Prosthesis SurvivalALLPOLY-TKANCT07544264
Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component
A study testing Total knee arthroplasty in people with Prosthesis Survival and Arthropathy of Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Prosthesis Survival, Arthropathy of Knee
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2026to Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Rizzoli Orthopedic Institute
Bologna, 40136
Stefano Zaffagnini, 0516366075, stefano.zaffagnini@ior.it
About this study
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.
Read more
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
- Being tested
- Total knee arthroplasty
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyDevice
Implantation of the Link Symphoknee prosthesis with an all-polyethylene tibial component
| Study group | Role | What they receive |
|---|---|---|
| TKA | Experimental | Implantation of the Link Symphoknee prosthesis with an all-polyethylene tibial component. Receives: Device: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant failure
It is defined as revision of the prosthesis for any reason-septic, aseptic, or traumatic.
Measured: Up to 5 years post-surgery
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start13 May 2026
- Primary completionOct 2032 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis SurvivalStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544264
- Sponsor's protocol ID
- ALLPOLY-TKA
- Acronym
- ALLPOLY-TKA
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component
- ClinicalTrials.gov ID
- NCT07544264
- Acronym / sponsor ID
- ALLPOLY-TKA / ALLPOLY-TKA
- Conditions
- Prosthesis Survival, Arthropathy of Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- Oct 2032 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKA | Experimental | Device: Total knee arthroplastyImplantation of the Link Symphoknee prosthesis with an all-polyethylene tibial component. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplastyImplantation of the Link Symphoknee prosthesis with an all-polyethylene tibial component | Device | TKA |
Primary outcome
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.
5 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Up to 5 years post-surgery
Forgotten Joint Score (FJS)
Time frame: Up to 5 years post-surgery
Visual Analog Scale (VAS) pain
Time frame: Up to 5 years post-surgery
VAS Satisfaction
Time frame: Up to 5 years post-surgery
Hip-Knee-Ankle angle (HKA)
Time frame: Up to 5 years post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty in people with Prosthesis Survival and Arthropathy of Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact stefano zaffagnini (0516366075, stefano.zaffagnini@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant failure (time frame: Up to 5 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.