- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463930
Audiovisual Videodisc Education and Modification of Expectations With Total Knee Replacement (TKR)
February 18, 2016 updated by: Joan Leal Blanquet, Parc de Salut Mar
Effects of an Educational Audiovisual Videodisc on Patients' Pre-operative Expectations With Total Knee Replacement: a Randomized Study
Information provided to patients modifies their expectations with surgery.
The effects of preoperative audiovisual information on expectations with total knee replacement (TKR) have not been investigated.
The purposes of this study were to investigate the effectiveness of an educational videodisc on the modification of pre-operative patients' expectations with TKR and to find a biophysical profile of subjects in whom this videodisc could be most effective.
It was hypothesized that patients receiving standard information plus additional medical information through audiovisual videodiscs would modify their pre-operative expectations more than those only receiving the standard information through medical interviews.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Barcelona, Spain, 08024
- Hospital de l'Esperança - Parc de Salut MAR
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with knee osteoarthritis waiting for total knee replacement.
Exclusion Criteria:
- Cognitive disorders or language barriers precluding medical interview.
- Contralateral total knee replacement.
- History of revision total knee replacement.
- History of unicompartmental knee arthroplasty
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Audiovisual videodisc and medical verbal information
|
General and specific medical verbal information and ten-minute DVD where the process from admission to the surgical intervention, recovery room, immediate postoperative care, and outpatient care at two, six, and twelve months after surgery was shown.
The video included experiences of patients with respect to pain and function and examples of functionality during daily life activities such as stairs, kneeling or squatting.
The video also demonstrated the facilities and rehabilitation techniques employed in the Physical Medicine and Rehabilitation Service.
|
Active Comparator: Medical verbal information
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General and specific verbal information provided by both the surgeon and a specialized nurse including basics of surgical technique, potential complications, and rehabilitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in patient-reported postoperative expectatives about the results of total knee replacement to inmediately after receiving audiovisual plus verbal information (intervention grou) or only verbal information (control group)
Time Frame: Baseline and 1 month later (1 month before surgery)
|
The study measures the patient's expectatives about the improvement of pain, function, and psychological well-being after undergoing total knee replacement.
These expectatives are measured through the Hospital for Special Surgery Knee Replacement Expectations Survey (KRES), and a score ranging from 0 to 100 is reported.
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Baseline and 1 month later (1 month before surgery)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.
- Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. doi: 10.1016/s0883-5403(97)90194-7.
- 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.
- Nilsdotter AK, Toksvig-Larsen S, Roos EM. Knee arthroplasty: are patients' expectations fulfilled? A prospective study of pain and function in 102 patients with 5-year follow-up. Acta Orthop. 2009 Feb;80(1):55-61. doi: 10.1080/17453670902805007.
- Hepinstall MS, Rutledge JR, Bornstein LJ, Mazumdar M, Westrich GH. Factors that impact expectations before total knee arthroplasty. J Arthroplasty. 2011 Sep;26(6):870-6. doi: 10.1016/j.arth.2010.09.010. Epub 2010 Nov 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
October 16, 2011
First Submitted That Met QC Criteria
October 31, 2011
First Posted (Estimate)
November 2, 2011
Study Record Updates
Last Update Posted (Estimate)
February 19, 2016
Last Update Submitted That Met QC Criteria
February 18, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- PSMARCOT01_2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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