NCT00197977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2001

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

2.8 years

First QC Date

September 12, 2005

Last Update Submit

November 22, 2011

Conditions

Knee OsteoarthritisArthroplasty, Replacement, Knee

Keywords

knee arthritistotal knee arthroplastyexpectationseducation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Interventions

Educational program to address patients' expectationsBEHAVIORAL

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (5)

  • 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.

    PMID: 11451969BACKGROUND

  • 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.

    PMID: 8676117BACKGROUND

  • 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.

    PMID: 12209481BACKGROUND

  • 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.

    PMID: 1469013BACKGROUND

  • 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.

    PMID: 18196427RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Carol A Mancuso, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

November 1, 2001

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

US(1)