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

Primary Purpose

Knee Osteoarthritis, Arthroplasty, Replacement, Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational program to address patients' expectations
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Knee Osteoarthritis focused on measuring knee arthritis, total knee arthroplasty, expectations, education

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital for Special Surgery

Outcomes

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.

Secondary Outcome Measures

The secondary outcome is to compare patient-reported symptoms with radiographic ratings of disease activity.
The secondary outcome is to determine if expectations after the class coincide more closely with orthopedic surgeons expectations

Full Information

First Posted
September 12, 2005
Last Updated
November 22, 2011
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT00197977
Brief Title
Addressing Patients' Expectations of Total Knee Arthroplasty in a Randomized Trial
Official Title
Addressing Patients' Expectations of Total Knee Arthroplasty: Developing and Testing an Educational Intervention in a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Arthroplasty, Replacement, Knee
Keywords
knee arthritis, total knee arthroplasty, expectations, education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Educational program to address patients' expectations
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
The secondary outcome is to compare patient-reported symptoms with radiographic ratings of disease activity.
Title
The secondary outcome is to determine if expectations after the class coincide more closely with orthopedic surgeons expectations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol A Mancuso, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11451969
Citation
Mancuso CA, Sculco TP, Wickiewicz TL, Jones EC, Robbins L, Warren RF, Williams-Russo P. Patients' expectations of knee surgery. J Bone Joint Surg Am. 2001 Jul;83(7):1005-12. doi: 10.2106/00004623-200107000-00005.
Results Reference
background
PubMed Identifier
8676117
Citation
Mancuso CA, Ranawat CS, Esdaile JM, Johanson NA, Charlson ME. Indications for total hip and total knee arthroplasties. Results of orthopaedic surveys. J Arthroplasty. 1996 Jan;11(1):34-46. doi: 10.1016/s0883-5403(96)80159-8.
Results Reference
background
PubMed Identifier
12209481
Citation
Blake VA, Allegrante JP, Robbins L, Mancuso CA, Peterson MG, Esdaile JM, Paget SA, Charlson ME. Racial differences in social network experience and perceptions of benefit of arthritis treatments among New York City Medicare beneficiaries with self-reported hip and knee pain. Arthritis Rheum. 2002 Aug;47(4):366-71. doi: 10.1002/art.10538.
Results Reference
background
PubMed Identifier
1469013
Citation
Peterson MG, Hollenberg JP, Szatrowski TP, Johanson NA, Mancuso CA, Charlson ME. Geographic variations in the rates of elective total hip and knee arthroplasties among Medicare beneficiaries in the United States. J Bone Joint Surg Am. 1992 Dec;74(10):1530-9.
Results Reference
background
PubMed Identifier
18196427
Citation
Mancuso CA, Graziano S, Briskie LM, Peterson MG, Pellicci PM, Salvati EA, Sculco TP. Randomized trials to modify patients' preoperative expectations of hip and knee arthroplasties. Clin Orthop Relat Res. 2008 Feb;466(2):424-31. doi: 10.1007/s11999-007-0052-z. Epub 2008 Jan 10.
Results Reference
result

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

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