Osteoarthritis (OA) of the Knee
Conditions
Keywords
Total Knee Arthroplasty, Conversational assistant, Patient Satisfaction, Artificial Intelligence, Digital Health
Brief summary
Total knee arthroplasty (TKA) is one of the most frequently performed elective orthopaedic procedures. Following hospital discharge, patients must manage pain, wound care and home rehabilitation with limited professional support. This pragmatic randomised pilot trial will evaluate whether a web-based conversational postoperative assistant, used in addition to standard care, improves patient satisfaction and exercise adherence during the first 6 weeks after TKA. Forty to sixty patients undergoing primary elective TKA will be randomised 1:1 to standard care with or without access to the conversational assistant. The primary outcome is overall patient satisfaction at 6 weeks. Secondary outcomes include pain intensity, exercise adherence, unplanned healthcare contacts and postoperative complications.
Detailed description
This single-centre pragmatic randomized pilot trial will evaluate the feasibility and preliminary effectiveness of a web-based conversational postoperative assistant following primary total knee arthroplasty (TKA). Participants will be randomized in a 1:1 ratio to receive either standard postoperative care alone or standard care plus access to the conversational assistant for 6 weeks after surgery. The assistant provides evidence-based postoperative education, recovery guidance, answers to common patient questions, and safety-oriented recommendations. The primary outcome is overall patient satisfaction at 6 weeks. Secondary outcomes include pain intensity, exercise adherence, unplanned healthcare contacts, and postoperative complications. The study is designed to generate preliminary evidence to support the development of a larger definitive randomized controlled trial.
Interventions
BEHAVIORALWeb-based conversational postoperative assistant
Participants assigned to the intervention group receive access to a web-based conversational assistant for 6 weeks after primary total knee arthroplasty. The assistant provides evidence-based postoperative education, recovery guidance, answers to common patient questions, and safety-oriented recommendations. It is available on demand and complements, but does not replace, standard postoperative care.
Sponsors
Wojciech Sroga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This is an open-label study. Participants and investigators are aware of the assigned intervention.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to receive either standard postoperative care plus access to a web-based conversational assistant or standard postoperative care alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Primary, unilateral, elective total knee arthroplasty (TKA). * Discharged to home following surgery. * Ability to use a smartphone or tablet with internet access (patient or caregiver). * Written informed consent provided.
Exclusion criteria
* Revision or bilateral simultaneous TKA. * Major postoperative complication precluding home discharge (e.g., admission to intensive care, unplanned return to theatre, or haemodynamic instability). * Severe cognitive impairment precluding informed consent or device use. * No access to an internet-enabled device. * Inability or refusal to complete follow-up. * Participation in another interventional study at enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Patient Satisfaction | 6 weeks after total knee arthroplasty | Overall patient satisfaction measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates not satisfied at all and 10 indicates completely satisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 2 weeks and 6 weeks after total knee arthroplasty | Pain intensity measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. |
| Exercise Adherence | During the first 6 weeks after total knee arthroplasty | Exercise adherence assessed as the percentage of prescribed home exercise sessions completed, based on the participant's exercise diary. |
| Unplanned Healthcare Contacts | During the first 6 weeks after total knee arthroplasty | Number of unplanned healthcare contacts related to the operated knee, including primary care visits, emergency department visits, outpatient consultations, and hospital readmissions. |
| Postoperative Complications | During the first 6 weeks after total knee arthroplasty | Occurrence of postoperative complications related to the surgical procedure. |
Countries
Spain
Outcome results
None listed