Prosthesis DurabilitySYMPHO-EMNCT06321042
Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors
An observational study of Prosthesis Durability, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores; Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- Knee arthroplasty
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jan 2023to Mar 2027
- Phase
- Observational
- 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
Study population: Patients candidates to TKA surgery
Who may be able to join
- Male and female subjects 50 years of age or older and less than 85 years of age (>50 and <85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes:
- to. Primary or secondary osteoarthritis
- b. Collagen disorders and/or avascular necrosis of femoral condyle
- c. Moderate valgus, varus or flexion deformities (HKA between ± 10°, flexion contracture <10°) -
- Patients consent and able to complete scheduled study procedures and follow-up assessments.
- Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.
Who cannot join
- Simultaneous participation in other studies
- Patients not capable of understanding and wanting and therefore unable to sign the informed consent
- Patients who have already undergone hip or ankle arthroplasty, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases.
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
Stefano Zaffagnini
Bologna, Italia
Stefano Zaffagnini, MD, 051 6366075, stefano.zaffagnini@unibo.it
About this study
Official title: Evaluation of the Clinical Outcomes of the Total Knee Prosthesis With Posterior Stabilization Implanted With the Use of Inertial Sensors
evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;
- Conditions
- Prosthesis Durability
- Being tested
- 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.
Knee arthroplastyDevice
Knee arthroplasty surgery with perseus orthokey alignment device
| Study group | Role | What they receive |
|---|---|---|
| Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device | Not described Receives: Device: Knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Measured: at baseline (day 0)
Knee Society Score
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Measured: 6 months
Knee Society Score
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Measured: 12 months
Knee Society Score
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Measured: 24 months
Western Ontario and McMaster Universities Arthritis Index
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Measured: at baseline (day 0)
Western Ontario and McMaster Universities Arthritis Index
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Measured: 6 months
Western Ontario and McMaster Universities Arthritis Index
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Measured: 12 months
Western Ontario and McMaster Universities Arthritis Index
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Measured: 24 months
Knee injury and Osteoarthritis Outcome Score
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Measured: at baseline (day 0)
Knee injury and Osteoarthritis Outcome Score
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Measured: 6 months
Knee injury and Osteoarthritis Outcome Score
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Measured: 12 months
Knee injury and Osteoarthritis Outcome Score
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Measured: 24 months
36-Item Short Form Health Survey
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
Measured: at baseline (day 0)
36-Item Short Form Health Survey
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
Measured: 6 months
36-Item Short Form Health Survey
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
Measured: 12 months
36-Item Short Form Health Survey
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
Measured: 24 months
Forgotten joint score
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Measured: at baseline (day 0)
Forgotten joint score
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Measured: 6 months
Forgotten joint score
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Measured: 12 months
Forgotten joint score
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Measured: 24 months
Secondary outcomes (1)
Radiographic evaluation of prosthetic femoral component positioning
measurement of prosthetic femoral component alignment according to femoral mechanical axis
Measured: 5 days after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start13 Jan 2023
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis DurabilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 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
- NCT06321042
- Sponsor's protocol ID
- SYMPHO-EM
- Acronym
- SYMPHO-EM
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Outcomes of the Total Knee Prosthesis With Posterior Stabilization Implanted With the Use of Inertial Sensors
- ClinicalTrials.gov ID
- NCT06321042
- Acronym / sponsor ID
- SYMPHO-EM / SYMPHO-EM
- Conditions
- Prosthesis Durability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Mar 2024 (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.
evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device | – | Device: Knee arthroplasty |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients candidates to TKA surgery
Key inclusion criteria (6 listed)
- Male and female subjects 50 years of age or older and less than 85 years of age (>50 and <85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes:
- Patients consent and able to complete scheduled study procedures and follow-up assessments.
- Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.
Key exclusion criteria (3 listed)
- Simultaneous participation in other studies
- Patients not capable of understanding and wanting and therefore unable to sign the informed consent
- Patients who have already undergone hip or ankle arthroplasty, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases.
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 |
|---|---|---|
| Knee arthroplastyKnee arthroplasty surgery with perseus orthokey alignment device | Device | Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device |
Primary outcome
Knee Society Score
Time frame: at baseline (day 0)
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Knee Society Score
Time frame: 6 months
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Knee Society Score
Time frame: 12 months
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Knee Society Score
Time frame: 24 months
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Western Ontario and McMaster Universities Arthritis Index
Time frame: at baseline (day 0)
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Western Ontario and McMaster Universities Arthritis Index
Time frame: 6 months
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Western Ontario and McMaster Universities Arthritis Index
Time frame: 12 months
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Western Ontario and McMaster Universities Arthritis Index
Time frame: 24 months
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Knee injury and Osteoarthritis Outcome Score
Time frame: at baseline (day 0)
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Knee injury and Osteoarthritis Outcome Score
Time frame: 6 months
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Knee injury and Osteoarthritis Outcome Score
Time frame: 12 months
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Knee injury and Osteoarthritis Outcome Score
Time frame: 24 months
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
36-Item Short Form Health Survey
Time frame: at baseline (day 0)
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
36-Item Short Form Health Survey
Time frame: 6 months
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
36-Item Short Form Health Survey
Time frame: 12 months
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
36-Item Short Form Health Survey
Time frame: 24 months
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
Forgotten joint score
Time frame: at baseline (day 0)
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Forgotten joint score
Time frame: 6 months
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Forgotten joint score
Time frame: 12 months
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Forgotten joint score
Time frame: 24 months
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
1 secondary outcome
Radiographic evaluation of prosthetic femoral component positioning
Time frame: 5 days after index 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 Apr 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?
An observational study of Prosthesis Durability, 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 3 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 Apr 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, Prof (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?
Knee Society Score (time frame: at baseline (day 0)). The study lists 20 primary outcomes in all. 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 Apr 2026.