Clinical trial NCT04752761: Compliance With PROMs Detection Through Digital Support and Correlation Compared Standard to Outpatient Detection in Knee Prosthetics
Official title: Compliance al Rilevamento PROMs Mediante Supporto Digitale e Correlazione Rispetto Alla Rilevazione Ambulatoriale Nella Protesica di Ginocchio
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Approach-Approach Conflict
Knee Discomfort
Keywords: PROMs
Digital
Knee prosthesis
Oxford knee score
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Patient's adhesion to the digital Oxford Knee Score compilation after the pre-admission visit
timeFrame: 1 month before surgery (pre-admission outpatient visit)
measure: Patient's adhesion to the digital Oxford Knee Score compilation one month after surgery
timeFrame: 1 month after surgery (follow up visit)
measure: Patient's adhesion to the digital Oxford Knee Score compilation three months after surgery
timeFrame: 3 months after surgery (follow up visit)
measure: Patient's adhesion to the digital Oxfor Knee Score compilation six months after surgery
timeFrame: 6 months after surgery (follow up visit)
Secondary outcomes:
measure: Level of coherence between the OKS detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration one month before surgery
timeFrame: 1 month before surgery (pre-admission outpatient visit)
measure: Level of coherence between the OKS detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration one month after surgery
timeFrame: 1 month after surgery (follow up visit)
measure: Level of coherence between the OKS detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration threee months after surgery
timeFrame: 3 months after surgery (follow up visit)
measure: Level of coherence between the OKS detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration six months after surgery
timeFrame: 6 months after surgery (follow up visit)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: Italia
Study officials:
References: