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

NCT07544264 | Not Yet Recruiting

• 1 other identifier: ALLPOLY-TKA
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Implant failure

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

  Up to 5 years post-surgery

Secondary Outcomes (5)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Up to 5 years post-surgery

• Forgotten Joint Score (FJS)

  Up to 5 years post-surgery

• Visual Analog Scale (VAS) pain

  Up to 5 years post-surgery

• VAS Satisfaction

  Up to 5 years post-surgery

• Hip-Knee-Ankle angle (HKA)

  Up to 5 years post-surgery

Study Arms (1)

TKA

EXPERIMENTAL

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

Device: Total knee arthroplasty

Interventions

Total knee arthroplasty DEVICE

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

TKA

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Rizzoli Orthopedic Institute

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

stefano zaffagnini

CONTACT

0516366075; stefano.zaffagnini@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2032
• Study Completion (Estimated): October 1, 2032
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

IT (1)