NCT07731815

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 23, 2026

Last Update Submit

July 23, 2026

Conditions

Keywords

Total Knee ArthroplastyConversational assistantPatient SatisfactionArtificial IntelligenceDigital Health

Outcome Measures

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.

    6 weeks after total knee arthroplasty

Secondary Outcomes (4)

  • Pain Intensity

    2 weeks and 6 weeks after total knee arthroplasty

  • Exercise Adherence

    During the first 6 weeks after total knee arthroplasty

  • Unplanned Healthcare Contacts

    During the first 6 weeks after total knee arthroplasty

  • Postoperative Complications

    During the first 6 weeks after total knee arthroplasty

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen de los Lirios

Alcoy, Alicante, 03803, Spain

Location

MeSH Terms

Conditions

OsteoarthritisPatient Satisfaction

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Participants and investigators are aware of the assigned intervention.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 28, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07

Locations