Skip to main content
OpenTrials
Completed

NCT Number: NCT03148184

Reverse Shoulder Replacement: Age 60 or Younger Outcomes

The purpose of this study is to assess the early outcomes following Reverse Shoulder Arthroplasty (RSA) in patients sixty years or younger for the purpose of characterizing these patients, evaluating their clinical outcomes and radiographic appearance.The investigators would like to know how quickly they are healing and returning to their baseline activities of daily living and ability to work. This will help when counseling patients prior to surgery as it will give us a better defined and study supported understanding of the post-operative recovery timeline in the younger population.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Arthritis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

This study is looking at patients who are sixty years or younger at the time of they undergo a reverse total shoulder replacement. This is an important population to look at their functional and clinical outcomes as they are often still employed and have more physical demands upon their shoulder in everyday life than the older replacement population for which there are more outcome data available. The investigators would like to determine how the younger population is healing and returning to their baseline activities of daily living and ability to work. This will help when counseling patients prior to surgery as it will give us a study supported understanding of the post-operative recovery timeline in the younger population. The investigators will review x-rays to evaluate healing at two years. Functional surveys are given pre and post operatively (1 & 2 years) and these will be reviewed as well. A physical exam is also performed to determine range of motion pre and post operatively (1 & 2 years).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 60 years old or younger at the time of surgery
  • reverse shoulder arthroplasty with a single implant system by one of our four surgeons

Exclusion criteria

  • minors
  • unable to complete imaging portion of the two-year follow-up due to health safety/exposure concerns
  • unwilling/unable to return for follow up
  • Revision procedure

Treatment and study plan

shoulder x-ray

Diagnostic Test

post operative shoulder x-ray at minimum 2 year post op

Primary outcomes

  1. Assess functional change from before surgery to two years post surgery

    Time frame: 2 years post op

    Assess changes in range of motion as part of the overall clinical outcome function scores. ASES (American Shoulder and Elbow Questionnaire)

Secondary outcomes

  1. Radiographic Outcomes

    Time frame: 2 years post op

    Evaluate the shoulder replacement for any signs of implant loosening or bone loss. X-rays are reviewed by Orthopedic Surgeons. There is either loosening present/absent and bone loss present/absent.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

Reverse Shoulder Arthroplasty in Patients 60 Years Old and Younger: Short-term Clinical and Radiographic Results

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 10, 2017
Registry last updated
Jul 17, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.