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NCT Number: NCT07731815

Web-Based Conversational Assistant After Total Knee Arthroplasty

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.

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Key information

Conditions

Osteoarthritis (OA) of the Knee Arthritis Behavior Health Behavior Joint Diseases Musculoskeletal Diseases Osteoarthritis Patient Satisfaction Rheumatic Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Web-based conversational postoperative assistant

Behavioral

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.

Primary outcomes

  1. Overall Patient Satisfaction

    Time frame: 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 outcomes

  1. Pain Intensity

    Time frame: 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.

  2. Exercise Adherence

    Time frame: 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.

  3. Unplanned Healthcare Contacts

    Time frame: 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.

  4. Postoperative Complications

    Time frame: During the first 6 weeks after total knee arthroplasty

    Occurrence of postoperative complications related to the surgical procedure.

Sponsors and collaborators

Lead sponsor

Wojciech Sroga

Other

Registry information

Official study title

Evaluation of a Web-Based Conversational Postoperative Assistant on Patient Satisfaction and Exercise Adherence After Total Knee Arthroplasty: Protocol of a Pragmatic Randomized Pilot Study With 6-Week Follow-up

Acronym: CARE-TKA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

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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