ClinicalTrials.gg
RecruitingNCT05735899Updated Feb 21, 2024

Evaluation of the Safety and Efficacy of Meniscal Preservation Surgery

An observational study in Meniscal Extrusion, sponsored by Andrews Research & Education Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-21.

Sponsored by Andrews Research & Education Foundation · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Aug 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

Treatment for meniscal extrusion varies on a patient-by-patient basis as it is generally dependent on the underlying cause of the extrusion. Extrusion should be detected early and treated appropriately. If left untreated irreversible loss of articular cartilage can ensue leading ultimately to osteoarthritis (OA). Meniscal extrusion is not commonly seen in isolation, but rather in association with meniscal tears or OA. Statistically speaking, the most common meniscal pathology associated with extrusion is posterior horn tearing. The goal of surgery with these two diagnoses is to debride and repair the root tear but also to correct the extrusion. Ignoring the extrusion while only fixing the root tear will increases the patient's chances of developing OA in the future. Surgeries repairing larger tears such as radial tears should also look to correct the noted extrusion and restore overall function for long-term patient meniscal health. The primary operative means of treatment for meniscal extrusion relies on centralization of the extruded meniscus. Centralization refers to the restoration of the meniscus to its native position on the tibial plateau. Ozeki et al. looked to accomplish centralization of extruded medial menisci via the pull-out suture technique. Koga et al noted significant positive outcomes in a prospective study on patients undergoing lateral meniscal centralization. This technique involved placing suture anchors on the edge of the tibial plateau with suture loops passing through the meniscocapsular junction. After the anchor knots were placed, the body of the meniscus was then centralized and stabilized in its anatomic position thereby restoring proper meniscal function. Surgical techniques for the treatment of meniscal extrusion continue to advance and represent areas of future investigation.

As previously mentioned, meniscal injury and meniscal extrusion are prevalent amongst middle-aged and elderly people and represent one of the most important risk factors for the development of OA. After failing conservative treatment options, knee replacement is the surgical intervention utilized by orthopaedic surgeons to treat pain and loss of function associated with OA. According to data published by Blue Cross Blue Shield, the average cost associated with an inpatient total knee replacement (TKR) is $30,249. With estimates that 3.5 million TKR surgeries will be performed annually in the United States by 2040, healthcare costs associated with OA are likely to continue to rise without the development of new treatment methods.

Advances in the treatment of previously irreparable meniscal injuries and the identification of meniscal pathology provide potential measures to delay the onset of OA. Reduction in the prevalence of OA will lead to decreased annual spending on healthcare costs associated with OA and TKR. Reduction in the prevalence of OA will also improve productivity in the workforce as well as keeping non workers active in enjoying the many outdoor recreational activities in the state of Florida. Thus, the aim of this study is to evaluate the long-term safety and efficacy of patients undergoing surgical meniscal preservation to correct meniscal extrusion.

02

Conditions studied

  • Meniscal Extrusion
03

In context

Lead sponsor

Andrews Research & Education Foundation is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Andrews Institute physicians' practices

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 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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 weeks post-op timepoint

  2. 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

    Time frame: 6 months post-op timepoint

  3. 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

    Time frame: 12 months post-op timepoint

  4. 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.

    Time frame: 6 weeks post-op timepoint

  5. 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.

    Time frame: 6 months post-op timepoint

  6. 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.

    Time frame: 12 months post-op timepoint

07

Study locations

1 of 1 sites recruiting
  • Andrews Institute for Orthopaedics & Sports Medicine
    Gulf Breeze, Florida 32561, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2022 (actual). Primary completion is estimated for Aug 2025, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2023
First posted
Feb 21, 2023
StartActual
Aug 16, 2022
Primary completionEst.
Aug 16, 2025
CompletionEst.
Aug 16, 2025
Last update
Feb 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05735899
Lead sponsor
Andrews Research & Education Foundation
Collaborators
Florida
Responsible party
Sponsor
First posted
Feb 21, 2023
Start date
Aug 16, 2022
Primary completion
Aug 16, 2025 (estimated)
Completion
Aug 16, 2025 (estimated)
Last update
Feb 21, 2024

Study contacts

Jessica Truett, BCBA
Contact
Jessica.Truett@andrewsref.org
8509168570

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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