Ultrasound After Total Shoulder Arthroplasty

Completed

• Conditions: Rotator Cuff Injuries; Rotator Cuff Tears; Total Shoulder Arthroplasty
• Interventions: Procedure: Ultasound

• Registration Number: NCT04416932
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study would be to evaluate a group of patients status post post-total shoulder arthroplasty to assess the integrity of the rotator cuff using ultrasound. We believe ultrasonography imaging to be a comparable and efficacious modality to evalute tenotomy healing rates and diagnose rotator cuff failure after total shoulder arthroplasty. In addition, we believe ultrasonography to be a cost-effective modality to asses the rotator cuff after total shoulder arthroplasty. Our population would consist of patients that received total shoulder arthroplasty within the last 5 years.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Study Start: 2021-05-20
• Primary Completion: 2023-03-22
• Study Completion: 2023-03-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Primary or revision total shoulder arthroplasty with or without subscapularis tenotomy
• Primary or revision reverse shoulder arthroplasty with or without subscapularis tenotomy
• English speaking patients only
• Shoulder arthroplasty within the last 5 years

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Exclusion Criteria

• Revision shoulder arthroplasty for infection
• Pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-operative patients who had total shoulder arthroplasty	Ultasound	Patients who have had a total shoulder replacement will be scheduled for an ultrasound at Duke Radiology. An ultrasound will be completed on the shoulder that has been replaced, which takes no more than an hour. This ends all study involvement.

Primary Outcome Measures

Name	Time	Method
Number of confirmed healed rotator cuff tear as measured by ultrasound	time of procedure, up to 1 hour
Number of confirmed non-healed tenotomy	time of procedure, up to 1 hour
Number of confirmed rotator cuff tears	time of procedure, up to 1 hour

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States