Recruiting

Meniscal Preservation Surgery

Sponsor:

Andrews Research & Education Foundation

Code:

NCT05735899

Conditions

Meniscal Extrusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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

Study ID

NCT05735899

Start date

Aug 16, 2022

Status verified date

Feb, 2024

Completion date

Aug 16, 2025

Anticipated

Primary completion date

Aug 16, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Criteria

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Core Treatment Group

This is the only group in this study. Participants will receive full standard of care meniscal repair, followed by assessment interventions- ultrasound, MRI, and physical assessment to document healing progress. Participants will return for standard of care post-operative visits with the physician- 6 weeks, 6 months, and 1 year after the operation is performed- at which point the aforementioned interventions will be completed.

Primary outcome measure

  • Patient Reported Outcomes Measurement Information System (PROMIS-Pain and Functioning Questionnaire) [ Time Frame: 6 weeks post-op timepoint ]
  • Patient Reported Outcomes Measurement Information System (PROMIS-Pain and Functioning Questionnaire) [ Time Frame: 6 months post-op timepoint ]
  • Patient Reported Outcomes Measurement Information System (PROMIS-Pain and Functioning Questionnaire) [ Time Frame: 12 months post-op timepoint ]
  • Ultrasound [ Time Frame: 6 weeks post-op timepoint ]
  • Ultrasound [ Time Frame: 6 months post-op timepoint ]
  • Ultrasound [ Time Frame: 12 months post-op timepoint ]

Central Contacts and Locations

Central contacts

Jessica Truett, BCBA

8509168570Jessica.Truett@andrewsref.org

Locations

Andrews Institute for Orthopaedics & Sports Medicine

Recruiting

Gulf Breeze, Florida, United States, 32561

Contacts

Jessi Truett, MA

850-916-8570jessica.truett@andrewsref.org

Principal Investigator:

Steve Jordan, MD

More Information

Sponsor

Andrews Research & Education Foundation

Last update posted

Feb 21, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrews Research & Education Foundation on 2024-02-21.