Hospital for Special Surgery Shoulder Arthroplasty Cohort | NCT00527839 | Trialant
NCT00527839
Sponsor
Hospital for Special Surgery, New York
Status
Recruiting
Last Update Posted
Feb 12, 2026Actual
Enrollment
250Estimated
Phase
Not provided
Conditions
Shoulder Arthroplasty
Interventions
Not provided
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00527839
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2013-014
Secondary IDs
Not provided
Brief Title
Hospital for Special Surgery Shoulder Arthroplasty Cohort
Official Title
Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Shoulder Arthroplasty Cohort
Acronym
Not provided
Organization
Hospital for Special Surgery, New YorkOTHER
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2007
Primary Completion Date
Apr 2027Estimated
Completion Date
Apr 2027Estimated
First Submitted Date
Sep 7, 2007
First Submission Date that Met QC Criteria
Sep 10, 2007
First Posted Date
Sep 11, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 11, 2026
Last Update Posted Date
Feb 12, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hospital for Special Surgery, New YorkOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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 provided
Conditions Module
Conditions
Shoulder Arthroplasty
Keywords
Not provided
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
250Estimated
Arms/Interventions Module
No data available
No data is available for this block.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Patient Reported Outcome Measures (PROMs)
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.
Collection of at Baseline, 6 Months, 1 Year, 2 Year, 5 Year and 10 Year
Intra Operative Data
Surgeon reported data
Collection of data on Day 0 (Date of Surgery)
Demographic data
Collection of patient information and demographic data
Collection of at Baseline, 6 Months, 1 Year, 2 Year, 5 Year and 10 Year
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
We will be asking all patients undergoing a total shoulder arthroplasty to participate.