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Study identifier: NCT07544264 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component

Condition: Prosthesis Survival · Arthropathy of Knee  ·  Sponsor: Istituto Ortopedico Rizzoli

PhaseNA
Planned participants78
Who can joinAll sexes, 50 Years to 85 Years
Healthy volunteersNo

About this study

Total knee arthroplasty (TKA) is one of the most successful procedures in orthopedic surgery for treating advanced knee osteoarthritis, providing pain relief, functional recovery, and improved quality of life. Advances in implant design and materials have further enhanced joint kinematics and patient satisfaction. An aging population has increased the number of elderly patients with comorbidities, potentially affecting surgical outcomes and implant longevity. Polyethylene has long been used in knee prostheses; early all-polyethylene tibial components were abandoned due to high wear and failure rates, in favor of metal-backed designs, which became the gold standard. Recently, highly cross-linked ultra-high-molecular-weight polyethylene (UHMWPE) has renewed interest in all-polyethylene tibial components, although their use remains limited. These implants offer potential advantages, including elimination of locking mechanism failures, reduced backside wear, lower costs, and possibly better load distribution. Evidence from registries, systematic reviews, and meta-analyses shows that 15-year survival of all-polyethylene tibial components is comparable or even superior to metal-backed designs, with no significant differences in clinical-functional outcomes. Additionally, all-poly components are significantly less expensive. Given these findings, increasing their use and evaluating outcomes in Italy is warranted. The aim of the present study is to assess implant survival of the …

This description comes directly from the study's public registry record.

Talk to the study team

stefano zaffagnini  ·  0516366075  ·  stefano.zaffagnini@unibo.it

Always discuss trial participation with your own doctor first.

Locations (1)

IRCCS Rizzoli Orthopedic InstituteBologna, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07544264