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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00197977
Other study ID # 98101
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated November 22, 2011
Start date November 2001
Est. completion date September 2004

Study information

Verified date November 2011
Source Hospital for Special Surgery, New York
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date September 2004
Est. primary completion date September 2004
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Intervention

Behavioral:
Educational program to address patients' expectations


Locations

Country Name City State
United States Hospital for Special Surgery New York New York

Sponsors (1)

Lead Sponsor Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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/s11999-007-005 — View 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. — View 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-A(7):1005-12. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Secondary The secondary outcome is to compare patient-reported symptoms with radiographic ratings of disease activity. No
Secondary The secondary outcome is to determine if expectations after the class coincide more closely with orthopedic surgeons expectations No
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