NCT00527839

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Apr 2007Apr 2027

Study Start

First participant enrolled

April 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2007

Completed
19.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 12, 2026

Status Verified

November 1, 2025

Enrollment Period

20 years

First QC Date

September 7, 2007

Last Update Submit

February 11, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years or older and undergoing total shoulder arthroplasty at HSS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Related Links

Study Officials

  • Robert Marx, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Marx, MD

CONTACT

Anthony Finocchiaro, BA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2007

First Posted

September 11, 2007

Study Start

April 1, 2007

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 12, 2026

Record last verified: 2025-11

Locations