N/A
Completed N=20
Wrist Arthroscopy Study
Wrist Arthropathy
Source: ClinicalTrials.gov NCT04457362 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope — 4.95 score on a scale
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.
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 | — |
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.
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. Informational only — not medical advice.