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Reverse Shoulder Replacement: Age 60 or Younger Outcomes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03148184
Enrollment
96
Registered
2017-05-10
Start date
2016-11-30
Completion date
2019-02-28
Last updated
2019-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Arthritis

Keywords

reverse total shoulder arthroplasty, 60 years old or younger, outcomes

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).

Interventions

DIAGNOSTIC_TESTshoulder x-ray

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

Sponsors

Zimmer Biomet
CollaboratorINDUSTRY
Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Assess functional change from before surgery to two years post surgery2 years post opAssess changes in range of motion as part of the overall clinical outcome function scores. ASES (American Shoulder and Elbow Questionnaire)

Secondary

MeasureTime frameDescription
Radiographic Outcomes2 years post opEvaluate 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026