Wrist Arthropathy
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTDiagnostic 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_TESTDiagnostic 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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective Cohort Study, Diagnostic
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years. 2. Wrist pathology based on clinical examination/imaging studies undergoing wrist arthroscopy for further evaluation/treatment. 3. Willingness to participate in the study
Exclusion criteria
* 1\. Age \< 18 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon-Rated Midcarpal Visualization With Conventional Instrument | Day 1 | Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent. |
| Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope | Day 1 | Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent. |
| Surgeon-Rated Radiocarpal Visualization With Conventional Instrument | Day 1 | Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent. |
| Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope | Day 1 | Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon-rated Ease of Use of Arthrex NanoScope | 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. |
| Surgeon-rated Ease of Use of Conventional Instrument | 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. |
| Surgeon-rated Confidence in Arthrex NanoScope Diagnosis | 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. |
| Surgeon-rated Confidence in Conventional Instrument Diagnosis | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Experimental Cohort |
|---|---|
| Age, Continuous | 39.8 years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope
Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cohort | Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope | 5 score on a scale | Standard Deviation 0 |
Primary
Surgeon-Rated Midcarpal Visualization With Conventional Instrument
Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cohort | Surgeon-Rated Midcarpal Visualization With Conventional Instrument | 3.9 score on a scale | Standard Deviation 2.02 |
Primary
Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope
Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cohort | Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope | 4.95 score on a scale | Standard Deviation 0.22 |
Primary
Surgeon-Rated Radiocarpal Visualization With Conventional Instrument
Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cohort | Surgeon-Rated Radiocarpal Visualization With Conventional Instrument | 4.75 score on a scale | Standard Deviation 1.12 |
Secondary
Surgeon-rated Confidence in Arthrex NanoScope Diagnosis
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cohort | Surgeon-rated Confidence in Arthrex NanoScope Diagnosis | 5 score on a scale | Standard Deviation 0 |
Secondary
Surgeon-rated Confidence in Conventional Instrument Diagnosis
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cohort | Surgeon-rated Confidence in Conventional Instrument Diagnosis | 4.75 score on a scale | Standard Deviation 1.12 |
Secondary
Surgeon-rated Ease of Use of Arthrex NanoScope
Ease of use will be rated on a 5-point scale: (1) - very difficult; (2) - difficult; (3) - neutral; (4) - easy; (5) - very easy.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cohort | Surgeon-rated Ease of Use of Arthrex NanoScope | 4.9 score on a scale | Standard Deviation 0.31 |
Secondary
Surgeon-rated Ease of Use of Conventional Instrument
Ease of use will be rated on a 5-point scale: (1) - very difficult; (2) - difficult; (3) - neutral; (4) - easy; (5) - very easy.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cohort | Surgeon-rated Ease of Use of Conventional Instrument | 4.75 score on a scale | Standard Deviation 1.12 |