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ACL Versus ALL + ACL Study

Primary Purpose

Anterior Cruciate Ligament Injury, Ligament Rupture

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ACL plasty
ACL + ALL plasty
Sponsored by
Ascopharm Groupe Novasco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Privé Jean Mermoz - Centre Paul SantyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ACL plasty

ACL + ALL plasty

Arm Description

The surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure.

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.

Outcomes

Primary Outcome Measures

Ligament re-rupture rate
Clinical instability, laximetry, IRM

Secondary Outcome Measures

International Knee Documentation Committee Subjective Knee (IKDC) clinical score
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)
Tegner Lysholm score
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).
Rolimeter test
Antero-posterior laximetry
KiRA test
Rotatory laximetry
Knee radiography
Development of osteoarthritis signs
Knee injury and osteoarthritis outcome score (KOOS) clinical score
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

Full Information

First Posted
November 29, 2016
Last Updated
April 5, 2019
Sponsor
Ascopharm Groupe Novasco
Collaborators
Ramsay Générale de Santé
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1. Study Identification

Unique Protocol Identification Number
NCT03740022
Brief Title
ACL Versus ALL + ACL Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascopharm Groupe Novasco
Collaborators
Ramsay Générale de Santé

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury, Ligament Rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
592 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACL plasty
Arm Type
Active Comparator
Arm Description
The surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure.
Arm Title
ACL + ALL plasty
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ACL plasty
Intervention Description
standard ligamentoplasty by Kenneth Jones
Intervention Type
Procedure
Intervention Name(s)
ACL + ALL plasty
Intervention Description
standard ligamentoplasty and anterolateral plasty
Primary Outcome Measure Information:
Title
Ligament re-rupture rate
Description
Clinical instability, laximetry, IRM
Time Frame
3 years
Secondary Outcome Measure Information:
Title
International Knee Documentation Committee Subjective Knee (IKDC) clinical score
Description
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)
Time Frame
preoperatively, 1 year and 3 years
Title
Tegner Lysholm score
Description
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).
Time Frame
Preoperatively, 1 year and 3 years
Title
Rolimeter test
Description
Antero-posterior laximetry
Time Frame
pre-operatively, 6 months, 1 year and 3 years
Title
KiRA test
Description
Rotatory laximetry
Time Frame
preoperatively, 6 months and 3 years
Title
Knee radiography
Description
Development of osteoarthritis signs
Time Frame
preoperatively and 3 years
Title
Knee injury and osteoarthritis outcome score (KOOS) clinical score
Description
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
Time Frame
preoperative, 1 year and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SONNERY-COTTET Bertrand, Dr
Phone
+33 4 37 53 00 22
Email
sonnerycottet@aol.com
Facility Information:
Facility Name
Hôpital Privé Jean Mermoz - Centre Paul Santy
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SONNERY-COTTET Bertrand, Dr
Phone
+33 4 37 53 00 22
Email
sonnerycottet@aol.com
First Name & Middle Initial & Last Name & Degree
SONNERY-COTTET Bertrand, Dr
First Name & Middle Initial & Last Name & Degree
FAYARD Jean-Marie, Dr
First Name & Middle Initial & Last Name & Degree
THAUNAT Mathieu, Dr

12. IPD Sharing Statement

Citations:
PubMed Identifier
32490026
Citation
Sonnery-Cottet B, Pioger C, Vieira TD, Franck F, Kajetanek C, Fayard JM, Thaunat M, Saithna A. Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial. Orthop J Sports Med. 2020 May 1;8(5):2325967120918490. doi: 10.1177/2325967120918490. eCollection 2020 May.
Results Reference
derived

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ACL Versus ALL + ACL Study

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