Reverse Shoulder Replacement: Age 60 or Younger Outcomes

Completed

• Conditions: Shoulder Arthritis

• Registration Number: NCT03148184
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess functional change from before surgery to two years post surgery	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 Outcome Measures

Name	Time	Method
Radiographic Outcomes	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States