Wrist ArthropathyNCT04457362
Wrist Arthroscopy Study
A study testing Diagnostic Arthroscopy using the Arthrex NanoScope and Diagnostic Arthroscopy using standard arthroscopic instruments in people with Wrist Arthropathy, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Arthropathy
- What is being tested?
- Diagnostic Arthroscopy using the Arthrex NanoScope and Diagnostic Arthroscopy using standard arthroscopic instruments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2020to 22 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Wrist pathology based on clinical examination/imaging studies undergoing wrist arthroscopy for further evaluation/treatment.
- Willingness to participate in the study
Who cannot join
- 1. Age < 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Evaluating the Diagnostic Accuracy of Wrist Arthroscopy Using the NanoScope Compared to Conventional Arthroscopic Instrumentation
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.
- Conditions
- Wrist Arthropathy
- Being tested
- Diagnostic Arthroscopy using the Arthrex NanoScope, Diagnostic Arthroscopy using standard arthroscopic instruments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Arthroscopy using the Arthrex NanoScopeDiagnostic 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 instrumentsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Cohort | Experimental | Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy Receives: Diagnostic Test: Diagnostic Arthroscopy using the Arthrex NanoScope; Diagnostic Test: Diagnostic Arthroscopy using standard arthroscopic instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Secondary outcomes (4)
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.
Measured: Day 1
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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start10 Oct 2020
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wrist ArthropathyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Cohort Study, Diagnostic
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nader Paksima, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457362
- Sponsor's protocol ID
- 20-00356
- Status last verified
- Oct 2023
- First submitted
- 30 Jun 2020
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Evaluating the Diagnostic Accuracy of Wrist Arthroscopy Using the NanoScope Compared to Conventional Arthroscopic Instrumentation
- ClinicalTrials.gov ID
- NCT04457362
- Acronym / sponsor ID
- 20-00356
- Conditions
- Wrist Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort Study, Diagnostic
| Arm | Type | Receives |
|---|---|---|
| Experimental Cohort | Experimental | Diagnostic Test: Diagnostic Arthroscopy using the Arthrex NanoScope, Diagnostic Test: Diagnostic Arthroscopy using standard arthroscopic instrumentsPatients with clinically diagnosed wrist pathology undergoing wrist arthroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years.
- Wrist pathology based on clinical examination/imaging studies undergoing wrist arthroscopy for further evaluation/treatment.
- Willingness to participate in the study
Key exclusion criteria (1 listed)
- 1. Age < 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Arthroscopy using the Arthrex NanoScopeA 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 test | Experimental Cohort |
| Diagnostic Arthroscopy using standard arthroscopic instrumentsA 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. | Diagnostic test | Experimental Cohort |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Surgeon-rated Ease of Use of Arthrex NanoScope
Time frame: Day 1
Surgeon-rated Ease of Use of Conventional Instrument
Time frame: Day 1
Surgeon-rated Confidence in Arthrex NanoScope Diagnosis
Time frame: Day 1
Surgeon-rated Confidence in Conventional Instrument Diagnosis
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Wrist Arthropathy
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
Rheumatic Arthritis
Recruiting
Web-based Rehabilitation After Surgical Salvage Procedures for Wrist Osteoarthritis
Wrist Osteoarthritis
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Active, not recruitingPhase 4
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
Recruiting
Effect of Lavender Aromatherapy Massage on Pain and Wrist Mobility in Rheumatoid Arthritis
Rheumatoid Arthritis (RA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nader Paksima principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Arthroscopy using the Arthrex NanoScope and Diagnostic Arthroscopy using standard arthroscopic instruments in people with Wrist Arthropathy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.