Developmenet, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty

Developmenet, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty - EvAb-Pilot

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00022571

Enrollment

220

Registered

2020-12-15

Start date

2021-03-22

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

total knee arthroplasty

Interventions

Group 1: Intervention group: Patients receive evidence-based informed consent forms for Total Knee Arthroplasty and related anaesthesia procedures Group 2: Control group: Patients receive standard con

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Schedule for an elective total knee arthroplasty surgery, Ability to understand and speak German, Minimum age of 18 years, Mental competence to give consent and answer questions

Exclusion criteria

Exclusion criteria: revision or posttraumatic osteoarthritis

Design outcomes

Primary

Measure	Time frame
Anxiety: - subjective fear/anxiety of adverse events possibly caused by surgery or anesthesia - Measuring instrument: numeric rating scale 0-10 and surgical fear questionnaire - Time point: 4 weeks before surgery (baseline) and one day before surgery; Nocebo-effect: - patient reported adverse events (e.g. headache after anesthesia) - Measuring instrument: questionnaire (including closed and open questions) - Time point: 3 days after hospital discharge	—

Measure

Time frame

Anxiety: - subjective fear/anxiety of adverse events possibly caused by surgery or anesthesia - Measuring instrument: numeric rating scale 0-10 and surgical fear questionnaire - Time point: 4 weeks before surgery (baseline) and one day before surgery; Nocebo-effect: - patient reported adverse events (e.g. headache after anesthesia) - Measuring instrument: questionnaire (including closed and open questions) - Time point: 3 days after hospital discharge

—

Secondary

Measure	Time frame
satisfaction with patient-practitioner-conversation - Patients subjective satisfaction with the patient-practitioner-conversation - Measuring instrument: numeric rating scale (0-10) - Time point: One day before surgery; risk perception - Knowledge about benefits and harms of the procedure - Measuring instrument: questionnaie (knowledge questions will be derived from developing the informed consent forms) - Time point: One day before surgery; Quality of life: -Measuring instrument: numeric rating sclae (0-10) - Time point: 4 weeks after hospital discharge; pain and function (of the knee): - Measuring instrument: Oxford Knee Score (questionnaire) - Time point: 4 weeks after hospital discharge	—

Measure

Time frame

satisfaction with patient-practitioner-conversation - Patients subjective satisfaction with the patient-practitioner-conversation - Measuring instrument: numeric rating scale (0-10) - Time point: One day before surgery; risk perception - Knowledge about benefits and harms of the procedure - Measuring instrument: questionnaie (knowledge questions will be derived from developing the informed consent forms) - Time point: One day before surgery; Quality of life: -Measuring instrument: numeric rating sclae (0-10) - Time point: 4 weeks after hospital discharge; pain and function (of the knee): - Measuring instrument: Oxford Knee Score (questionnaire) - Time point: 4 weeks after hospital discharge

—

Countries

Germany

Contacts

Public ContactAlina Weise

Universität Witten/HerdeckeInstitut für Forschung in der Operativen Medizin (IFOM)

Alina.Weise@uni-wh.de0221 9895741

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 22, 2026