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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-78
SponsorIstituto Ortopedico Rizzoli

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: DIG-PROMs-kOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month before surgery (pre-admission outpatient visit)
2

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.

Time frame
1 month after surgery (follow up visit)
3

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.

Time frame
3 months after surgery (follow up visit)
4

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.

Time frame
6 months after surgery (follow up visit)

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

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.

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

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.

Time frame
1 month after surgery (follow up visit)
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

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.

Time frame
3 months after surgery (follow up visit)
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

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.

Time frame
6 months after surgery (follow up visit)

Other outcomes

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