Meniscal Tear
Conditions
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
Interventions
DEVICEArthrex Nanoscope
Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions
DEVICEConventional Arthroscopy without Arthrex Nanoscope
partial meniscectomy using conventional arthroscopy
Sponsors
Arthrex, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject requires simple partial posterior or mid-body meniscectomy. 2. Subject is 18 - 60 years of age. 3. Subject body mass index (BMI) is 35 or lower (BMI ≤ 35). 4. Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits. 5. Confirmed meniscal injury by physical exam as per standard of care. 6. Normal mechanical alignment; \< 5° varus and \< 7° valgus, of the affected knee by clinical assessment or X-Rays as per standard of care
Exclusion criteria
1. Subject requires complex repair or anterior meniscectomy. 2. Subject has a concomitant chondral lesion of the ipsilateral knee in addition to meniscal tear. 3. Current bilateral knee injury. 4. Insufficient quantity or quality of bone. 5. Blood supply limitations and previous infections which may retard healing. 6. Congenital ligamentous hypermobility defined by Beighton score 4 or 5. 7. Locked knee or haemarthrosis. 8. Subjects that are skeletally immature. 9. Advanced Osteoarthritis; Kellgren Lawrence ≥ 2 10. Fracture of the lower extremities within 6 months prior to screening. 11. Previous surgery on the affected knee within 12 months prior to screening. 12. Sensitivity to silicone, polyester, nylon, FD&C Blue No. 2 dye and beeswax. 13. Other concomitant disease that would interfere with study outcomes. 14. Subject is included in a vulnerable population (child, prisoner, etc). 15. 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. 16. Subject is requesting or receiving Worker's compensation related to the knee injury. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost Comparison (TDBC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC) Score | Pre Operative, 2 weeks and 6 weeks post op | 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. |
| Visual Analogue Scale (VAS) | Pre Operative, 2 weeks and 6 weeks post op | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis outcome Score (KOOS) | Pre Operative, 2 weeks and 6 weeks post op | KOOS is a five-subscale patient-reported instrument intended for use from the time of knee injury to the development of osteoarthritis. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures |
| PROMIS Physical Function 13a scale | preop, 2 weeks post op, and 6 weeks post op | — |
| PROMIS Pain Interference 6a scale | preop, 2 weeks post op, and 6 weeks post op | — |
| PROMIS Pain Intensity 3a scale | preop, 2 weeks post op, and 6 weeks post op | — |
Countries
United States
Contacts
Primary ContactCarolie I Caraci, BA
Outcome results
None listed