Meniscal ExtrusionNCT05735899
Evaluation of the Safety and Efficacy of Meniscal Preservation Surgery
An observational study of Meniscal Extrusion, run by Andrews Research & Education Foundation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscal Extrusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 16 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Andrews Institute physicians' practices
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Andrews Institute for Orthopaedics & Sports Medicine
Gulf Breeze, Florida, 32561
Jessi Truett, MA, 850-916-8570, jessica.truett@andrewsref.org
Steve Jordan, MD
About this study
Official title: Evaluation of the Safety and Efficacy of Meniscal Preservation Surgery to Correct Meniscal Extrusion
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.
- Conditions
- Meniscal Extrusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post-op timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start16 Aug 2022
- Primary completion16 Aug 2025 (estimated)
- Study completion16 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscal ExtrusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrews Research & Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735899
- Sponsor's protocol ID
- Meniscal Extrusion
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Meniscal Preservation Surgery to Correct Meniscal Extrusion
- ClinicalTrials.gov ID
- NCT05735899
- Acronym / sponsor ID
- Meniscal Extrusion
- Conditions
- Meniscal Extrusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Andrews Research & Education FoundationUniversity, hospital or other
- Collaborators
- Florida
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 16 Aug 2025 (estimated)
- Study completion
- 16 Aug 2025 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Andrews Institute physicians' practices
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Reported Outcomes Measurement Information System (PROMIS-Pain and Functioning Questionnaire)
Time frame: 6 weeks post-op timepoint
PROMIS Pain and Functioning Questionnaire used in this study to to assess overall health functioning and rehabilitation levels of each participant
Patient Reported Outcomes Measurement Information System (PROMIS-Pain and Functioning Questionnaire)
Time frame: 6 months post-op timepoint
PROMIS Pain and Functioning Questionnaire used in this study to to assess overall health functioning and rehabilitation levels of each participant
Patient Reported Outcomes Measurement Information System (PROMIS-Pain and Functioning Questionnaire)
Time frame: 12 months post-op timepoint
PROMIS Pain and Functioning Questionnaire used in this study to to assess overall health functioning and rehabilitation levels of each participant
Ultrasound
Time frame: 6 weeks post-op timepoint
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.
Ultrasound
Time frame: 6 months post-op timepoint
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.
Ultrasound
Time frame: 12 months post-op timepoint
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Enrolling by invitation
The Effect of Centralization on Medial Meniscal Extrusion for Medial Meniscus Posterior Root Tear Repair
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Recruiting
Transtibial Pull Out Method Versus Suture Anchor Method for Meniscus Extrusion
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RecruitingPhase 4
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscal Extrusion, run by Andrews Research & Education Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Truett, BCBA (8509168570, Jessica.Truett@andrewsref.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcomes Measurement Information System (PROMIS-Pain and Functioning Questionnaire) (time frame: 6 weeks post-op timepoint). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.