Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors
SYMPHO-EM
1 other identifier
observational
40
1 country
1
Brief 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;
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2023
CompletedFirst Submitted
Initial submission to the registry
January 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 23, 2026
April 1, 2026
4 years
January 13, 2024
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (20)
Knee Society Score
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
24 months
Forgotten joint score
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
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
6 months
Forgotten joint score
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
12 months
Forgotten joint score
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
24 months
Secondary Outcomes (1)
Radiographic evaluation of prosthetic femoral component positioning
5 days after index surgery
Study Arms (1)
Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device
Interventions
Knee arthroplasty surgery with perseus orthokey alignment device
Eligibility Criteria
Patients candidates to TKA surgery
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stefano Zaffagnini
Bologna, Italia, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor Medicine and Surgery, University of Bologna
Study Record Dates
First Submitted
January 13, 2024
First Posted
March 20, 2024
Study Start
January 13, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04