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OpenTrials
Completed

NCT Number: NCT04416932

Ultrasound After Total Shoulder Arthroplasty

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.

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Key information

Conditions

Total Shoulder Arthroplasty Rotator Cuff Injuries Rotator Cuff Tears Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Revision shoulder arthroplasty for infection
  • Pregnancy

Treatment and study plan

Ultasound

Procedure

Evaluation of post-operative patients who have had total shoulder arthroplasty and will assess the integrity of the rotator cuff using ultrasound.

Primary outcomes

  1. Number of confirmed healed rotator cuff tear as measured by ultrasound

    Time frame: time of procedure, up to 1 hour

  2. Number of confirmed non-healed tenotomy

    Time frame: time of procedure, up to 1 hour

  3. Number of confirmed rotator cuff tears

    Time frame: time of procedure, up to 1 hour

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Piedmont Orthopedic Society

Registry information

Official study title

Advanced Imaging for Shoulder and Elbow Arthroplasty

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2020
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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