Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial meniscectomy using the Arthrex Nanoscope | Experimental |
| |
| Partial meniscectomy using conventional arthroscopy equipment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthrex Nanoscope | Device | Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Operative Visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis outcome Score (KOOS) | 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 | Pre Operative, 2 weeks and 6 weeks post op |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolie I Caraci, BA | Contact | 18009337001 | caroline.caraci@arthrex.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Rhode Island | Warwick | Rhode Island | 02886 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional Arthroscopy without Arthrex Nanoscope | Device | partial meniscectomy using conventional arthroscopy |
|
| 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 | Pre Operative, 2 weeks 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 |
| PROMIS Physical Function 13a scale | preop, 2 weeks post op, and 6 weeks post op |