Hospital for Special Surgery Shoulder Arthroplasty Cohort
ConditionShoulder Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital for Special Surgery, New York
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older and undergoing total shoulder arthroplasty at HSS
Disqualifiers
No other exclusion criteria. Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires.
Trial population
We will be asking all patients undergoing a total shoulder arthroplasty to participate.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Collection of at Baseline, 6 Months, 1 Year, 2 Year, 5 Year and 10 Year2
Intra Operative Data
Surgeon reported data
Time frame
Collection of data on Day 0 (Date of Surgery)3
Demographic data
Collection of patient information and demographic data
Time frame
Collection of at Baseline, 6 Months, 1 Year, 2 Year, 5 Year and 10 YearSponsors and contacts
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Source ClinicalTrials.gov