Actively Recruiting

Phase Not Applicable
Age: 18Years - 78Years
All Genders
ID04752761

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

Led by Istituto Ortopedico Rizzoli · Updated on 2026-05-26

50

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two methods for detecting patient outcomes after knee prosthetic surgery. The study evaluates the traditional paper questionnaire method using the Oxford Knee Score in outpatient settings versus a digital questionnaire delivered via Google Forms to patients' smartphones. The goal is to validate whether the digital method is a reliable alternative for assessing patient-reported outcomes measures (PROMs) related to knee arthrosis discomfort. Patients will complete the Oxford Knee Score questionnaire both on paper during outpatient visits and digitally through Google Forms sent to their devices. The questionnaires are administered during pre-hospitalization and follow-up visits at 1, 3, and 6 months after surgery. The digital responses must be completed within 48 hours of the outpatient visit to be considered valid. The study will compare patients' adherence and satisfaction with both methods and analyze any differences in knee score results and outpatient assessment times. Participants will be evaluated at multiple time points starting one month before surgery through six months post-operation. Researchers will monitor patient adherence to the digital questionnaire after each visit and assess the consistency between the paper and digital Oxford Knee Score results. The study also tracks the time needed for outpatient assessments. Overall participant involvement includes completing questionnaires and attending scheduled follow-up visits, with the study lasting at least six months after surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 78Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with gonarthrosis indicated for knee arthroplasty
  • Male or female participants aged 18 to 78 years
  • Barthel scale score of 91 or higher
  • Access to a personal digital device such as a smartphone, tablet, or computer
Not Eligible

You will not qualify if you...

  • Barthel scale score of 90 or lower
  • History of psychiatric disorders, drug, or alcohol abuse
  • No access to a personal digital device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Evaluation

Duration - 1 month before surgery

Participants complete the Oxford Knee Score questionnaire both through conventional paper methods during pre-admission outpatient visits and via a digital method using Google Forms outside the outpatient setting.

1 pre-admission outpatient visit

Surgery

Duration - Day of surgery

Participants undergo knee arthroplasty surgery as part of their treatment for gonarthrosis.

Surgery visit

Post-surgery Follow-up

Duration - 6 months after surgery

Participants complete the Oxford Knee Score questionnaire both via conventional paper methods during outpatient follow-up visits and via digital methods outside the outpatient setting at 1, 3, and 6 months after surgery to evaluate compliance and satisfaction with both methods.

Follow-up visits at 1, 3, and 6 months (in-person)

Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzoli

Bologna, Italia, Italy, 40136

Actively Recruiting

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Research Team

G

Giuseppe Di Sante

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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