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CompletedNCT05962580Updated Jul 27, 2023

Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Among High Demand Patients

An interventional study of Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis and Isolated anterior cruciate ligament reconstruction only in Anterior Cruciate Ligament Tear, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Feb 2021, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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)

02

Conditions studied

  • Anterior Cruciate Ligament Tear

Keywords

  • anterior cruciate ligament tear
  • anterolateral instability
  • retear
  • extra articular tenodesis
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 enrollment of 20 is below the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. History of knee traumatic event.
    2. Clinical examination ( positive Lachman test and pivot shift test).
    3. Radiological evidence of ACL tear by MRI.
  • patient with high pivot shift test.

Exclusion criteria

Exclusion Criteria:

  • 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
  • Patients with malalignment ( genu varum, genu valgum or genu recurvatum )
  • Neuromuscular disorders
  • Knee arthritic changes.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis

    Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction with modified Lemiere technique for extra-articular tenodesis

    Procedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis

  • Active comparator
    Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis

    Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only

    Procedure: Isolated anterior cruciate ligament reconstruction only

Interventions

  • ProcedureIsolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis

    Anatomical single bundle ACLR with modified Lemiere technique

  • ProcedureIsolated anterior cruciate ligament reconstruction only

    arthroscopic anatomical single bundle ACL Reconstruction

06

What researchers measure

Primary outcomes

  1. failure rate

    retear of ACL graft confirmed by clinical examination and MRI

    Time frame: one year follow up

Secondary outcomes

  1. 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)

    Time frame: at 3,6,9,12 months

  2. 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)

    Time frame: at 3,6,9,12 months

  3. antero-posterior instability measure

    measure AP instability by KT1000 lachmeter for injured and non injured knee

    Time frame: at 3,6,9 and 12 months

  4. side to side KT 1000 lachmeter difference

    measure side to side KT 1000 lachmeter difference by (injured - noninjured)

    Time frame: one year follow up

07

Study locations

1 site
  • Ahmed Abdel Salam Abdel Halim
    Cairo, Abbasia 11539, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05962580
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Feb 15, 2021
Primary completion
Feb 15, 2022
Completion
Mar 1, 2023
Last update
Jul 27, 2023

Study contacts

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
Yehia Mo Haroun, Lecturer
study director · Faculty of medecine, Ain shams university
Ahmed Ab Amer, Msc
principal investigator · Faculty of medecine, Ain shams university

Oversight

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

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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