Wrist Arthroscopy Study

NCT ID: NCT04457362

Last Updated: 2023-11-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2023-03-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wrist Arthropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective Cohort Study, Diagnostic
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Cohort

Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy

Group Type EXPERIMENTAL

Diagnostic Arthroscopy using the Arthrex NanoScope

Intervention Type DIAGNOSTIC_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 instruments

Intervention Type DIAGNOSTIC_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nader Paksima

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NYU Langone Health

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-00356

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hand Transplantation
NCT02476838 RECRUITING NA
Ultrasound Guided Arthrocentesis
NCT00537589 COMPLETED NA
Lower Tourniquet Pressure Study
NCT04994405 COMPLETED NA