Results at More Than 10 Years of Meniscal Sutures Without Avivement (SMI)

October 18, 2023 updated by: University Hospital, Strasbourg, France

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'Orthopédie - Traumatologie Membre Supérieur - CHU de Strasbourg - France
        • Principal Investigator:
          • Jean-Yves JENNY, MD, PhD
        • Sub-Investigator:
          • Erik SAULEAU, Statistician
        • Contact:
        • Sub-Investigator:
          • Ceyran HAMOUDI, MD
        • Sub-Investigator:
          • Pierre-Antoine DEBORDE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
10-year survival rate of meniscal sutures without avivement
Time Frame: 10 years after surgery
10 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 8, 2024

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9060

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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