Status:
NOT_YET_RECRUITING
Nanoscope Cost Analysis Study
Lead Sponsor:
Arthrex, Inc.
Conditions:
Meniscal Tear
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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. -
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06603740
Start Date
November 1 2024
End Date
July 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
Orthopedic Rhode Island
Warwick, Rhode Island, United States, 02886