Wrist Arthroscopy Study

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Study Evaluating the Diagnostic Accuracy of Wrist Arthroscopy Using the NanoScope Compared to Conventional Arthroscopic Instrumentation

Conditions
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Wrist Arthropathy

Intervention / Treatment
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* Diagnostic Test: Diagnostic Arthroscopy using the Arthrex NanoScope
* Diagnostic Test: Diagnostic Arthroscopy using standard arthroscopic instruments


Participation Criteria
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Eligibility Criteria
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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: 1. Age < 18 years.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Cohort Study, Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Cohort<br>Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy | Diagnostic Test: Diagnostic Arthroscopy using the Arthrex NanoScope<br>* A diagnostic arthroscopy will be performed with the Arthrex NanoScope. Structures evaluated: Radial styloid Proximal scaphoid articular cartilage Scaphoid fossa Radioscaphocapitate (RSC) ligament Long radiolunate (LRL) ligament Short radiolunate (SRL) ligament Scapholunate (SL) ligament Proximal lunate articular cartilage Lunate fossa Triangular fibrocartilage complex (TFCC) The attending performing the diagnostic arthroscopy will make an initial diagnostic assessment based on the presence/location/severity of synovitis, articular cartilage integrity, ligament injury and determine the intended treatment.<br>Diagnostic Test: Diagnostic Arthroscopy using standard arthroscopic instruments<br>* A diagnostic arthroscopy will be performed with the standard arthroscopic instruments. Structures evaluated: Radial styloid Proximal scaphoid articular cartilage Scaphoid fossa Radioscaphocapitate (RSC) ligament Long radiolunate (LRL) ligament Short radiolunate (SRL) ligament Scapholunate (SL) ligament Proximal lunate articular cartilage Lunate fossa Triangular fibrocartilage complex (TFCC) The attending performing the diagnostic arthroscopy will make the final diagnostic assessment based on the presence/location/severity of synovitis, articular cartilage integrity, and ligament injury and determine the final treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |