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NCT Number: NCT03740022

ACL Versus ALL + ACL Study

The aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique.

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Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Ligament Rupture Wounds and Injuries

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Jean Mermoz - Centre Paul Santy

Lyon, 69008, France

About this study

The aim is to evaluate the rate of re-rupture and to analyze knee function through scores analysis as International Knee Documentation Committee Subjective Knee (IKDC), Knee injury and osteoarthritis outcome score (KOOS), Lysholm-Tegner, and by objective measurements of laximetry and rotation.

This study should include 2 groups of 296 patients with isolated ACL (antero crusader ligament) with clinical rotation :

  • operated by a conventional patellar tendon technique (first group)
  • operated by a technique combining a ALL (anterolateral ligament) and ACL plasty for the second group

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with total isolated antero crusader ligament (ACL) rupture who are candidates for surgical reconstruction
  • Patients between 18 and 35 years old
  • Patients with weekly sporting activities
  • Patients with chronic rotatory instability with a positive pivot shift
  • Patients who have been informed and do not object the research

Exclusion criteria

  • Patients with multi-ligament knee involvement
  • Patients under 18 years old or over 35 years old
  • Patients with a BMI of under 18.5 or over 30
  • Patients with any contraindication to general anaesthesia
  • Professional sportsmen/women
  • Patients with congenital malformation or a rheumatic disease
  • Patients with repeated antero crusader ligament (ACL) rupture
  • Patients with serious ligament disease in the contralateral knee
  • Patients who refuse to take part in the study

Treatment and study plan

ACL plasty

Procedure

standard ligamentoplasty by Kenneth Jones

ACL + ALL plasty

Procedure

standard ligamentoplasty and anterolateral plasty

Primary outcomes

  1. Ligament re-rupture rate

    Time frame: 3 years

    Clinical instability, laximetry, IRM

Secondary outcomes

  1. International Knee Documentation Committee Subjective Knee (IKDC) clinical score

    Time frame: preoperatively, 1 year and 3 years

    International Knee Documentation Committee Subjective Knee allows a subjective assessment including symptoms, activity and knee function; is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100 (no limitation with activities of daily living or sports activities and the absence of symptoms)

  2. Tegner Lysholm score

    Time frame: Preoperatively, 1 year and 3 years

    Specific knee questionnaire : patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).

  3. Rolimeter test

    Time frame: pre-operatively, 6 months, 1 year and 3 years

    Antero-posterior laximetry

  4. KiRA test

    Time frame: preoperatively, 6 months and 3 years

    Rotatory laximetry

  5. Knee radiography

    Time frame: preoperatively and 3 years

    Development of osteoarthritis signs

  6. Knee injury and osteoarthritis outcome score (KOOS) clinical score

    Time frame: preoperative, 1 year and 3 years

    Knee injury and osteoarthritis outcome score is a specific knee questionnaire which evaluates : pain, symptoms, knee function in daily life, knee function in sport practice and quality of life. Scale : None (0) Mild Moderate Severe Extreme (4) Each subscale score is calculated independently. Calculate the mean score of the individual items of each subscale and divide by 4. Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems

Sponsors and collaborators

Lead sponsor

Ascopharm Groupe Novasco

Other

Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Registry information

Official study title

Assessment of the Results of Combined Anterolateral Ligament (ALL) + Antero Crusader Ligament (ACL) Plasty Compared to Classical KJ Plasty in Isolated ACL Ruptures

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2018
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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