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

NCT04752761 | Recruiting

• 1 other identifier: CE-AVEC 584/2020 / Oss / IOR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Approach-Approach Conflict; Knee Discomfort

Keywords

PROMs; Digital; Knee prosthesis; Oxford knee score

Outcome Measures

Primary Outcomes (4)

• Patient's adhesion to the digital Oxford Knee Score compilation after the pre-admission 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.

  1 month before surgery (pre-admission outpatient visit)

• Patient's adhesion to the digital Oxford Knee Score compilation one month after surgery

  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.

  1 month after surgery (follow up visit)

• Patient's adhesion to the digital Oxford Knee Score compilation three months after surgery

  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.

  3 months after surgery (follow up visit)

• Patient's adhesion to the digital Oxfor Knee Score compilation six months after surgery

  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.

  6 months after surgery (follow up visit)

Secondary Outcomes (4)

• 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

  1 month before surgery (pre-admission outpatient visit)

• 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

  1 month after surgery (follow up visit)

• 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

  3 months after surgery (follow up visit)

• 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

  6 months after surgery (follow up visit)

Study Arms (1)

DIG-PROMs-k

OTHER

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

Behavioral: Extrambulatory digital PROMs detection

Interventions

Extrambulatory digital PROMs detection BEHAVIORAL

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

DIG-PROMs-k

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Italia, 40136, Italy

RECRUITING

Central Study Contacts

Giuseppe Di Sante

CONTACT

+393286491562; giusebbeds@hotmail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: February 12, 2021
• Study Start: November 30, 2020
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

IT (1)