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Not yet recruiting NCT07731815

Web-Based Conversational Assistant After Total Knee Arthroplasty

No phase Interventional Osteoarthritis (OA) of the Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Web-based conversational postoperative assistant.
Who it may be relevant to
Registry conditions: Osteoarthritis (OA) of the Knee. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

  • Behavioral Web-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.

Primary outcome measures

  • Overall Patient Satisfaction [Time frame: 6 weeks after total knee arthroplasty]
Secondary outcome measures (4)
  • Pain Intensity [Time frame: 2 weeks and 6 weeks after total knee arthroplasty]
  • Exercise Adherence [Time frame: During the first 6 weeks after total knee arthroplasty]
  • Unplanned Healthcare Contacts [Time frame: During the first 6 weeks after total knee arthroplasty]
  • Postoperative Complications [Time frame: During the first 6 weeks after total knee arthroplasty]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Spain · 1 center
  • Hospital Universitario Virgen de los Lirios — Alcoy

Identifiers

NCT: NCT07731815 · HGUVL-TKA-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗