NCT04457362

Wrist Arthroscopy Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-10-10
• Primary completion: 2023-03-22
• Completion: 2023-03-22
• First posted: 2020-07-07
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study