Trial Outcomes & Findings for Wrist Arthroscopy Study (NCT NCT04457362)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Day 1

Results posted on

2023-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Cohort Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy 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 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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wrist Arthroscopy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Cohort n=20 Participants Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy 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 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.
Age, Continuous	39.8 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure	Experimental Cohort n=20 Participants Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy 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 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.
Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope	4.95 score on a scale Standard Deviation 0.22

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure	Experimental Cohort n=20 Participants Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy 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 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.
Surgeon-Rated Radiocarpal Visualization With Conventional Instrument	4.75 score on a scale Standard Deviation 1.12

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure	Experimental Cohort n=20 Participants Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy 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 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.
Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope	5 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure	Experimental Cohort n=20 Participants Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy 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 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.
Surgeon-Rated Midcarpal Visualization With Conventional Instrument	3.9 score on a scale Standard Deviation 2.02

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental Cohort n=20 Participants Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy 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 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.
Surgeon-rated Ease of Use of Arthrex NanoScope	4.9 score on a scale Standard Deviation 0.31

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental Cohort n=20 Participants Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy 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 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.
Surgeon-rated Ease of Use of Conventional Instrument	4.75 score on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental Cohort n=20 Participants Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy 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 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.
Surgeon-rated Confidence in Arthrex NanoScope Diagnosis	5 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental Cohort n=20 Participants Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy 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 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.
Surgeon-rated Confidence in Conventional Instrument Diagnosis	4.75 score on a scale Standard Deviation 1.12

Adverse Events

Experimental Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nader Paksima

NYU Langone Health

Phone: 2122632193

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place