Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors (SYMPHO-EM)

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;

Study Overview

• Status: Recruiting
• Conditions: Prosthesis Durability
• Intervention / Treatment: Device: Knee arthroplasty

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Stefano Zaffagnini, Prof; Phone Number: 0516366075; Email: stefano.zaffagnini@unibo.it

Study Locations

• Italy
  • Italia
    • Bologna, Italia, Italy
      • Recruiting
      • Stefano Zaffagnini
      • Contact: Stefano Zaffagnini, MD; Phone Number: 051 6366075; Email: stefano.zaffagnini@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients candidates to TKA surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device	Device: Knee arthroplasty; Knee arthroplasty surgery with perseus orthokey alignment device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic evaluation of prosthetic femoral component positioning	measurement of prosthetic femoral component alignment according to femoral mechanical axis	5 days after index surgery

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: SYMPHO-EM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No