Anterior Cruciate Ligament InjuriesNCT06222814
Evaluation of the Results of Two Different Methods in Management of Antero-lateral Instability of the Knee
A study testing ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft and ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire) in people with Anterior Cruciate Ligament Injuries, run by Sohag University at 1 site in Egypt.
Trial summary
This randomized clinical study will be conducted to compare the results of anterior cruciate ligament reconstruction (ACLR) combined with either anterolateral ligament reconstruction using peroneus longus autograft or extra-articular tenodesis (Modified Lemaire) in management of antero-lateral instability of the knee Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft and ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 31 Aug 2025
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The ACL deficient knee was clinically manifested by physical examination and confirmed by MRI.
- Age 18-45 years, skeletally mature patient.
- A positive pivot shift test of at least grade II is required (significant anterolateral instability).
Who cannot join
- Multiple ligament injuries or a polytraumatized patient
- Revision cases.
- Generalized laxity.
- Symptomatic articular cartilage defect requiring treatment; Outerbridge > grade II.
- More than three degrees of varus or valgus malalignment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Mohamed Ali, MD, 01011954560, omar_smsa@yahoo.com
About this study
This randomized clinical study will be conducted to compare the results of anterior cruciate ligament reconstruction (ACLR) combined with either anterolateral ligament reconstruction using peroneus longus autograft or extra-articular tenodesis (Modified Lemaire) in management of antero-lateral instability of the knee
Read the detailed description
Patients will undergo an anatomic ACLR in a standardized fashion by the same team of surgeons. They are randomly divided into 2 groups either ACLR plus ALL reconstruction or ACLR combined with LET in a 1:1 ratio. There are multiple graft options for ACL-R, but here for the study, the hamstring autograft is harvested following the traditional technique. The graft is measured and bony tunnels are drilled. An anatomical reconstruction technique is used in all cases.
In group A: the surgeon will harvest peroneus longus graft, then sutured to the double bundle hamstring graft. The graft diameters are measured and recorded. The graft is pulled through the femoral tunnel and passed through the tibial tunnel. The single portion of the graft is passed freely through the tibial and femoral tunnels until the quintuple graft portion occupies both tunnels. The graft is then pulled, and an interference screw (Smith \& Nephew Endoscopy) is fixed to the femur. The next step is to fix the inferior end of the quintuple graft to the tibia after pre-tensioning. After tibial fixation, the remaining PL is passed through the subcutaneous and ALL tunnels. The ligament is fixed under traction, mild valgus stress, and 30' of flexion 1.5 cm from the joint line into a midpoint between Gerdy's tubercle and the fibular head.
In group B: the surgeon will use a triple STG hamstring (6- strands) tendon graft. The graft diameters are measured and recorded.
Then, LET is performed in a standardized fashion as described in the modified Lemaire technique. LET is fixed with interference screws (Smith \& Nephew Endoscopy). Femoral and tibial fixations are performed with bio-absorbable interference screws (Smith \& Nephew Endoscopy).
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft, ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)
- 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.
ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograftProcedure or surgery
ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft
ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)Procedure or surgery
ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)
| Study group | Role | What they receive |
|---|---|---|
| Reconstruction group | Active comparator | Patients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft Receives: Procedure: ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft |
| Tenodesis group | Active comparator | Patients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire). Receives: Procedure: ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional results of knee stability and return to normal activity
IKDC (International Knee Documentation Committee) subjective knee evaluation form
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Sep 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Abdelkareem, Sohag University
- Investigators
- Abdelrahman Hafez, MD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222814
- Sponsor's protocol ID
- Soh-Med-23-12-12MS
- Status last verified
- Jan 2024
- First submitted
- 1 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Azab H, Abdelkareem O, Hafez AR, Elsayed M, Ali M. Comparative study between lateral extra-articular tenodesis versus anterolateral ligament reconstruction in combination with anterior cruciate ligament reconstruction. J Orthop Surg Res. 2026 Jan 17;21(1):52. doi: 10.1186/s13018-025-06561-x.
PubMed 41547885
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Results of Two Different Methods in Management of Antero-lateral Instability of the Knee
- ClinicalTrials.gov ID
- NCT06222814
- Acronym / sponsor ID
- Soh-Med-23-12-12MS
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 25 Jan 2024 (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.
This randomized clinical study will be conducted to compare the results of anterior cruciate ligament reconstruction (ACLR) combined with either anterolateral ligament reconstruction using peroneus longus autograft or extra-articular tenodesis (Modified Lemaire) in management of antero-lateral instability of the knee
Detailed description
Patients will undergo an anatomic ACLR in a standardized fashion by the same team of surgeons. They are randomly divided into 2 groups either ACLR plus ALL reconstruction or ACLR combined with LET in a 1:1 ratio. There are multiple graft options for ACL-R, but here for the study, the hamstring autograft is harvested following the traditional technique. The graft is measured and bony tunnels are drilled. An anatomical reconstruction technique is used in all cases.
In group A: the surgeon will harvest peroneus longus graft, then sutured to the double bundle hamstring graft. The graft diameters are measured and recorded. The graft is pulled through the femoral tunnel and passed through the tibial tunnel. The single portion of the graft is passed freely through the tibial and femoral tunnels until the quintuple graft portion occupies both tunnels. The graft is then pulled, and an interference screw (Smith \& Nephew Endoscopy) is fixed to the femur. The next step is to fix the inferior end of the quintuple graft to the tibia after pre-tensioning. After tibial fixation, the remaining PL is passed through the subcutaneous and ALL tunnels. The ligament is fixed under traction, mild valgus stress, and 30' of flexion 1.5 cm from the joint line into a midpoint between Gerdy's tubercle and the fibular head.
In group B: the surgeon will use a triple STG hamstring (6- strands) tendon graft. The graft diameters are measured and recorded.
Then, LET is performed in a standardized fashion as described in the modified Lemaire technique. LET is fixed with interference screws (Smith \& Nephew Endoscopy). Femoral and tibial fixations are performed with bio-absorbable interference screws (Smith \& Nephew Endoscopy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reconstruction group | Active comparator | Procedure: ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograftPatients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft |
| Tenodesis group | Active comparator | Procedure: ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)Patients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The ACL deficient knee was clinically manifested by physical examination and confirmed by MRI.
- Age 18-45 years, skeletally mature patient.
- A positive pivot shift test of at least grade II is required (significant anterolateral instability).
Key exclusion criteria (5 listed)
- Multiple ligament injuries or a polytraumatized patient
- Revision cases.
- Generalized laxity.
- Symptomatic articular cartilage defect requiring treatment; Outerbridge > grade II.
- More than three degrees of varus or valgus malalignment
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 |
|---|---|---|
| ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograftACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft | Procedure or surgery | Reconstruction group |
| ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire) | Procedure or surgery | Tenodesis group |
Primary outcome
Functional results of knee stability and return to normal activity
Time frame: 12 months postoperatively
IKDC (International Knee Documentation Committee) subjective knee evaluation form
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 41547885El-Azab H, Abdelkareem O, Hafez AR, Elsayed M, Ali M. Comparative study between lateral extra-articular tenodesis versus anterolateral ligament reconstruction in combination with anterior cruciate ligament reconstruction. J Orthop Surg Res. 2026 Jan 17;21(1):52. doi: 10.1186/s13018-025-06561-x.
- Individual participant dataSharing planned: No
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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.
Abdelrahman Hafez, MD study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft and ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire) in people with Anterior Cruciate Ligament Injuries, run by Sohag 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 3 inclusion and 5 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 25 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Abdelkarim, Master (01008016681, omar.ortho89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional results of knee stability and return to normal activity (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06222814, which also lists 1 linked publication.
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 25 Jan 2024.