Wrist Arthroscopy Study

Not Applicable

Completed

• Conditions: Wrist Arthropathy
• Interventions: Diagnostic Test: Diagnostic Arthroscopy using the Arthrex NanoScope; Diagnostic Test: Diagnostic Arthroscopy using standard arthroscopic instruments

• Registration Number: NCT04457362
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Study Start: 2020-10-10
• Primary Completion: 2023-03-22
• Study Completion: 2023-03-22
• Status Verified: 2023-10
• Results First Submitted: 2023-10-11
• Results First Submitted QC: 2023-10-11
• Last Update Submitted: 2023-10-11
• Results First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

• 1. Age < 18 years.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Cohort	Diagnostic Arthroscopy using the Arthrex NanoScope	Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy
Experimental Cohort	Diagnostic Arthroscopy using standard arthroscopic instruments	Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy

Primary Outcome Measures

Name	Time	Method
Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope	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	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	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	Day 1	Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.

Secondary Outcome Measures

Name	Time	Method
Surgeon-rated Ease of Use of Arthrex NanoScope	Day 1	Ease of use will be rated on a 5-point scale: (1) - very difficult; (2) - difficult; (3) - neutral; (4) - easy; (5) - very easy.
Surgeon-rated Ease of Use of Conventional Instrument	Day 1	Ease of use will be rated on a 5-point scale: (1) - very difficult; (2) - difficult; (3) - neutral; (4) - easy; (5) - very easy.
Surgeon-rated Confidence in Arthrex NanoScope Diagnosis	Day 1	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.
Surgeon-rated Confidence in Conventional Instrument Diagnosis	Day 1	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States