Hospital for Special Surgery Shoulder Arthroplasty Cohort

Recruiting

• Conditions: Shoulder Arthroplasty

• Registration Number: NCT00527839
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-11
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcome Measures (PROMs)	Collection of at Baseline, 6 Months, 1 Year, 2 Year, 5 Year and 10 Year	Patient reported outcomes (PROMs) at 1 year, 2 year, 5 year, 10 year follow-up time points. This information will be collected and maintained for use in future research studies with their own individually defined outcomes.
Intra Operative Data	Collection of data on Day 0 (Date of Surgery)	Surgeon reported data
Demographic data	Collection of at Baseline, 6 Months, 1 Year, 2 Year, 5 Year and 10 Year	Collection of patient information and demographic data

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States