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Completed

NCT Number: NCT04457362

Wrist Arthroscopy Study

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.

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Key information

Conditions

Wrist Arthropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic Arthroscopy using the Arthrex NanoScope

Diagnostic Test

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 Arthroscopy using standard arthroscopic instruments

Diagnostic Test

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.

Primary outcomes

  1. Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope

    Time frame: Day 1

    Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.

  2. Surgeon-Rated Radiocarpal Visualization With Conventional Instrument

    Time frame: Day 1

    Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.

  3. Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope

    Time frame: Day 1

    Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.

  4. Surgeon-Rated Midcarpal Visualization With Conventional Instrument

    Time frame: Day 1

    Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.

Secondary outcomes

  1. Surgeon-rated Ease of Use of Arthrex NanoScope

    Time frame: Day 1

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

  2. Surgeon-rated Ease of Use of Conventional Instrument

    Time frame: Day 1

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

  3. Surgeon-rated Confidence in Arthrex NanoScope Diagnosis

    Time frame: Day 1

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

  4. Surgeon-rated Confidence in Conventional Instrument Diagnosis

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2020
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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