Comparing digital and paper methods for assessing knee prosthetic outcomes
Compliance al Rilevamento PROMs Mediante Supporto Digitale e Correlazione Rispetto Alla Rilevazione Ambulatoriale Nella Protesica di Ginocchio
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 78 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna, Italia) |
| Trial ID | NCT04752761 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using digital methods for patient-reported outcomes, suggesting this approach may be effective.
Eligibility criteria
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 this trial is running
Bologna, Italia
- Istituto Ortopedico Rizzoli — Bologna, Italia, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppe Di Sante
- Email: giusebbeds@hotmail.it
- Phone: +393286491562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.