Chronic Knee InstabilityNCT02425995
Interest of Additional Arthroscopic Portals in Diagnosis of Hidden Lesions of the Medial Meniscus in Pediatrics Knees With ACL Deficiency
A study testing Arthroscopic intercondylar and posteromedial portal in people with Chronic Knee Instability, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Chronic Knee Instability
- What is being tested?
- Arthroscopic intercondylar and posteromedial portal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chronic knee instability with indicated surgery reconstruction
Who cannot join
- Pregnancy
- No preoperatively knee MRI
- Posteromedial or Intercondylar Portal Failure
- Social security system membership failure
- Refusal of consent of child or parents
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Chronic Knee Instability
- Being tested
- Arthroscopic intercondylar and posteromedial portal
- Keywords
- ACL, Hidden lesions of the medial meniscus, Chronic knee instability, Intercondylar and posteromedial arthroscopy, Arthroscopic Posteromedial and Intercondylar portal, Diagnosis capacity of hidden lesions of the medial meniscus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic intercondylar and posteromedial portalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic intercondylar and posteromedial portal | Experimental | Not described Receives: Procedure: Arthroscopic intercondylar and posteromedial portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (during surgery)
Secondary outcomes (1)
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.
Measured: Day 1 (during surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee InstabilityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck CHOTEL, Pr, Principal investigator, Service de Chirurgie Orthopédique Pédiatrique - Hôpital Femme Mère Enfant - 59, Bd Pinel 69677 BRON CEDEX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425995
- Sponsor's protocol ID
- 69HCL14_0358
- Status last verified
- Oct 2016
- First submitted
- 15 Apr 2015
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02425995
- Acronym / sponsor ID
- 69HCL14_0358
- Conditions
- Chronic Knee Instability
- Keywords
- ACL, Hidden lesions of the medial meniscus, Chronic knee instability, Intercondylar and posteromedial arthroscopy, Arthroscopic Posteromedial and Intercondylar portal, Diagnosis capacity of hidden lesions of the medial meniscus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic intercondylar and posteromedial portal | Experimental | Procedure: Arthroscopic intercondylar and posteromedial portal |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Chronic knee instability with indicated surgery reconstruction
Key exclusion criteria (5 listed)
- Pregnancy
- No preoperatively knee MRI
- Posteromedial or Intercondylar Portal Failure
- Social security system membership failure
- Refusal of consent of child or parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic intercondylar and posteromedial portalDiagnosis 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. | Procedure or surgery | Arthroscopic intercondylar and posteromedial portal |
Primary outcome
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.
1 secondary outcome
Number of hidden lesions diagnosed during the arthroscopic procedure and not seen in preoperatively MRI.
Time frame: Day 1 (during surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck CHOTEL, Pr principal investigator
Service de Chirurgie Orthopédique Pédiatrique - Hôpital Femme Mère Enfant - 59, Bd Pinel 69677 BRON CEDEX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic intercondylar and posteromedial portal in people with Chronic Knee Instability, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.