Wrist Arthroscopy Study

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.

Conditions

• Wrist Arthropathy

Interventions

DIAGNOSTIC_TEST

Diagnostic Arthroscopy using the Arthrex NanoScope

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.

DIAGNOSTIC_TEST

Diagnostic Arthroscopy using standard arthroscopic instruments

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.

Sponsors & Collaborators

• NYU Langone Health

  lead OTHER

Principal Investigators

• Nader Paksima · NYU Langone Health

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-10

Primary Completion

2023-03-22

Completion

2023-03-22

FDA Device

Yes

Countries

• United States

Study Locations