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Use of Chatgpt for Informed Consent in Total Knee Arthroplasty: an Exploratory Randomized Clinical Trial

Use of Chatgpt for Informed Consent in Total Knee Arthroplasty: an Exploratory Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078274
Enrollment
Unknown
Registered
2023-12-03
Start date
2023-04-26
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Knee osteoarthritis

Interventions

Traditional doctor-patient discussion prior to surgical procedure:The Department uses the "TKA Brochure and Typical Cases" for pre-operative consultations with TKA patients. This brochure contains inf
secondly, he popularised and predicted the process of TKA surgery and the prognosis of the postoperative condition based on the preoperative interview data
and thirdly, he orally answered the questions raised by the patients and their family members. The patient is instructed to submit the "informed consent for surgery" form until he and his family have
ChatGPT facilitated doctor-patient communication prior to surgical procedure:The surgeon introduced the patient s current condition and the need for TKA surgery to the patients assigned to this group.

Sponsors

The First Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Individuals aged 45 to 80 years. (2) Meet the diagnostic criteria for knee osteoarthritis (KOA), that is, have "recurrent knee pain within the past month" as the primary complaint and two of the following conditions: X-rays taken in a standing or weight-bearing position reveal joint space stenosis, subchondral osteosclerosis, and/or cystic change, as well as the presence of osteophytes at the joint margin; The average duration of morning stiffness is less than 30 minutes; Actively occasionally experience a bony fricative sound (sensation). (3) Kellgren-Lawrence(KL) grade IV for preoperative full-length standing lower extremity X-ray assessment satisfies TKA surgery indications. Patients may be covered by "employee medical insurance" or "resident medical insurance." (5) At least one family member under the age of 50 must be present during the signature of the informed assent for surgery.

Exclusion criteria

Exclusion criteria: (1) Mental disorder or mental ailment patients. (2) Hip or low back discomfort was the chief complaint, and total hip replacement or knee collateral ligament reconstruction had been performed. Osteotomy of the proximal tibia or distal femur. (3) A body mass index in excess of 30 kg/m2. (4) The lower limb muscle strength test prior to TKA was grade III or less, or the patient spent more than three months in a wheelchair. (5) Diseases with a history of influencing lower limb strength, such as poliomyelitis sequelae, Parkinson's disease, etc. Or suffer from subjective cognitive-function-impairing maladies, such as Alzheimer's disease, brain atrophy, etc. (6) Charcot's joint disease or lower extremity valgus malformation or severe varus malformation (greater than 30°) or lower extremity external articular malformation (greater than 10°) diagnosis. (7)During hospitalisation, seven postoperative complications including aseptic displacement of prosthesis, periprosthesis fracture, periprosthesis infection, and/or nonunion (or necrosis) of surgical incision occurred.

Design outcomes

Primary

MeasureTime frame
Hospital anxiety and depression scale;Perioperative Anxiety Scale-7;Visual analog scale for anxiety;Single Item Overall Patient Satisfaction Questionnaire;

Secondary

MeasureTime frame
Western Ontario and McMaster Universities Osteoarthritis Index;Visual analogue scale for pain;

Countries

China

Contacts

Public ContactXiaofei Zheng

The First Hospital of Jinan University

zhengxiaofei12@163.com+86 138 8990 4898

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026