Meniscus LesionNCT02650908
Is Abrasion of the Suture Area Essential for Healing of a Meniscus Lesion?
An observational study of Meniscus Lesion, run by University Hospital, Strasbourg, France.
Trial summary
The most common technique involves a suture meniscus avivement with a rasp or a motorized cutter the suture zone before actual implementation of the suture. But the imperative nature of this avivement is based only on theoretical considerations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscus Lesion
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent meniscal suturing with or without avivement
Who may be able to join
- Patients over 18 years
- Patients who underwent meniscal suturing with or without avivement
Who cannot join
- Patients under 18 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does the Avivement of Suturing Area is Essential for Healing a Meniscus Lesion ?
The most common technique involves a suture meniscus avivement with a rasp or a motorized cutter the suture zone before actual implementation of the suture. But the imperative nature of this avivement is based only on theoretical considerations. The team has an old experience in conducting meniscus sutures without avivement. It therefore seems interesting to compare results with those of literature
- Conditions
- Meniscus Lesion
- Keywords
- Lesion, Meniscus, Avivement, Suturing area
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing meniscus suturing area
Measured: For the duration of hospital stay, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus LesionStudies 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
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Yves JENNY, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650908
- Sponsor's protocol ID
- 6295
- Status last verified
- Jan 2016
- First submitted
- 4 Jan 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Avivement of Suturing Area is Essential for Healing a Meniscus Lesion ?
- ClinicalTrials.gov ID
- NCT02650908
- Acronym / sponsor ID
- 6295
- Conditions
- Meniscus Lesion
- Keywords
- Lesion, Meniscus, Avivement, Suturing area
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 8 Jan 2016 (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.
The most common technique involves a suture meniscus avivement with a rasp or a motorized cutter the suture zone before actual implementation of the suture. But the imperative nature of this avivement is based only on theoretical considerations. The team has an old experience in conducting meniscus sutures without avivement. It therefore seems interesting to compare results with those of literature
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent meniscal suturing with or without avivement
Key inclusion criteria (2 listed)
- Patients over 18 years
- Patients who underwent meniscal suturing with or without avivement
Key exclusion criteria (1 listed)
- Patients under 18 years
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
Healing meniscus suturing area
Time frame: For the duration of hospital stay, up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 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.
Jean-Yves JENNY, MD principal investigator
University Hospital, Strasbourg, France
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Lesion, run by University Hospital, Strasbourg, 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 2 inclusion and 1 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 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Jean-Yves JENNY, MD (33.3.88.55.21.45, jean-yves.jenny@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing meniscus suturing area (time frame: For the duration of hospital stay, up to 1 year). 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 17 Jun 2016.