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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06321042
Other study ID # SYMPHO-EM
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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