Nanoscope Cost Analysis Study
ConditionMeniscal Tear
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorArthrex, Inc.
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Arthrex Nanoscope
DeviceArthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions
Conventional Arthroscopy without Arthrex Nanoscope
Devicepartial meniscectomy using conventional arthroscopy
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Partial meniscectomy using the Arthrex NanoscopeExperimental treatment 1 intervention
Group B: Partial meniscectomy using conventional arthroscopy equipmentOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Operative VisitSecondary outcomes
1
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.
Time frame
Pre Operative, 2 weeks and 6 weeks post op2
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
Time frame
Pre Operative, 2 weeks and 6 weeks post opOther outcomes
1
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
Time frame
Pre Operative, 2 weeks and 6 weeks post op2
PROMIS Pain Interference 6a scale
Time frame
preop, 2 weeks post op, and 6 weeks post op3
PROMIS Pain Intensity 3a scale
Time frame
preop, 2 weeks post op, and 6 weeks post op4
PROMIS Physical Function 13a scale
Time frame
preop, 2 weeks post op, and 6 weeks post opSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: