ACL Versus ALL + ACL Study

April 5, 2019 updated by: Ascopharm Groupe Novasco

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

592

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69008
        • Recruiting
        • Hôpital Privé Jean Mermoz - Centre Paul Santy
        • Contact:
        • Principal Investigator:
          • SONNERY-COTTET Bertrand, Dr
        • Sub-Investigator:
          • FAYARD Jean-Marie, Dr
        • Sub-Investigator:
          • THAUNAT Mathieu, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ligament re-rupture rate
Time Frame: 3 years
Clinical instability, laximetry, IRM
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
preoperatively, 1 year and 3 years
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).
Preoperatively, 1 year and 3 years
Rolimeter test
Time Frame: pre-operatively, 6 months, 1 year and 3 years
Antero-posterior laximetry
pre-operatively, 6 months, 1 year and 3 years
KiRA test
Time Frame: preoperatively, 6 months and 3 years
Rotatory laximetry
preoperatively, 6 months and 3 years
Knee radiography
Time Frame: preoperatively and 3 years
Development of osteoarthritis signs
preoperatively and 3 years
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
preoperative, 1 year and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascopharm Groupe Novasco

Collaborators

Ramsay Générale de Santé

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

November 9, 2018

First Posted (Actual)

November 14, 2018

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00144-47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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