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NCT Number: NCT04752761

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

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.

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Key information

Conditions

Approach-Approach Conflict Knee Discomfort

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 1 month before surgery (pre-admission outpatient 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.

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

    Time frame: 1 month after surgery (follow up 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 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. Patient's adhesion to the digital Oxford Knee Score compilation three months after surgery

    Time frame: 3 months after surgery (follow up 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 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.

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

    Time frame: 6 months after surgery (follow up 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 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.

Secondary outcomes

  1. 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

    Time frame: 1 month before surgery (pre-admission outpatient visit)

    As a secondary end point, the level of coherence between the Oxford Knee Score detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration will be examined, one month before surgery, on the occasion of the pre-admission visit.

    Which and how many responses will be discordant with respect to the two types of survey will be indicated.

  2. 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

    Time frame: 1 month after surgery (follow up visit)

    As a secondary end point, the level of coherence between the Oxfor Knee Score detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration will be examined, one month after surgery, on the occasion of the follow up visit.

    Which and how many responses will be discordant with respect to the two types of survey will be indicated.

  3. 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

    Time frame: 3 months after surgery (follow up visit)

    As a secondary end point, the level of coherence between the Oxford Knee Score detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration will be examined, three months after surgery, on the occasion of the follow up visit.

    Which and how many responses will be discordant with respect to the two types of survey will be indicated.

  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 six months after surgery

    Time frame: 6 months after surgery (follow up visit)

    As a secondary end point, the level of coherence between the Oxford Knee Score detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration will be examined, six months after surgery, on the occasion of the follow up visit.

    Which and how many responses will be discordant with respect to the two types of survey will be indicated.

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Di Sante

CONTACT

[email protected]

+393286491562

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Compliance al Rilevamento PROMs Mediante Supporto Digitale e Correlazione Rispetto Alla Rilevazione Ambulatoriale Nella Protesica di Ginocchio

Acronym: DIG-PROMs-k

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2021
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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