Addressing Patients' Expectations of Total Knee Arthroplasty in a Randomized Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00197977
First received: September 12, 2005
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

The goals of this study are to develop and test an educational intervention to address patients' expectations of long-term outcomes of total knee arthroplasty.


Condition Intervention
Knee Osteoarthritis
Arthroplasty, Replacement, Knee
Behavioral: Educational program to address patients' expectations

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Addressing Patients' Expectations of Total Knee Arthroplasty: Developing and Testing an Educational Intervention in a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • The primary outcome is the within-patient change between pre and post program scores measured by the Hospital for Special Surgery Total Knee Replacement Expectations Survey. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome is to compare patient-reported symptoms with radiographic ratings of disease activity. [ Designated as safety issue: No ]
  • The secondary outcome is to determine if expectations after the class coincide more closely with orthopedic surgeons expectations [ Designated as safety issue: No ]

Enrollment: 146
Study Start Date: November 2001
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Detailed Description:

The first goal of this study is to develop an educational intervention to address patients' expectations of long-term outcomes of total knee arthroplasty. The intervention will be structured according to the expectations listed in the Hospital for Special Surgery Total Knee Replacement Expectations Survey. The second goal is to test the intervention in a randomized trial. An additional goal is to compare patients' self-reported knee symptoms with radiographic findings.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be eligible for this study if they are 40 years of age or older and are scheduled for primary total knee arthroplasty at the Hospital for Special Surgery.

Exclusion Criteria:

  • Patients will be excluded from this study for the following reasons: if they are not fluent in English; if they are not going to attend the preoperative knee replacement class; if they are unable to complete the surveys; if they refuse to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197977

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Carol A Mancuso, MD Hospital for Special Surgery, New York
  More Information

Publications:
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00197977     History of Changes
Other Study ID Numbers: 98101
Study First Received: September 12, 2005
Last Updated: November 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Hospital for Special Surgery, New York:
knee arthritis
total knee arthroplasty
expectations
education

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014