NCT01463930

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

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

January 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 2, 2011

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

October 16, 2011

Last Update Submit

February 18, 2016

Conditions

Keywords

Total Knee ReplacementExpectationsAudiovisual videodisc

Outcome Measures

Primary Outcomes (1)

  • 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)

    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.

    Baseline and 1 month later (1 month before surgery)

Study Arms (2)

Audiovisual videodisc and medical verbal information

EXPERIMENTAL
Behavioral: Educational audiovisual videodisc and medical verbal information

Medical verbal information

ACTIVE COMPARATOR
Behavioral: Medical verbal information

Interventions

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.

Audiovisual videodisc and medical verbal information

General and specific verbal information provided by both the surgeon and a specialized nurse including basics of surgical technique, potential complications, and rehabilitation.

Medical verbal information

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with knee osteoarthritis waiting for total knee replacement.

You may not qualify if:

  • Cognitive disorders or language barriers precluding medical interview.
  • Contralateral total knee replacement.
  • History of revision total knee replacement.
  • History of unicompartmental knee arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de l'Esperança - Parc de Salut MAR

Barcelona, Barcelona, 08024, Spain

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
  • 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.

    PMID: 16967035BACKGROUND
  • 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.

    PMID: 21074356BACKGROUND
  • 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.

    PMID: 9195314BACKGROUND
  • 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.

    PMID: 19234886BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, PhD

Study Record Dates

First Submitted

October 16, 2011

First Posted

November 2, 2011

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2010

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations