Evaluation of the Safety and Efficacy of Meniscal Preservation Surgery

Status unconfirmed

Conditions studied: Meniscal Extrusion

In brief

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.

Key facts

Study ID

NCT05735899

Run by

Andrews Research & Education Foundation

People needed

20

Starts

2022-08-16

Expected to finish

2025-08-16

Last updated by the study team

2024-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Exclusion criteria will include:
• Participants requiring surgery for either anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) reconstruction
• Participants with a history of an autoimmune disease
• Participants with a history of diabetes
• Participants with a history of a blood/clotting disorder
• Participants with a history of previous surgery on the injured knee
• Participants with advanced knee OA or excessive knee malalignment

Where it is running

• Andrews Institute for Orthopaedics & Sports Medicine — Gulf Breeze, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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