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Evaluation of the Safety and Efficacy of Meniscal Preservation Surgery

NCT05735899 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-02-21

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate the safety and efficacy of surgical meniscal preservation techniques to correct meniscal extrusion. The primary endpoint for safety will be analysis of the total number and types of adverse events (AEs) and serious adverse events (SAEs). The primary endpoint for efficacy will include analysis of patient report outcome measures (PROMs).

H0 - Participants undergoing surgical meniscal preservation to correct meniscal extrusion will not exhibit a limited number of safety events nor have favorable outcomes.

H1- Participants undergoing surgical meniscal preservation to correct meniscal extrusion will exhibit a limited number of safety events and have favorable outcomes.

Conditions

  • Meniscal Extrusion

Sponsors & Collaborators

  • Florida

    collaborator OTHER

  • Andrews Research & Education Foundation

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2025-08-16
Completion
2025-08-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05735899 on ClinicalTrials.gov