Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Duration - Day of surgery
Participants undergo knee arthroplasty surgery as part of their treatment for gonarthrosis.
Surgery visit
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
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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