Compliance With PROMs Detection Through Digital Support and Correlation Compared Standard to Outpatient Detection in Knee Prosthetics (DIG-PROMs-k)

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Approach-Approach Conflict; Knee Discomfort

Treatments: Behavioral: Extrambulatory digital PROMs detection

Study type: Interventional

Funder types: Other

Identifiers

NCT04752761

CE-AVEC 584/2020 / Oss / IOR

Details and patient eligibility

About

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.

Full description

PROMs (Patient Reported Outcomes Measures) are used globally for the evaluation of the results of a prosthetic surgery. One of the most used methods in the evaluation of PROMs in knee prosthetic surgery is the Oxford Knee Score, usually measured in an outpatient setting using paper questionnaires.

The aim of the study is to investigate the validity of an alternative method of evaluating PROMs in which the questionnaire will be administered to the patient digitally (Google Forms) in an out-of-patient setting.

The questionnaire aimed at the subjective evaluation of the discomfort induced by arthrosis of the knee (Oxford Knee Score), will be administered during the pre-hospitalization visits and again during the follow-up visits carried out at 1, 3 and 6 months after intervention. The digital evaluation will be sent to the patient during the outpatient visits and will be considered valid only if completed within 48 hours of the same.

On each patient the measurements will be carried out in both methods and differences in terms of compliance and satisfaction with the two methods under examination will be detected. Any differences in the final result of the Oxford Knee Score compared to the two methods and the differences in terms of outpatient assessment times will also be evaluated.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

DIG-PROMs-k

Other group

Description:

Patients who underwent TKA are given conventional and digital OKS surveys. Patients adhesion to both surveys will be compared.

Treatment:

Behavioral: Extrambulatory digital PROMs detection