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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorIstituto Ortopedico Rizzoli

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Primary or secondary osteoarthritis

Collagen disorders and/or avascular necrosis of the femoral condyle

Moderate valgus, varus, or flexion deformities (Hip-Knee-Ankle angle within ±15°).

Patients who provide consent and are able to complete the scheduled study procedures and follow-up assessments.

Disqualifiers

Patients under 50 years of age and over 85 years of age;

Diagnosis of rheumatoid arthritis;

Patients with a contralateral joint prosthesis on the same side;

Coronal plane deformity with a Hip-Knee-Ankle (HKA) angle greater than 15 degrees in varus or valgus.

Trial design

Design model

Single group

Treatments tested in this trial

  • Total knee arthroplasty

    Device

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

Treatment groups

78 Participants
are divided into 1 treatment group
Group A: TKAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Implant failure

It is defined as revision of the prosthesis for any reason-septic, aseptic, or traumatic.

Time frame
Up to 5 years post-surgery

Secondary outcomes

1

Knee injury and Osteoarthritis Outcome Score (KOOS)

It is a subjective score consisting of 42 questions divided into 5 main domains. These domains assess different aspects of symptoms and daily activities, as well as knee-related quality of life.

Time frame
Up to 5 years post-surgery
2

Forgotten Joint Score (FJS)

The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure consisting of 12 questions that assesses how frequently a patient forgets they have a joint prosthesis during daily activities. It measures the patient's perception of the artificial joint rather than pain or function alone, with higher scores (0-100) indicating better "forgetting" of the joint

Time frame
Up to 5 years post-surgery
3

Visual Analog Scale (VAS) pain

A 10-point unidimensional visual analog scale (VAS) for pain assessment, consisting of a 10 cm horizontal line ranging from "no pain" (0) to "worst imaginable pain" (10). The patient marks their perceived pain intensity on the line, and the distance from zero is measured to quantify pain. It is also used pre- and post-operatively to assess lateral knee pain; a score \>2 is considered the presence of lateral compartment pain, while ≤2 indicates its absence

Time frame
Up to 5 years post-surgery
4

VAS Satisfaction

Intraoperative and postoperative complications will be recorded. Any hospital readmissions within 90 days of discharge after the arthroplasty procedure will also be documented

Time frame
Up to 5 years post-surgery

Other outcomes

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