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RecruitingNCT06222814Updated Jan 25, 2024

Evaluation of the Results of Two Different Methods in Management of Antero-lateral Instability of the Knee

An interventional study of ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft and ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire) in Anterior Cruciate Ligament Injuries, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-01-25.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Sep 2023, registered Jan 2024).
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Anterior Cruciate Ligament Injuries
03

In context

Anterior Cruciate Ligament Injuries

512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.

This study's planned enrollment of 40 is below the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The ACL deficient knee was clinically manifested by physical examination and confirmed by MRI.
  2. Age 18-45 years, skeletally mature patient.
  3. A positive pivot shift test of at least grade II is required (significant anterolateral instability).

Exclusion criteria

Exclusion Criteria:

  1. Multiple ligament injuries or a polytraumatized patient
  2. Revision cases.
  3. Generalized laxity.
  4. Symptomatic articular cartilage defect requiring treatment; Outerbridge > grade II.
  5. More than three degrees of varus or valgus malalignment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Reconstruction group

    Patients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft

    Procedure: ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft

  • Active comparator
    Tenodesis group

    Patients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire).

    Procedure: ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)

Interventions

  • ProcedureACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft

    ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft

  • ProcedureACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)

    ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)

06

What researchers measure

Primary outcomes

  1. Functional results of knee stability and return to normal activity

    IKDC (International Knee Documentation Committee) subjective knee evaluation form

    Time frame: 12 months postoperatively

07

Study locations

1 of 1 sites recruiting
  • Sohag University
    Sohag, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06222814
Lead sponsor
Sohag University
Responsible party
Omar Mohamed Abdelkareem (Assistant lecturer, Sohag University) — Principal investigator
First posted
Jan 25, 2024
Start date
Sep 1, 2023
Primary completion
Aug 31, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Jan 25, 2024

Study contacts

Omar Abdelkarim, Master
Contact
omar.ortho89@gmail.com
01008016681
Mohamed Ali, MD
Contact
mohamed.ali@yahoo.com
01011954560
Abdelrahman Hafez, MD
study chair · Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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