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Reverse Shoulder Replacement: Age 60 or Younger Outcomes

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ClinicalTrials.gov Identifier: NCT03148184
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Shoulder Arthritis 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).

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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 : November 2016
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays


Intervention Details:
  • Diagnostic Test: shoulder x-ray
    post operative shoulder x-ray at minimum 2 year post op


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients age 60 or younger who are will undergo or have undergone a primary reverse shoulder arthroplasty with a single implant system by one of our four surgeons.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148184


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Zimmer Biomet
Investigators
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Principal Investigator: Aaron Chamberlain, MD Washington University School of Medicine
Publications:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03148184    
Other Study ID Numbers: 201408124
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
reverse total shoulder arthroplasty
60 years old or younger
outcomes
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases