Interest of Additional Arthroscopic Portals in Diagnosis of Hidden Lesions of the Medial Meniscus in Pediatrics Knees With ACL Deficiency

Chronic Knee Instability Clinical Trial

Official title:

Prevalence and Diagnosis of Hidden Lesions of the Posterior Horn of the Medial Meniscus in Pediatric Anterior Cruciate Ligament (ACL) Lesions : Interest of Arthroscopic Intercondylar and Posteromedial Portals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425995
• Other study ID #: 69HCL14_0358
• Status: Completed
• Phase: N/A
• First received: April 15, 2015
• Last updated: October 3, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Peroperatively observative study in pediatric orthopedic center in Lyon, France.

50 pediatric patients included in this study, to improve the diagnosis of hidden lesions of the medial meniscus associated with lesions of the anterior cruciate ligament.

All the patients need a reconstruction of the ACL because of chronic knee instability.

All the patients underwent a multi portal arthroscopy during the ACL reconstruction :

anteromedial and anterolateral and after intercondylar and posteromedial.

The study consists in a peroperatively arthroscopic look, in order to diagnose lesions of the posterior horn of the medial meniscus which could be missed in MRI and anteromedial and anterolateral arthroscopy.

Statistics of this lesions are used to study prevalence and diagnosis capacity of this procedures.

First, the surgeon did a classic knee arthroscopy. Secondarily, he did an intercondylar portal and after a posteromedial portal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Chronic knee instability with indicated surgery reconstruction

Exclusion Criteria:

• Pregnancy

• No preoperatively knee MRI

• Posteromedial or Intercondylar Portal Failure

• Social security system membership failure

• Refusal of consent of child or parents

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Knee Instability

Intervention

Procedure:
• Arthroscopic intercondylar and posteromedial portal
Diagnosis of lesions of the Posterior Horn of the Medial Meniscus in Arthroscopic intercondylar and posteromedial portal in addition with standard ACL reconstruction, during the same surgery.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hidden lesions diagnosed in Arthroscopic Posteromedial Portal and not seen in classic arthroscopic portals and Intercondylar Portal.	Diagnosis of a hidden lesion of the Posterior Horn of the Medial Meniscus in Arthroscopic Posteromedial Portal, which has not be seen in classic arthroscopic portals and Intercondylar Portal.	Day 1 (during surgery)	No
Secondary	Number of hidden lesions diagnosed during the arthroscopic procedure and not seen in preoperatively MRI.	Diagnosis of a hidden lesion of the posterior horn of the medial meniscus during the arthroscopic procedure, lesion not seen in preoperatively MRI.	Day 1 (during surgery)	No