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Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01582984
Enrollment
176
Registered
2012-04-23
Start date
2008-02-29
Completion date
2009-08-31
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroplasty

Keywords

consent, Patient Understanding, Knee Arthroplasty

Brief summary

A structured consent process, in combination with one or a number of the aforementioned modalities (nursing education, handout, video, etc), may reasonably be expected to improve surgical informed consent. The investigators hypothesized that overall patient knowledge/retention would be influenced by the type of consent process and that more intensive training and review would result in better patient retention and recall. The investigators further hypothesized that the knowledge retention would decline following the consent process and surgery, but in a stratified manner based on the nature of preoperative teaching.

Detailed description

please see details above

Interventions

OTHERvideo or education session in addition to standard consent

Video added to standard consent + handout Video + education session added to standard consent + handout

Sponsors

jasvinder singh
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No

Inclusion criteria

1. recommended total knee arthroplasty

Exclusion criteria

1. Unwilling to participate 2. Unable to complete questionnaire in English

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of efficacy and complications6-week postoperativeanswers to questionnaire assessing knowledge

Secondary

MeasureTime frameDescription
knowledge regarding procedural questions with regard to the surgery and implantsDay of surgery and 6-week postoperativeAnswers to Question 4-6 on knowledge questionnaire
knowledge regarding risks of surgeryday of surgery and postoperative 6-weeksanswers to Questions 7-9 on quetionnaire
Knowledge regarding peri- and post-operative resultsday of surgery and postoperative 6-weeksanswers to Questions 10-13 on quetionnaire
Patient satisfactionday of surgery and postoperative 6-weeksanswers to satisfaction Question on quetionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026