๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-11

Hospital for Special Surgery Knee Arthroplasty Cohort (NCT00454467)

Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: The HSS Knee Arthroplasty Cohort

๐Ÿ”ต Active, Not Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Hospital for Special Surgery, New York

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Hospital for Special Surgery โ€” New York, New York

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • Baseline Questionnaire (PROCEDURE)
  • Operative Data (PROCEDURE)
  • Intra-operative data will be collected post-operatively (PROCEDURE)
  • In-hospital post-operative data will be collected (PROCEDURE)
  • Satisfaction data will be extracted from Press/Ganey and on follow-up questionnaires (PROCEDURE)
  • Cost Data (PROCEDURE)
  • Follow-up questionnaires (PROCEDURE)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Hospital for Special Surgery โ€” New York, New York

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Knee Arthroplasty

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—