Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors

Prosthesis Durability Clinical Trial

— SYMPHO-EM  

Official title:

Evaluation of the Clinical Outcomes of the Total Knee Prosthesis With Posterior Stabilization Implanted With the Use of Inertial Sensors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321042
• Other study ID #: SYMPHO-EM
• Status: Recruiting
• Start date: January 13, 2023
• Est. completion date: March 2027

Study information

• Verified date: March 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Stefano Zaffagnini, Prof
• Phone: 0516366075
• Email: stefano.zaffagnini[@]unibo.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2027
• Est. primary completion date: January 2027
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 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°) -

2. Patients consent and able to complete scheduled study procedures and follow-up assessments.

3. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Prosthesis Durability
• Prosthesis Failure

Intervention

Device:
• Knee arthroplasty
Knee arthroplasty surgery with perseus orthokey alignment device

Locations

Country	Name	City	State
Italy	Stefano Zaffagnini	Bologna	Italia

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	Forgotten joint score	a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint	6 months
Primary	Forgotten joint score	a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint	12 months
Primary	Forgotten joint score	a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint	24 months
Secondary	Radiographic evaluation of prosthetic femoral component positioning	measurement of prosthetic femoral component alignment according to femoral mechanical axis	5 days after index surgery