A Comparative Study Evaluating the Diagnostic Accuracy of Wrist Arthroscopy Using the NanoScope Compared to Conventional Arthroscopic Instrumentation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope
Study Overview
Brief Summary
The purpose of this study is to evaluate the diagnostic efficacy of Arthrex NanoScope compared to conventional arthroscopic instruments. Patients with wrist pathology who are indicated for an arthroscopic procedure will be enrolled pre-operatively after a thorough discussion of the study aims, risks, and benefits. At the time of surgery, under standard conditions, using standard wrist arthroscopy portals, a diagnostic arthroscopy will be performed with the Arthrex Nanoscope. The diagnostic arthroscopy will be performed in a stepwise manner for consistency with notation of pathology and intended intervention. The diagnostic arthroscopy will then be performed with the standard arthroscopic equipment, again noting pathology and final intervention. Post-operatively, diagnostic accuracy, incidence of change in intervention, and surgeon rated ease of use and confidence will be determined.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years.
- •Wrist pathology based on clinical examination/imaging studies undergoing wrist arthroscopy for further evaluation/treatment.
- •Willingness to participate in the study
Exclusion Criteria
- •Age < 18 years.
Outcomes
Primary Outcomes
Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope
Time Frame: Day 1
Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
Surgeon-Rated Radiocarpal Visualization With Conventional Instrument
Time Frame: Day 1
Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope
Time Frame: Day 1
Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
Surgeon-Rated Midcarpal Visualization With Conventional Instrument
Time Frame: Day 1
Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
Secondary Outcomes
- Surgeon-rated Ease of Use of Arthrex NanoScope(Day 1)
- Surgeon-rated Ease of Use of Conventional Instrument(Day 1)
- Surgeon-rated Confidence in Arthrex NanoScope Diagnosis(Day 1)
- Surgeon-rated Confidence in Conventional Instrument Diagnosis(Day 1)