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OpenTrials
Completed

NCT Number: NCT03111147

Impact of Humeral Component Version on Outcomes Following RTSA

The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont Health

Royal Oak, Michigan, 48073, United States

About this study

Retrospective clinical evidence suggests that increasing humeral component retroversion does not affect measured internal or external rotation, however patients with neutral version may experience better function with daily activities requiring internal rotation compared to those with 30 degrees of retroversion. Prospective data on clinical outcomes comparing different humeral component versions in RTSA is currently lacking. The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing primary reverse total shoulder arthroplasty
  • Diagnosis of cuff tear arthropathy or primary OA with RCT
  • Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam
  • 18 years or older

Exclusion criteria

  • Revision arthroplasty
  • Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
  • Minors (under 18 years of age)
  • Prior open shoulder surgery
  • Concomitant latissimus dorsi transfer
  • Patients not undergoing a standard of care physical therapy protocol
  • Pregnant, patient-reported
  • Cognitively impaired

Treatment and study plan

0 degrees humeral component version

Device

RTSA with humeral component positioned in 0 degrees of version

30 degrees humeral component retroversion

Device

RTSA with humeral component positioned in 30 degrees of retroversion

Primary outcomes

  1. Postoperative External Range of Motion (ROM)

    Time frame: 2 years

    External range of motion measurements of the shoulder in degrees

  2. Postoperative Internal Range of Motion (ROM)

    Time frame: 2 years

    Internal range of motion measurements of the shoulder in degrees

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Official study title

The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2017
Registry last updated
Mar 5, 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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