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Clinical Trials in Italy / NCT04752761
Recruiting Not applicable

Compliance With PROMs Detection Through Digital Support and Correlation Compared Standard to Outpatient Detection in Knee Prosthetics

NCT04752761 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Not applicable
Started
2020-11-30
Last updated
2026-05-26

Condition(s) studied

Approach-Approach ConflictKnee Discomfort

Investigational drug(s) / intervention(s)

Extrambulatory digital PROMs detection

Extrambulatory digital PROMs detection: An alternative PROMs evaluation method will be used in which the questionnaire will be administered to the patient digitally (Google Forms) in an outpatient environment

Study summary

Two methods for detecting outcomes after knee prosthetic surgery are compared: the traditional one using paper questionnaires administered in the outpatient setting (Oxford Knee Score) VS detection using digital questionnaires created on Google Forms and sent to the patient's smartphone on which the compilation takes place in the extra area outpatient.

Eligibility

Sex
ALL
Min age
18 Years
Max age
78 Years
Healthy volunteers
No
Inclusion Criteria: * patients with gonarthrosis with indication of hip arthroplasty * males and females aged 18-78 and with a Barthel scale score ≥ 91 * patients in possession of private digital electronic support (smartphone, tablet or PC) Exclusion criteria: * patients with a Barthel scale score ≤ 90 * patients with psychiatric pathologies, a history of drug and alcohol abuse * patients not in possession of private digital electronic support

Primary outcome measure(s)

  • Patient's adhesion to the digital Oxford Knee Score compilation after the pre-admission visit — 1 month before surgery (pre-admission outpatient visit)
    Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the OKS index compared to the conventional one. Those who complete the questionnaire within 48 hours of the outpatient visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.
  • Patient's adhesion to the digital Oxford Knee Score compilation one month after surgery — 1 month after surgery (follow up visit)
    Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the OKS index compared to the conventional one. Those who complete the questionnaire within 48 hours of the follow up visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.
  • Patient's adhesion to the digital Oxford Knee Score compilation three months after surgery — 3 months after surgery (follow up visit)
    Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the OKS index compared to the conventional one. Those who complete the questionnaire within 48 hours of the follow up visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.
  • Patient's adhesion to the digital Oxfor Knee Score compilation six months after surgery — 6 months after surgery (follow up visit)
    Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the OKS index compared to the conventional one. Those who complete the questionnaire within 48 hours of the follow up visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.

Trial sites (1)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna Italia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04752761 on ClinicalTrials.gov ↗ ← All trials in Italy