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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03740022
Other study ID # 2016-A00144-47
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date August 2022

Study information

Verified date April 2019
Source Ascopharm Groupe Novasco
Contact SONNERY-COTTET Bertrand, Dr
Phone +33 4 37 53 00 22
Email sonnerycottet@aol.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 592
Est. completion date August 2022
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
ACL plasty
standard ligamentoplasty by Kenneth Jones
ACL + ALL plasty
standard ligamentoplasty and anterolateral plasty

Locations

Country Name City State
France Hôpital Privé Jean Mermoz - Centre Paul Santy Lyon

Sponsors (2)

Lead Sponsor Collaborator
Ascopharm Groupe Novasco Ramsay Générale de Santé

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ligament re-rupture rate Clinical instability, laximetry, IRM 3 years
Secondary 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) preoperatively, 1 year and 3 years
Secondary 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). Preoperatively, 1 year and 3 years
Secondary Rolimeter test Antero-posterior laximetry pre-operatively, 6 months, 1 year and 3 years
Secondary KiRA test Rotatory laximetry preoperatively, 6 months and 3 years
Secondary Knee radiography Development of osteoarthritis signs preoperatively and 3 years
Secondary 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 preoperative, 1 year and 3 years
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