | Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only Receives: Procedure: Isolated anterior cruciate ligament reconstruction only |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure rate
retear of ACL graft confirmed by clinical examination and MRI
Measured: one year follow up
Secondary outcomes (4)
International knee documentation committee score (IKDC)
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
Measured: at 3,6,9,12 months
Lysholm score
The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Physicians use this condition-specific, subjective outcome score to assess patient progress after surgery or injury to the knee. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
Measured: at 3,6,9,12 months
antero-posterior instability measure
measure AP instability by KT1000 lachmeter for injured and non injured knee
Measured: at 3,6,9 and 12 months
side to side KT 1000 lachmeter difference
measure side to side KT 1000 lachmeter difference by (injured - noninjured)
Measured: one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start15 Feb 2021
- Primary completion15 Feb 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amr Mo Abdelhady, Professor, Study chair, Faculty of medecine, Ain shams universityMohamed Ha Sobhey, Professor, Study director, Faculty of medecine, Ain shams universityMoustapha Al ElAbd, lecturer, Study director, Faculty of medecine, Ain shams universityYehia Mo Haroun, Lecturer, Study director, Faculty of medecine, Ain shams universityAhmed Ab Amer, Msc, Principal investigator, Faculty of medecine, Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962580
- Sponsor's protocol ID
- MD 13/2021
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- of Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Between High Demand Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05962580
- Acronym / sponsor ID
- MD 13/2021
- Conditions
- Anterior Cruciate Ligament Tear
- Keywords
- anterior cruciate ligament tear, anterolateral instability, retear, extra articular tenodesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 27 Jul 2023 (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.
Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis between high demand patients
Detailed description
It is a randomized control trial comparing between isolated anterior cruciate ligament reconstruction with and without lateral extra articular tenodesis between high demand and high risk groups with high pivot regarding failure rate (primary out come) and patient reported functions score (IKDC and Lysholm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis | Experimental | Procedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesisArthroscopic anatomical single bundle anterior cruciate ligament reconstruction with modified Lemiere technique for extra-articular tenodesis |
| Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis | Active comparator | Procedure: Isolated anterior cruciate ligament reconstruction onlyArthroscopic anatomical single bundle anterior cruciate ligament reconstruction only |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- High demand patients (manual workers, athletes,...etc.).
- Normal average body mass index ( 18.5 - 24.9 ).
- Age <40 years old.
- Patients will be diagnosed as ACL tear by the following:
- patient with high pivot shift test.
Key exclusion criteria (9 listed)
- Generalized ligamentous laxity.
- Other intra or extra articular knee injuries.
- Previous ACL surgery on the affected knee.
- Bilateral ACL injuries.
- Significant Articular surface injury.
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 |
|---|---|---|
| Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesisAnatomical single bundle ACLR with modified Lemiere technique | Procedure or surgery | Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis |
| Isolated anterior cruciate ligament reconstruction onlyarthroscopic anatomical single bundle ACL Reconstruction | Procedure or surgery | Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis |
Primary outcome
failure rate
Time frame: one year follow up
retear of ACL graft confirmed by clinical examination and MRI
4 secondary outcomes
International knee documentation committee score (IKDC)
Time frame: at 3,6,9,12 months
Lysholm score
Time frame: at 3,6,9,12 months
antero-posterior instability measure
Time frame: at 3,6,9 and 12 months
side to side KT 1000 lachmeter difference
Time frame: one year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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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.
Amr Mo Abdelhady, Professor study chair
Faculty of medecine, Ain shams university
Mohamed Ha Sobhey, Professor study director
Faculty of medecine, Ain shams university
Moustapha Al ElAbd, lecturer study director
Faculty of medecine, Ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis and Isolated anterior cruciate ligament reconstruction only in people with Anterior Cruciate Ligament Tear, run by Ain Shams University at 1 site in Egypt.
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 8 inclusion and 9 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: finished, as of the sponsor's last update on 27 Jul 2023. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failure rate (time frame: one year follow up). 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 27 Jul 2023.