Wrist Arthroscopy Study
A Comparative Study Evaluating the Diagnostic Accuracy of Wrist Arthroscopy Using the NanoScope Compared to Conventional Arthroscopic Instrumentation
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
October 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2023
CompletedResults Posted
Study results publicly available
November 7, 2023
CompletedNovember 7, 2023
October 1, 2023
2.4 years
June 30, 2020
October 11, 2023
October 11, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (4)
Surgeon-rated Ease of Use of Arthrex NanoScope
Day 1
Surgeon-rated Ease of Use of Conventional Instrument
Day 1
Surgeon-rated Confidence in Arthrex NanoScope Diagnosis
Day 1
Surgeon-rated Confidence in Conventional Instrument Diagnosis
Day 1
Study Arms (1)
Experimental Cohort
EXPERIMENTALPatients with clinically diagnosed wrist pathology undergoing wrist arthroscopy
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age \> 18 years.
- Wrist pathology based on clinical examination/imaging studies undergoing wrist arthroscopy for further evaluation/treatment.
- Willingness to participate in the study
You may not qualify if:
- \. Age \< 18 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Results Point of Contact
- Title
- Nader Paksima
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Nader Paksima
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 7, 2020
Study Start
October 10, 2020
Primary Completion
March 22, 2023
Study Completion
March 22, 2023
Last Updated
November 7, 2023
Results First Posted
November 7, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- beginning 9 months and ending 36 months following article publication
- Access Criteria
- Requests should be directed to ali.azad@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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.