An interventional study of Total knee arthroplasty in Prosthesis Survival and Arthropathy of Knee, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
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.
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's planned enrollment of 78 is above the median of 36 across 69 interventional studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
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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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implantation of the Link Symphoknee prosthesis with an all-polyethylene tibial component.
Device: Total knee arthroplasty
Implantation of the Link Symphoknee prosthesis with an all-polyethylene tibial component
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
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
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
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
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
Hip-Knee-Ankle angle (HKA)
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
Time frame: Up to 5 years post-surgery
Started May 2026 (actual). Primary completion is estimated for Oct 2032, 77 months after the start.
Of 48 non-industry interventional studies with no phase under Prosthesis Failure, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 77 months is above that.
Counting every sponsor, half of 50 studies reached it within 18 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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