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Not yet recruitingNCT07731815CARE-TKAUpdated Jul 28, 2026

Web-Based Conversational Assistant After Total Knee Arthroplasty

An interventional study of Web-based conversational postoperative assistant in Osteoarthritis (OA) of the Knee, sponsored by Wojciech Sroga. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Wojciech Sroga · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis (OA) of the Knee

Keywords

  • Total Knee Arthroplasty
  • Conversational assistant
  • Patient Satisfaction
  • Artificial Intelligence
  • Digital Health
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

This is the only study on the registry with Wojciech Sroga as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Intervention

    Participants receive standard postoperative care plus access to a web-based conversational postoperative assistant for 6 weeks after primary total knee arthroplasty.

    Behavioral: Web-based conversational postoperative assistant

  • No intervention
    Control

    Participants receive standard postoperative care without access to the web-based conversational postoperative assistant.

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.

06

What researchers measure

Primary outcomes

  1. Overall Patient Satisfaction

    Overall patient satisfaction measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates not satisfied at all and 10 indicates completely satisfied.

    Time frame: 6 weeks after total knee arthroplasty

Secondary outcomes

  1. Pain Intensity

    Pain intensity measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Time frame: 2 weeks and 6 weeks after total knee arthroplasty

  2. Exercise Adherence

    Exercise adherence assessed as the percentage of prescribed home exercise sessions completed, based on the participant's exercise diary.

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

  3. Unplanned Healthcare Contacts

    Number of unplanned healthcare contacts related to the operated knee, including primary care visits, emergency department visits, outpatient consultations, and hospital readmissions.

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

  4. Postoperative Complications

    Occurrence of postoperative complications related to the surgical procedure.

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

07

Study locations

1 site
  • Hospital Universitario Virgen de los Lirios
    Alcoy, Alicante 03803, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07731815
Lead sponsor
Wojciech Sroga
Responsible party
Wojciech Sroga (Principal Investigator, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana) — Sponsor-investigator
First posted
Jul 28, 2026
Start date
Oct 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jul 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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