Hospital for Special Surgery Shoulder Arthroplasty Cohort

Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Shoulder Arthroplasty Cohort

Total joint replacements are some of the most successful medical devices developed over the last fifty years. They enable millions of people to remain ambulatory and pain free, with minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements, and 25,000 total or partial shoulder replacements were performed in the United States (HCUP data). Future use will likely be even higher: it is estimated that by the year 2020, the population 65 and over in developed countries will increase by 71%. Existing studies do not provide adequate prospective data to evaluate long-term outcomes.

HSS is a world leader in total joint replacement including total shoulder arthroplasty. However, there is no systematic follow-up or evaluation of patients who have their shoulders replaced here.

The purpose of this study is to establish a prospective cohort of HSS total shoulder arthroplasty to evaluate predictors of outcome, causes of failure and to allow ongoing evaluation of the results of our patients over time.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Arthroplasty

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Robert Marx, MD; Phone Number: 212-606-1645
• Study Contact Backup: Name: Kaitlyn Lillemoe, BA; Phone Number: 212-606-1866; Email: lillemoek@hss.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Contact: Kaitlyn Lillemoe; Email: lillemoek@hss.edu
      • Contact: Gina Aharonoff; Phone Number: 646-797-8904; Email: aharonoffg@hss.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We will be asking all patients undergoing a total shoulder arthroplasty to participate.

Description

Inclusion Criteria:

• 18 years or older and undergoing total shoulder arthroplasty at HSS

Exclusion Criteria:

• No other exclusion criteria. Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Robert Marx, MD, Hospital for Special Surgery, New York

Publications and helpful links

Helpful Links

• CERTS tools and resources

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 7, 2007
• First Submitted That Met QC Criteria: September 10, 2007
• First Posted (Estimated): September 11, 2007

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2013-014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No