Meniscal TearNCT06603740
Nanoscope Cost Analysis Study
A study testing Arthrex Nanoscope and Conventional Arthroscopy without Arthrex Nanoscope in people with Meniscal Tear, run by Arthrex, Inc. at 1 site in United States.
Trial summary
The study is a pilot study designed to generate preliminary data regarding the cost of partial meniscectomy using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniscal Tear
- What is being tested?
- Arthrex Nanoscope and Conventional Arthroscopy without Arthrex Nanoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2024to Jul 2025
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject requires simple partial posterior or mid-body meniscectomy.
- Subject is 18 - 60 years of age.
- Subject body mass index (BMI) is 35 or lower (BMI ≤ 35).
- Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
- Confirmed meniscal injury by physical exam as per standard of care.
- Normal mechanical alignment; < 5° varus and < 7° valgus, of the affected knee by clinical assessment or X-Rays as per standard of care
Who cannot join
- Subject requires complex repair or anterior meniscectomy.
- Subject has a concomitant chondral lesion of the ipsilateral knee in addition to meniscal tear.
- Current bilateral knee injury.
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections which may retard healing.
- Congenital ligamentous hypermobility defined by Beighton score 4 or 5.
Show all 16Show fewer
- Locked knee or haemarthrosis.
- Subjects that are skeletally immature.
- Advanced Osteoarthritis; Kellgren Lawrence ≥ 2
- Fracture of the lower extremities within 6 months prior to screening.
- Previous surgery on the affected knee within 12 months prior to screening.
- Sensitivity to silicone, polyester, nylon, FD\&C Blue No. 2 dye and beeswax.
- Other concomitant disease that would interfere with study outcomes.
- Subject is included in a vulnerable population (child, prisoner, etc).
- Conditions that tend to limit the patient's ability or willingness to restrict activities, follow directions, or perform online subject assessments during the healing period.
- Subject is requesting or receiving Worker's compensation related to the knee injury. -
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopedic Rhode Island
Warwick, Rhode Island, 02886
Jennifer Stedman, 401-777-7000
Michael Bradley, MD
About this study
Official title: Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee Meniscectomy Versus Conventional Arthroscopy
The study is a pilot study designed to generate preliminary data regarding the cost of partial meniscectomy using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting
- Conditions
- Meniscal Tear
- Being tested
- Arthrex Nanoscope, Conventional Arthroscopy without Arthrex Nanoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrex NanoscopeDevice
Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions
Conventional Arthroscopy without Arthrex NanoscopeDevice
partial meniscectomy using conventional arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| Partial meniscectomy using the Arthrex Nanoscope | Experimental | Not described Receives: Device: Arthrex Nanoscope |
| Partial meniscectomy using conventional arthroscopy equipment | Other | Not described Receives: Device: Conventional Arthroscopy without Arthrex Nanoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost Comparison (TDBC)
Cost comparison using the time-drive activity-based costing (TDABC) study design between NanoScope versus conventional arthroscopy for partial meniscectomy in a traditional OR setting.
Measured: Operative Visit
Secondary outcomes (2)
International Knee Documentation Committee (IKDC) Score
The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee.
The questions prompt an answer 0-10.
The total score is interpreted as a measure of function with higher scores representing higher levels of function.
Measured: Pre Operative, 2 weeks and 6 weeks post op
Visual Analogue Scale (VAS)
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.v
Measured: Pre Operative, 2 weeks and 6 weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startNov 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscal 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603740
- Sponsor's protocol ID
- AIRR-0211
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee Meniscectomy Versus Conventional Arthroscopy
- ClinicalTrials.gov ID
- NCT06603740
- Acronym / sponsor ID
- AIRR-0211
- Conditions
- Meniscal Tear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Sep 2024 (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 study is a pilot study designed to generate preliminary data regarding the cost of partial meniscectomy using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial meniscectomy using the Arthrex Nanoscope | Experimental | Device: Arthrex Nanoscope |
| Partial meniscectomy using conventional arthroscopy equipment | Other | Device: Conventional Arthroscopy without Arthrex Nanoscope |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject requires simple partial posterior or mid-body meniscectomy.
- Subject is 18 - 60 years of age.
- Subject body mass index (BMI) is 35 or lower (BMI ≤ 35).
- Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
- Confirmed meniscal injury by physical exam as per standard of care.
Key exclusion criteria (16 listed)
- Subject requires complex repair or anterior meniscectomy.
- Subject has a concomitant chondral lesion of the ipsilateral knee in addition to meniscal tear.
- Current bilateral knee injury.
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections which may retard healing.
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 |
|---|---|---|
| Arthrex NanoscopeArthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions | Device | Partial meniscectomy using the Arthrex Nanoscope |
| Conventional Arthroscopy without Arthrex Nanoscopepartial meniscectomy using conventional arthroscopy | Device | Partial meniscectomy using conventional arthroscopy equipment |
Primary outcome
Cost Comparison (TDBC)
Time frame: Operative Visit
Cost comparison using the time-drive activity-based costing (TDABC) study design between NanoScope versus conventional arthroscopy for partial meniscectomy in a traditional OR setting.
2 secondary outcomes
International Knee Documentation Committee (IKDC) Score
Time frame: Pre Operative, 2 weeks and 6 weeks post op
Visual Analogue Scale (VAS)
Time frame: Pre Operative, 2 weeks and 6 weeks post op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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?
A study testing Arthrex Nanoscope and Conventional Arthroscopy without Arthrex Nanoscope in people with Meniscal Tear, run by Arthrex, Inc. 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 6 inclusion and 16 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 19 Sep 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 Carolie I Caraci, BA (18009337001, caroline.caraci@arthrex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost Comparison (TDBC) (time frame: Operative Visit). 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 19 Sep 2024.