Knee ArthroscopySMINCT06098391
Results at More Than 10 Years of Meniscal Sutures Without Avivement
An observational study of Knee Arthroscopy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Currently, suturing the lesion is recommended rather than the classic meniscectomy, which leads to early and subsequent gonarthrosis. The most commonly practiced technique is arthroscopic suturing after avivement the area to be sutured to promote healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroscopy
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2023to 8 Jun 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patient (≥18 years old) having medial or lateral meniscal lesion of the knee treated by arthroscopic suture without avivement with or without reconstruction of the anterior cruciate ligament and operated on at the HUS between January 1, 2011 and June 30, 2013
Who may be able to join
- Adult patient (≥18 years old)
- Gender indifferent
- Patient operated on at the HUS between January 1, 2011 and June 30, 2013
- Medial or lateral meniscal lesion of the knee treated by arthroscopic suture without sharpening with or without reconstruction of the anterior cruciate ligament.
- 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
- Subject having expressed his opposition to the reuse of his data for scientific research purposes.
- Subject under judicial protection
- Subject under guardianship or curatorship
- Meniscal lesion not sutured or sutured with sharpening.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Orthopédie - Traumatologie Membre Supérieur - CHU de Strasbourg - France
Strasbourg, 67091
Jean-Yves JENNY, MD, PhD, 33 3 68 76 51 76, Jean-Yves.JENNY@chru-strasbourg.fr
Jean-Yves JENNY, MD, PhD
About this study
Currently, suturing the lesion is recommended rather than the classic meniscectomy, which leads to early and subsequent gonarthrosis. The most commonly practiced technique is arthroscopic suturing after avivement the area to be sutured to promote healing. But the real benefit of this enhancement has never been documented. The complexity of the surgical procedure makes the acceptability of this indication low by orthopedic surgeons at present (10% sutures compared to 90% meniscectomies).
The aim of the study is to evaluate the 10-year survival rate of meniscal sutures without avivement.
- Conditions
- Knee Arthroscopy
- Keywords
- knee arthroscopy, Meniscal suture, Meniscal lesion, Meniscectomy, Arthroscopic suturing
What is being measured
The primary outcome is the main question the study is designed to answer.
10-year survival rate of meniscal sutures without avivement
Measured: 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start8 Sep 2023
- Primary completionJun 2024 (estimated)
- Study completion8 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroscopyStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 100 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
- NCT06098391
- Sponsor's protocol ID
- 9060
- Acronym
- SMI
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 24 Oct 2023
- 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results at More Than 10 Years of Meniscal Sutures Without Avivement
- ClinicalTrials.gov ID
- NCT06098391
- Acronym / sponsor ID
- SMI / 9060
- Conditions
- Knee Arthroscopy
- Keywords
- knee arthroscopy, Meniscal suture, Meniscal lesion, Meniscectomy, Arthroscopic suturing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- 8 Jun 2024 (estimated)
- First posted
- 24 Oct 2023 (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.
Currently, suturing the lesion is recommended rather than the classic meniscectomy, which leads to early and subsequent gonarthrosis. The most commonly practiced technique is arthroscopic suturing after avivement the area to be sutured to promote healing. But the real benefit of this enhancement has never been documented. The complexity of the surgical procedure makes the acceptability of this indication low by orthopedic surgeons at present (10% sutures compared to 90% meniscectomies).
The aim of the study is to evaluate the 10-year survival rate of meniscal sutures without avivement.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years old) having medial or lateral meniscal lesion of the knee treated by arthroscopic suture without avivement with or without reconstruction of the anterior cruciate ligament and operated on at the HUS between January 1, 2011 and June 30, 2013
Key inclusion criteria (5 listed)
- Adult patient (≥18 years old)
- Gender indifferent
- Patient operated on at the HUS between January 1, 2011 and June 30, 2013
- Medial or lateral meniscal lesion of the knee treated by arthroscopic suture without sharpening with or without reconstruction of the anterior cruciate ligament.
- 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 (4 listed)
- Subject having expressed his opposition to the reuse of his data for scientific research purposes.
- Subject under judicial protection
- Subject under guardianship or curatorship
- Meniscal lesion not sutured or sutured with sharpening.
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
10-year survival rate of meniscal sutures without avivement
Time frame: 10 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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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 Arthroscopy, 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 5 inclusion and 4 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 24 Oct 2023. 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 Jean-Yves JENNY Jean, MD, PhD (33 3 68 76 51 76, 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?
10-year survival rate of meniscal sutures without avivement (time frame: 10 years after 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 24 Oct 2023.