Hospital for Special Surgery Knee Arthroplasty Cohort

NCT00454467 | Active Not Recruiting DMC

• 1 other identifier: 2015-093
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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. Most health related quality of life studies in THA and TKA only report data up to twelve months post-operatively. In addition, most large studies of TKA and THA have been performed in Medicare patients. While these databases are important in providing population based data, Medicare studies do not permit any direct patient contact, and provide no information on patients under 65. Existing studies have also investigated predictors of patient outcome at one and two years after joint arthroplasty. However, very little is known about predictors of prosthesis failure, and there are no validated clinical indicators for choosing one prosthesis model over another. Once a device is FDA approved, there is very little motivation on the part of the developer to perform complete post-marketing research, despite the importance of these data to the public health. Most existent studies are not powered to compare differences between models. The purpose of this study is to establish a prospective cohort of HSS total knee arthroplasty.

Conditions

Knee Arthroplasty

Interventions

Satisfaction data will be extracted from Press/Ganey and on follow-up questionnaires PROCEDURE

Follow-up questionnaires will be mailed to participants.

Operative Data PROCEDURE

Type of prosthesis and other operative data will be uploaded into our database.

Intra-operative data will be collected post-operatively PROCEDURE

Research assistants will post-operatively collect data from patient charts.

In-hospital post-operative data will be collected PROCEDURE

Research assistants will collect information about hospital stay from patient charts.

Follow-up questionnaires PROCEDURE

Participants will be mailed follow-up questionnaires.

Baseline Questionnaire PROCEDURE

Patients will fill out a baseline questionnaire prior to surgery.

Cost Data PROCEDURE

Cost Data will be collected via hospital billing databases.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• years or older
• Undergoing total knee arthroplasty at HSS
• Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Links

• CERTS tools and resources

MeSH Terms

Interventions

Surveys and Questionnaires; Cost-Benefit Analysis

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Costs and Cost Analysis; Economics; Health Care Economics and Organizations

Study Officials

• Thomas Sculco, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 29, 2007
• First Posted: March 30, 2007
• Study Start: April 1, 2007
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-01

Locations

US (1)