Reverse Shoulder Replacement: Age 60 or Younger Outcomes

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03148184
Collaborator
Zimmer Biomet (Industry)
96
1
27
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: shoulder x-ray

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 Design

Study Type:
Observational
Actual Enrollment :
96 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Reverse Shoulder Arthroplasty in Patients 60 Years Old and Younger: Short-term Clinical and Radiographic Results
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Feb 1, 2019
Actual Study Completion Date :
Feb 1, 2019

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine
  • Zimmer Biomet

Investigators

  • Principal Investigator: Aaron Chamberlain, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03148184
Other Study ID Numbers:
  • 201408124
First Posted:
May 10, 2017
Last Update Posted:
Jul 17, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Washington University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2019