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NCT Number: NCT07544264

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

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.

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Key information

Conditions

Prosthesis Survival Arthropathy of Knee Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Rizzoli Orthopedic Institute

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Stefano Zaffagnini

CONTACT

[email protected]

0516366075

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:
  • 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.
  • Patients who sign the informed consent approved by the Ethics Committee.

Exclusion criteria

  • 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.

Treatment and study plan

Total knee arthroplasty

Device

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

Primary outcomes

  1. Implant failure

    Time frame: Up to 5 years post-surgery

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

Secondary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Up to 5 years post-surgery

    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.

  2. Forgotten Joint Score (FJS)

    Time frame: Up to 5 years post-surgery

    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

  3. Visual Analog Scale (VAS) pain

    Time frame: Up to 5 years post-surgery

    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

  4. VAS Satisfaction

    Time frame: Up to 5 years post-surgery

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

  5. Hip-Knee-Ankle angle (HKA)

    Time frame: Up to 5 years post-surgery

    It is the angle that measures the mechanical alignment of the lower limb, drawn between the hip, knee, and ankle axes on a weight-bearing radiograph. It is used to assess whether the leg is neutrally aligned or shows varus or valgus deformity

Study contacts

Contact information is provided by the study sponsor or research team.

stefano zaffagnini

CONTACT

[email protected]

0516366075

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: ALLPOLY-TKA

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Apr 22, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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