MedTrace Logo

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

NCT07544264 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-04-22

No results posted yet for this 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.

Conditions

  • Prosthesis Survival
  • Arthropathy of Knee

Interventions

DEVICE

Total knee arthroplasty

Implantation of the Link Symphoknee prosthesis with an all-polyethylene tibial component

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2032-10-31
Completion
2032-10-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07544264 on ClinicalTrials.gov