Knee InjuriesATMLNCT06313424
Arthroscopic Treatment of Meniscal Lesions on Healthy Meniscus in Children and Adolescents
An observational study of Knee Injuries, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Meniscal lesions are common in pediatrics and mainly affect adolescents. These lesions can jeopardize the functional prognosis of the knee in the short, medium or long term if they are not well managed. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Knee Injuries
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2023to 29 Apr 2024
- Phase
- Observational
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Minor subject (under 18 years old) operated on at Strasbourg University Hospital for repair of lesions on healthy meniscus during the period from February 1, 2010 to September 30, 2022.
Who may be able to join
- Minor subject under 18 years old
- Subject operated on at Strasbourg University Hospital for repair of lesions on healthy meniscus during the period from February 1, 2010 to September 30, 2022.
- Absence of written opposition in the medical file of the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
Who cannot join
- Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
- Subject with lesion on discoid meniscus
- Incomplete or unusable clinical file
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Pédiatrique - CHU de Strasbourg - France
Strasbourg, 67091
Philippe GICQUEL, MD, PhD, 33 3 88 12 82 65, Philippe.Gicquel@chru-strasbourg.fr
Philippe GICQUEL, MD, PhD
About this study
Official title: Arthroscopic Treatment of Meniscal Lesions on Healthy Meniscus in Children and Adolescents: Diagnostic Circumstances, Treatment and Results
Meniscal lesions are common in pediatrics and mainly affect adolescents. These lesions can jeopardize the functional prognosis of the knee in the short, medium or long term if they are not well managed.
More precisely, it is a question of determining whether arthroscopic repair of isolated meniscal lesions in children gives good results and what factors influence them, with the aim of improving the care of children suffering from meniscal lesions.
Read more
The treatment of meniscal lesions comes down to either conservative or restorative treatment or non-conservative treatment by meniscectomy. For most authors, the treatment of meniscal lesions must remain restorative through meniscal suture, leaving no room for meniscectomy. The open approach has given way to the arthroscopic approach which, according to the literature, is the gold standard. Meniscal lesions are varied and therefore there are numerous therapeutic procedures. Therapeutic indications are precise but the results of the treatments remain differently assessed depending on the studies; studies evaluating the results of treatment in the pediatric population are few in number.
Based on this observation, the present study aims to describe the results of repairs of meniscal lesions in pediatric traumatology.
- Conditions
- Knee Injuries
- Keywords
- Knee Injuries, Meniscus, Pediatric traumatology
- Medical subject headings
- Knee Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
description of the results of repairs of meniscal lesions in pediatric traumatology
This study is retrospective
Measured: Files analysed retrospectively from February 1, 2010 to September 30, 2022 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start29 Aug 2023
- Primary completionApr 2024 (estimated)
- Study completion29 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313424
- Sponsor's protocol ID
- 9029
- Acronym
- ATML
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Treatment of Meniscal Lesions on Healthy Meniscus in Children and Adolescents: Diagnostic Circumstances, Treatment and Results
- ClinicalTrials.gov ID
- NCT06313424
- Acronym / sponsor ID
- ATML / 9029
- Conditions
- Knee Injuries
- Keywords
- Knee Injuries, Meniscus, Pediatric traumatology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- 29 Apr 2024 (estimated)
- First posted
- 15 Mar 2024 (actual)
- 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.
Meniscal lesions are common in pediatrics and mainly affect adolescents. These lesions can jeopardize the functional prognosis of the knee in the short, medium or long term if they are not well managed.
More precisely, it is a question of determining whether arthroscopic repair of isolated meniscal lesions in children gives good results and what factors influence them, with the aim of improving the care of children suffering from meniscal lesions.
The treatment of meniscal lesions comes down to either conservative or restorative treatment or non-conservative treatment by meniscectomy. For most authors, the treatment of meniscal lesions must remain restorative through meniscal suture, leaving no room for meniscectomy. The open approach has given way to the arthroscopic approach which, according to the literature, is the gold standard. Meniscal lesions are varied and therefore there are numerous therapeutic procedures. Therapeutic indications are precise but the results of the treatments remain differently assessed depending on the studies; studies evaluating the results of treatment in the pediatric population are few in number.
Based on this observation, the present study aims to describe the results of repairs of meniscal lesions in pediatric traumatology.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Minor subject (under 18 years old) operated on at Strasbourg University Hospital for repair of lesions on healthy meniscus during the period from February 1, 2010 to September 30, 2022.
Key inclusion criteria (3 listed)
- Minor subject under 18 years old
- Subject operated on at Strasbourg University Hospital for repair of lesions on healthy meniscus during the period from February 1, 2010 to September 30, 2022.
- Absence of written opposition in the medical file of the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
Key exclusion criteria (3 listed)
- Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
- Subject with lesion on discoid meniscus
- Incomplete or unusable clinical file
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
description of the results of repairs of meniscal lesions in pediatric traumatology
Time frame: Files analysed retrospectively from February 1, 2010 to September 30, 2022 will be examined
This study is retrospective
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries, run by University Hospital, Strasbourg, France 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe GICQUEL, MD, PhD (33 3 88 12 82 65, Philippe.Gicquel@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of the results of repairs of meniscal lesions in pediatric traumatology (time frame: Files analysed retrospectively from February 1, 2010 to September 30, 2022 will be examined). 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 15 Mar 2024.