Wrist Arthroscopy Study

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

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.

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.

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.

Diagnostic accuracy of the Arthrex Nanoscope will be described as a incidence/percentage compared to the diagnosis determined by wrist arthroscopy with conventional instruments.

Ease of use will be rated on a 5-point scale: (1) - very difficult; (2) - difficult; (3) - netural; (4) - easy; (5) - very easy.

Confidence will be rated on a 5-point scale: (1) - not at all confident; (2) - not very confident; (3) - netural; (4) - fairly confident; (5) - very confident.

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.

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Requests should be directed to ali.azad@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.