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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Cohort | Experimental | Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Arthroscopy using the Arthrex NanoScope | Diagnostic Test | A diagnostic arthroscopy will be performed with the Arthrex NanoScope. Structures evaluated:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| 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. | Day 1 |
| 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. | Day 1 |
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Surgeon-rated Ease of Use of Conventional Instrument |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nader Paksima | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
beginning 9 months and ending 36 months following article publication
Requests should be directed to ali.azad@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
Diagnostic Arthroscopy using standard arthroscopic instruments: A diagnostic arthroscopy will be performed with the standard arthroscopic instruments. Structures evaluated:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
Diagnostic Arthroscopy using standard arthroscopic instruments: A diagnostic arthroscopy will be performed with the standard arthroscopic instruments. Structures evaluated:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
1 Day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
Diagnostic Arthroscopy using standard arthroscopic instruments: A diagnostic arthroscopy will be performed with the standard arthroscopic instruments. Structures evaluated:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nader Paksima | NYU Langone Health | 2122632193 | Nader.Paksima@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2020 | Oct 11, 2023 | Prot_SAP_000.pdf |
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Prospective Cohort Study, Diagnostic
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|
| Diagnostic Arthroscopy using standard arthroscopic instruments | Diagnostic Test | A diagnostic arthroscopy will be performed with the standard arthroscopic instruments. Structures evaluated:
|
|
Ease of use will be rated on a 5-point scale: (1) - very difficult; (2) - difficult; (3) - neutral; (4) - easy; (5) - very easy.
| Day 1 |
| 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. | Day 1 |
| 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. | Day 1 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
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