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NCT05735899
Evaluation of the Safety and Efficacy of Meniscal Preservation Surgery
Conditions: Meniscal Extrusion
Sex: All
Ages: 18 Years – N/A
Enrollment: 20
Sponsor: Andrews Research & Education Foundation
Location: United States
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.
Eligibility Criteria
Inclusion Criteria Patients 18 years or older who are scheduled to have arthroscopic knee surgery to correct meniscal extrusion and preserve the meniscus by one of the investigating physicians will be screened for participation in this study.Exclusion CriteriaExclusion criteria will include:Participants requiring surgery for either anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) reconstructionParticipants with a history of an autoimmune diseaseParticipants with a history of diabetesParticipants with a history of a blood/clotting disorderParticipants with a history of previous surgery on the injured kneeParticipants with advanced knee OA or excessive knee malalignment
Source: ClinicalTrials.gov (NCT05735899). StuddyBuddy aggregates publicly available trial information.