- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02425995
Interest of Additional Arthroscopic Portals in Diagnosis of Hidden Lesions of the Medial Meniscus in Pediatrics Knees With ACL Deficiency
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France
- Hospices Civils de Lyon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of hidden lesions diagnosed in Arthroscopic Posteromedial Portal and not seen in classic arthroscopic portals and Intercondylar Portal.
Time Frame: Day 1 (during surgery)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of hidden lesions diagnosed during the arthroscopic procedure and not seen in preoperatively MRI.
Time Frame: Day 1 (during surgery)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Franck CHOTEL, Pr, Service de Chirurgie Orthopédique Pédiatrique - Hôpital Femme Mère Enfant - 59, Bd Pinel 69677 BRON CEDEX
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL14_0358
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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