Wrist Arthropathy Clinical Trial
Official title:
A Comparative Study Evaluating the Diagnostic Accuracy of Wrist Arthroscopy Using the NanoScope Compared to Conventional Arthroscopic Instrumentation
Verified date | October 2023 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 22, 2023 |
Est. primary completion date | March 22, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age > 18 years. 2. Wrist pathology based on clinical examination/imaging studies undergoing wrist arthroscopy for further evaluation/treatment. 3. Willingness to participate in the study Exclusion Criteria: - 1. Age < 18 years. |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope | Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent. | Day 1 | |
Primary | Surgeon-Rated Radiocarpal Visualization With Conventional Instrument | Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent. | Day 1 | |
Primary | Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope | Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent. | Day 1 | |
Primary | Surgeon-Rated Midcarpal Visualization With Conventional Instrument | Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent. | Day 1 | |
Secondary | Surgeon-rated Ease of Use of Arthrex NanoScope | Ease of use will be rated on a 5-point scale: (1) - very difficult; (2) - difficult; (3) - neutral; (4) - easy; (5) - very easy. | Day 1 | |
Secondary | Surgeon-rated Ease of Use of Conventional Instrument | Ease of use will be rated on a 5-point scale: (1) - very difficult; (2) - difficult; (3) - neutral; (4) - easy; (5) - very easy. | Day 1 | |
Secondary | Surgeon-rated Confidence in Arthrex NanoScope Diagnosis | Confidence will be rated on a 5-point scale: (1) - not at all confident; (2) - not very confident; (3) - neutral; (4) - fairly confident; (5) - very confident. | Day 1 | |
Secondary | Surgeon-rated Confidence in Conventional Instrument Diagnosis | Confidence will be rated on a 5-point scale: (1) - not at all confident; (2) - not very confident; (3) - neutral; (4) - fairly confident; (5) - very confident. | Day 1 |
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