Total knee replacement with a polyethylene tibial component to see how long it lasts and how patients do

Is this trial a fit for you?

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

What this trial studies

This interventional study evaluates the durability and clinical outcomes of total knee arthroplasty using a polyethylene tibial component. Eligible adults aged 50–85 with severe knee pain and disability due to osteoarthritis or related conditions are enrolled and undergo cemented primary TKA. Participants are followed over five years to assess implant survival, functional outcomes, and patient-reported measures. The study aims to determine if the all-polyethylene tibial design can provide good longevity, reduced costs, and satisfactory joint function. No comparative arm is described in the available information.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female subjects aged ≥50 and ≤85 years who are candidates for primary cemented total knee arthroplasty based on physical examination and medical history, including a diagnosis of severe knee pain and disability due to at least one of the following conditions:

   1. Primary or secondary osteoarthritis
   2. Collagen disorders and/or avascular necrosis of the femoral condyle
   3. Moderate valgus, varus, or flexion deformities (Hip-Knee-Ankle angle within ±15°).
2. Patients who provide consent and are able to complete the scheduled study procedures and follow-up assessments.
3. Patients who sign the informed consent approved by the Ethics Committee.

Exclusion Criteria:

1. Patients under 50 years of age and over 85 years of age;
2. Diagnosis of rheumatoid arthritis;
3. Patients with a contralateral joint prosthesis on the same side;
4. Coronal plane deformity with a Hip-Knee-Ankle (HKA) angle greater than 15 degrees in varus or valgus.

Where it's running

• IRCCS Rizzoli Orthopedic Institute
  Bologna, Italy Recruiting

Study contacts

• Study coordinator: stefano zaffagnini
• Email: stefano.zaffagnini@unibo.it
• Phone: 0516366075

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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.