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ACL Versus ALL + ACL Study

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ClinicalTrials.gov Identifier: NCT03740022
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Ramsay Générale de Santé
Information provided by (Responsible Party):
Ascopharm Groupe Novasco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Ligament Rupture Procedure: ACL plasty Procedure: ACL + ALL plasty Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 592 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Results of Combined Anterolateral Ligament (ALL) + Antero Crusader Ligament (ACL) Plasty Compared to Classical KJ Plasty in Isolated ACL Ruptures
Actual Study Start Date : November 2016
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Active Comparator: ACL plasty
The surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure.
Procedure: ACL plasty
standard ligamentoplasty by Kenneth Jones

Experimental: ACL + ALL plasty
The surgical procedure consists of a hamstring ligamentoplasty (DIDT) of the antero crusader ligament (ACL) and anterolateral ligament (ALL) according to a published arthroscopic procedure.
Procedure: ACL + ALL plasty
standard ligamentoplasty and anterolateral plasty




Primary Outcome Measures :
  1. Ligament re-rupture rate [ Time Frame: 3 years ]
    Clinical instability, laximetry, IRM


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740022


Contacts
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Contact: SONNERY-COTTET Bertrand, Dr +33 4 37 53 00 22 sonnerycottet@aol.com

Locations
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France
Hôpital Privé Jean Mermoz - Centre Paul Santy Recruiting
Lyon, France, 69008
Contact: SONNERY-COTTET Bertrand, Dr    +33 4 37 53 00 22    sonnerycottet@aol.com   
Principal Investigator: SONNERY-COTTET Bertrand, Dr         
Sub-Investigator: FAYARD Jean-Marie, Dr         
Sub-Investigator: THAUNAT Mathieu, Dr         
Sponsors and Collaborators
Ascopharm Groupe Novasco
Ramsay Générale de Santé

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Responsible Party: Ascopharm Groupe Novasco
ClinicalTrials.gov Identifier: NCT03740022     History of Changes
Other Study ID Numbers: 2016-A00144-47
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries