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

NCT07544264 · tracked via the Priya Life Science Italy tracker

Sponsor

Istituto Ortopedico Rizzoli

Phase

Not applicable

Started

2026-05-13

Last updated

2026-06-23

Condition(s) studied

Prosthesis SurvivalArthropathy of Knee

Investigational drug(s) / intervention(s)

Total knee arthroplasty

Total knee arthroplasty: Implantation of the Link Symphoknee prosthesis with an all-polyethylene tibial component

Study summary

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 Link Symphoknee prosthesis with an all-polyethylene tibial component, along with clinical-functional outcomes and post-discharge readmission rates in patients treated at the Rizzoli Orthopaedic Institute.

Eligibility

Sex

ALL

Min age

50 Years

Max age

85 Years

Healthy volunteers

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.

Primary outcome measure(s)

Implant failure — Up to 5 years post-surgery
It is defined as revision of the prosthesis for any reason-septic, aseptic, or traumatic.

Trial sites (1)

Facility	City	Region	Status
IRCCS Rizzoli Orthopedic Institute	Bologna	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07544264 on ClinicalTrials.gov ↗ ← All trials in Italy