Meniscus TearNCT05617807
Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy
A study testing Nanoscopic partial meniscectomy and Standard Partial Meniscectomy in people with Meniscus Tear, run by Marshall University at 2 sites in United States.
Trial summary
Standard arthroscopy has been the gold standard for treatment of meniscus tears since the 1980's. The purpose of this study is to analyze the clinical outcomes of using the smaller diameter Nanoscope for partial menisectomy. Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniscus Tear
- What is being tested?
- Nanoscopic partial meniscectomy and Standard Partial Meniscectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2022to Dec 2024
- Phase
- Interventional
- 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 Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- MRI positive for meniscus tear
- More than 3mm of joint space on PA flexion weightbearing x rays
- Primary arthroscopy
Who cannot join
- Workers compensation
- Older than 60 years of age
- Revision surgeries
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
Marshall Orthopaedics - Teays Valley
Scott Depot, West Virginia, 25560
Chad Lavender, 304-552-6514, doclav@gmail.com
Chad Lavender, MD
- Active, not recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Standard arthroscopy has been the gold standard for treatment of meniscus tears since the 1980's. The purpose of this study is to analyze the clinical outcomes of using the smaller diameter Nanoscope for partial menisectomy. The authors hypothesize that the Nanoscopic partial menisectomy patients will have less pain and return function faster than standard arthroscopy.
- Conditions
- Meniscus Tear
- Being tested
- Nanoscopic partial meniscectomy, Standard Partial Meniscectomy
- Keywords
- Arthroscopy, Meniscus, Meniscectomy, Nanoscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanoscopic partial meniscectomyProcedure or surgery
Patients will have a partial meniscectomy performed using the arthrex nanoscope and it will be compared to partial meniscectomy performed using standard arthroscopic equipment
Standard Partial MeniscectomyProcedure or surgery
Patients will have partial meniscectomy performed using standard arthroscopic equipment
| Study group | Role | What they receive |
|---|---|---|
| Nanoscopic Partial Meniscectomy | Experimental | This is the experimental group. patients will have a partial meniscectomy performed using the arthrex nanoscope Receives: Procedure: Nanoscopic partial meniscectomy |
| Standard Partial Meniscectomy | Active comparator | Patients will have a partial meniscectomy performed using standard arthroscopic equipment which is the current gold standard Receives: Procedure: Standard Partial Meniscectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcomes following partial meniscectomy: Knee Injury and Osteoarthritis Score
We will be looking at functional outcomes following partial meniscectomy with the nanoscope compared to standard arthroscopy by looking at Knee Injury and Osteoarthritis Score (O -100 with higher being patients doing better functionally)
Measured: 6 weeks
Functional Outcomes Following Partial Meniscectomy: International Knee Documentation Committee Score
We will be looking at functional outcomes following partial meniscectomy with the nanoscope compared to standard arthroscopy by looking at the International Knee Documentation Committee Score (0-100 with higher being patients doing better functionally)
Measured: 6 weeks
Secondary outcomes (3)
Pain: Visual Analog Pain Score
Pain following partial meniscectomy with the nanoscope compared to standard arthroscopy using Visual Analog Pain Score (0-10 with 0 being no pain and 10 being the worst pain)
Measured: 6 weeks
Narcotic Medication Use
we will be looking at the amount of narcotic pain medication used following nanoscopic partial meniscectomy compared to standard arthroscopy
Measured: 24 hours
Return to work
time to return to work following partial meniscectomy
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Dec 2022
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc., Medstar Health Research Institute
- Responsible party
- Principal investigator, Shane Taylor, Marshall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617807
- Sponsor's protocol ID
- 1926751-2
- Status last verified
- Mar 2024
- First submitted
- 7 Nov 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy
- ClinicalTrials.gov ID
- NCT05617807
- Acronym / sponsor ID
- 1926751-2
- Conditions
- Meniscus Tear
- Keywords
- Arthroscopy, Meniscus, Meniscectomy, Nanoscopic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Collaborators
- Arthrex, Inc., Medstar Health Research Institute
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Nov 2022 (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.
Standard arthroscopy has been the gold standard for treatment of meniscus tears since the 1980's. The purpose of this study is to analyze the clinical outcomes of using the smaller diameter Nanoscope for partial menisectomy. The authors hypothesize that the Nanoscopic partial menisectomy patients will have less pain and return function faster than standard arthroscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Nanoscopic Partial Meniscectomy | Experimental | Procedure: Nanoscopic partial meniscectomyThis is the experimental group. patients will have a partial meniscectomy performed using the arthrex nanoscope |
| Standard Partial Meniscectomy | Active comparator | Procedure: Standard Partial MeniscectomyPatients will have a partial meniscectomy performed using standard arthroscopic equipment which is the current gold standard |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- MRI positive for meniscus tear
- More than 3mm of joint space on PA flexion weightbearing x rays
- Primary arthroscopy
Key exclusion criteria (3 listed)
- Workers compensation
- Older than 60 years of age
- Revision surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanoscopic partial meniscectomyPatients will have a partial meniscectomy performed using the arthrex nanoscope and it will be compared to partial meniscectomy performed using standard arthroscopic equipment | Procedure or surgery | Nanoscopic Partial Meniscectomy |
| Standard Partial MeniscectomyPatients will have partial meniscectomy performed using standard arthroscopic equipment | Procedure or surgery | Standard Partial Meniscectomy |
Primary outcome
Functional Outcomes following partial meniscectomy: Knee Injury and Osteoarthritis Score
Time frame: 6 weeks
We will be looking at functional outcomes following partial meniscectomy with the nanoscope compared to standard arthroscopy by looking at Knee Injury and Osteoarthritis Score (O -100 with higher being patients doing better functionally)
Functional Outcomes Following Partial Meniscectomy: International Knee Documentation Committee Score
Time frame: 6 weeks
We will be looking at functional outcomes following partial meniscectomy with the nanoscope compared to standard arthroscopy by looking at the International Knee Documentation Committee Score (0-100 with higher being patients doing better functionally)
3 secondary outcomes
Pain: Visual Analog Pain Score
Time frame: 6 weeks
Narcotic Medication Use
Time frame: 24 hours
Return to work
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Meniscus Tear
Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Novel Bioactive Sleeve on Pain and PROMs
Meniscus Tear
Active, not recruitingPhase 3
Dronabinol After Arthroscopic Surgery
Knee Osteoarthritis, Knee Injuries
Not yet recruiting
Needle Arthroscopy vs Conventional Arthroscopy in Knees
Meniscectomy, Meniscal Tears
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanoscopic partial meniscectomy and Standard Partial Meniscectomy in people with Meniscus Tear, run by Marshall University at 2 sites 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 3 inclusion and 3 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Shane Taylor (6094729212, taylorsh@marshall.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcomes following partial meniscectomy: Knee Injury and Osteoarthritis Score (time frame: 6 weeks). The study lists 2 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 20 Mar 2024.