NCT05735899

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2025

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

January 30, 2023

Last Update Submit

February 19, 2024

Conditions

Meniscal Extrusion

Outcome Measures

Primary Outcomes (6)

  • Patient Reported Outcomes Measurement Information System (PROMIS-Pain and Functioning Questionnaire)

    PROMIS Pain and Functioning Questionnaire used in this study to to assess overall health functioning and rehabilitation levels of each participant

    6 weeks post-op timepoint

  • Patient Reported Outcomes Measurement Information System (PROMIS-Pain and Functioning Questionnaire)

    PROMIS Pain and Functioning Questionnaire used in this study to to assess overall health functioning and rehabilitation levels of each participant

    6 months post-op timepoint

  • Patient Reported Outcomes Measurement Information System (PROMIS-Pain and Functioning Questionnaire)

    PROMIS Pain and Functioning Questionnaire used in this study to to assess overall health functioning and rehabilitation levels of each participant

    12 months post-op timepoint

  • Ultrasound

    US is a non-invasive and cost-effective imaging modality that allows the physician to assess anatomic structures of the knee such as the meniscus. The meniscotibbital ligament lesion(MTLL) will be measured using ultrasound.

    6 weeks post-op timepoint

  • Ultrasound

    US is a non-invasive and cost-effective imaging modality that allows the physician to assess anatomic structures of the knee such as the meniscus. The meniscotibbital ligament lesion(MTLL) will be measured using ultrasound.

    6 months post-op timepoint

  • Ultrasound

    US is a non-invasive and cost-effective imaging modality that allows the physician to assess anatomic structures of the knee such as the meniscus. The meniscotibbital ligament lesion(MTLL) will be measured using ultrasound.

    12 months post-op timepoint

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Andrews Institute physicians' practices

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrews Institute for Orthopaedics & Sports Medicine

Gulf Breeze, Florida, 32561, United States

RECRUITING

Central Study Contacts

Jessica Truett, BCBA

CONTACT

8509168570Jessica.Truett@andrewsref.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 21, 2023

Study Start

August 16, 2022

Primary Completion

August 16, 2025

Study Completion

August 16, 2025

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations

US(1)