Comparison of the Accuracy of Telehealth Examination Vers... | NCT03906630

Studies
Comparison of the Accuracy of Telehealth Examination Versus Clinical Examination in the Detection of Rotator Cuff Tears

NCT03906630

Sponsor

Duke University

Status

Completed

Last Update Posted

Nov 16, 2020Actual

Enrollment

65Actual

Phase

Not provided

Conditions

Rotator Cuff Tear

Interventions

Telehealth clinical exam
Standard clinical exam

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 19, 2019Actual

Primary Completion Date

Nov 5, 2020Actual

Completion Date

Nov 5, 2020Actual

First Submitted Date

Apr 5, 2019

First Submission Date that Met QC Criteria

Apr 5, 2019

First Posted Date

Apr 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2020

Last Update Posted Date

Nov 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare how accurately a pseudo-telehealth shoulder examination diagnoses rotator cuff tears compared to a regular clinical examination. MRI is used as the gold standard.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shoulder patients			Diagnostic Test: Telehealth clinical exam Diagnostic Test: Standard clinical exam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telehealth clinical exam	Diagnostic Test	This is a pseudo telehealth clinical exam for patients presenting with shoulder pain	Shoulder patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Agreement with MRI findings as they pertain to presence or absence of a rotator cuff tear	% of exams that agreed with the MRI findings	Within 1 month of exam

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

40 years of age or older, presenting with shoulder pain, and seen in the Duke Sports Medicine clinic by Dr. Wittstein or Dr. Lassiter

Exclusion Criteria:

Patient cannot have had prior shoulder arthroplasty, instability or history of fracture/dislocation. Pregnant women will be excluded from the study because there will be an MRI. Anyone unable or unwilling to have an MRI will be excluded from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients over 40 with shoulder pain that can be MRIed

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jocelyn Wittstein, MD	Duke Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southeastern Orthopedics Shoulder Center		Raleigh	North Carolina	27609	United States
Duke Health Heritage

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32871264	Result	Bradley KE, Cook C, Reinke EK, Vinson EN, Mather RC 3rd, Riboh J, Lassiter T, Wittstein JR. Comparison of the accuracy of telehealth examination versus clinical examination in the detection of shoulder pathology. J Shoulder Elbow Surg. 2021 May;30(5):1042-1052. doi: 10.1016/j.jse.2020.08.016. Epub 2020 Aug 29.

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries