Knee implant survival check: will new plastic design outperform the old?

NCT ID NCT07544264

Knowledge-focused Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow 78 people aged 50 to 85 who need a total knee replacement to see how well a newer all-polyethylene (plastic) knee implant holds up over 5 years. Researchers want to know if this design, which may be cheaper and have fewer mechanical problems, works as well as or better than standard metal-backed implants. The main goal is to track how many implants fail and need to be replaced.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee Prosthesis Failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthropathy of knee Prosthesis survival

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Knee implant survival check: will new plastic design outperform the old?

What the study statuses mean