N/A N=20 Diagnostic

Wrist Arthroscopy Study

Wrist Arthropathy

Bottom Line

View on ClinicalTrials.gov: NCT04457362 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope — 4.95 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Diagnostic Arthroscopy using the Arthrex NanoScope (Diagnostic_test); Diagnostic Arthroscopy using standard arthroscopic instruments (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope	4.95	—
PRIMARY Surgeon-Rated Radiocarpal Visualization With Conventional Instrument	4.75	—
PRIMARY Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope	5	—
PRIMARY Surgeon-Rated Midcarpal Visualization With Conventional Instrument	3.9	—
SECONDARY Surgeon-rated Ease of Use of Arthrex NanoScope	4.9	—
SECONDARY Surgeon-rated Ease of Use of Conventional Instrument	4.75	—
SECONDARY Surgeon-rated Confidence in Arthrex NanoScope Diagnosis	5	—
SECONDARY Surgeon-rated Confidence in Conventional Instrument Diagnosis	4.75	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04457362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.