Evaluating knee prosthesis outcomes using inertial sensors
Official title: Evaluation of the Clinical Outcomes of the Total Knee Prosthesis With Posterior Stabilization Implanted With the Use of Inertial Sensors
Run by Istituto Ortopedico Rizzoli · NCT06321042 · Data updated 2026-11-12
This study is testing if using special sensors during knee replacement surgery helps people aged 50 to 85 feel better and move easier afterward.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 50 Years to 85 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna, Italia) |
| Status | Recruiting |
| Started | January 13, 2023 |
| Main results expected | January 2027 |
| Study ends | March 2027 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT06321042 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males and females aged 50 to 85 who require primary total knee replacement due to severe knee pain and disability.
✕Probably not a fit
Patients who have previously undergone hip or ankle arthroplasty or those unable to provide informed consent 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 evaluates the clinical outcomes of a specific total knee arthroplasty (TKA) model implanted with the assistance of inertial sensors. The approach involves using these sensors to guide bone cuts during surgery, aiming to improve the precision of the procedure. Clinical-functional scores will be calculated through patient questionnaires to assess the effectiveness of the implantation. The study focuses on patients aged 50 to 85 who are candidates for primary cemented total knee replacement due to severe knee pain and disability.
Why it matters
Potential benefit: If successful, this study could lead to improved durability and functionality of knee prostheses for patients.
How similar studies have gone: While the use of inertial sensors in surgical procedures is an emerging field, similar studies have shown promise in improving surgical outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female subjects 50 years of age or older and less than 85 years of age (\>50 and \<85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes: * to. Primary or secondary osteoarthritis * b. Collagen disorders and/or avascular necrosis of femoral condyle * c. Moderate valgus, varus or flexion deformities (HKA between ± 10°, flexion contracture \<10°) - 2. Patients consent and able to complete scheduled study procedures and follow-up assessments. 3. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee. Exclusion Criteria: * Simultaneous participation in other studies * Patients not capable of understanding and wanting and therefore unable to sign the informed consent * Patients who have already undergone hip or ankle arthroplasty, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases.
Where it's running
-
Stefano Zaffagnini
Bologna, Italia, Italy Recruiting
Study contacts
- Study coordinator: Stefano Zaffagnini, Prof
- Email: stefano.zaffagnini@unibo.it
- Phone: 0516366075
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.