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Clinical trial Recruiting at 1 site Interventional Ages 18 to 78

Comparing digital and paper methods for assessing knee prosthetic outcomes

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

Run by Istituto Ortopedico Rizzoli · NCT04752761 · Data updated 2026-11-12

This study is testing whether using digital questionnaires on smartphones or traditional paper forms is better for understanding how patients feel after knee replacement surgery.

Quick facts

Study typeInterventional
Ages18 Years to 78 Years
SexAll
Enrollment50 (estimated)
SponsorIstituto Ortopedico Rizzoli
Academic / other
Locations1 site (Bologna, Italia)
StatusRecruiting
StartedNovember 30, 2020
Main results expectedDecember 1, 2027
Study endsDecember 31, 2027
Registry record updatedMay 26, 2026
Trial IDNCT04752761 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include males and females aged 18-78 with gonarthrosis who have a Barthel scale score of 91 or higher and access to digital devices.

Probably not a fit

Patients with significant psychiatric issues, a history of substance abuse, or those lacking access to digital devices may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares two methods for evaluating patient-reported outcomes after knee prosthetic surgery: traditional paper questionnaires administered in an outpatient setting versus digital questionnaires sent to patients' smartphones. The aim is to assess the validity and compliance of these methods using the Oxford Knee Score, which measures knee discomfort. Patients will complete the questionnaires during pre-hospitalization visits and follow-ups at 1, 3, and 6 months post-surgery. The study will analyze differences in patient satisfaction and compliance between the two methods.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy and convenience of outcome assessments for knee prosthetic surgeries, leading to better patient care.

How similar studies have gone: Other studies have shown promise in using digital methods for patient-reported outcomes, suggesting this approach may be effective.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Istituto Ortopedico Rizzoli
    Bologna, Italia, Italy     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.