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OpenTrials
Completed

NCT Number: NCT01582984

Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

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.

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Key information

Conditions

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

About this study

please see details above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • recommended total knee arthroplasty

Exclusion criteria

  • Unwilling to participate
  • Unable to complete questionnaire in English

Treatment and study plan

video or education session in addition to standard consent

Other

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

Primary outcomes

  1. Knowledge of efficacy and complications

    Time frame: 6-week postoperative

    answers to questionnaire assessing knowledge

Secondary outcomes

  1. knowledge regarding procedural questions with regard to the surgery and implants

    Time frame: Day of surgery and 6-week postoperative

    Answers to Question 4-6 on knowledge questionnaire

  2. knowledge regarding risks of surgery

    Time frame: day of surgery and postoperative 6-weeks

    answers to Questions 7-9 on quetionnaire

  3. Knowledge regarding peri- and post-operative results

    Time frame: day of surgery and postoperative 6-weeks

    answers to Questions 10-13 on quetionnaire

  4. Patient satisfaction

    Time frame: day of surgery and postoperative 6-weeks

    answers to satisfaction Question on quetionnaire

Sponsors and collaborators

Lead sponsor

jasvinder singh

Fed

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 23, 2012
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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