Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06321042

Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis 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;

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prosthesis Durability Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stefano Zaffagnini

Bologna, Italia, Italy

Location status: Recruiting

Location contact

Stefano Zaffagnini, MD

CONTACT

[email protected]

051 6366075

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Knee arthroplasty

Device

Knee arthroplasty surgery with perseus orthokey alignment device

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. 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

  20. 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

Secondary outcomes

  1. Radiographic evaluation of prosthetic femoral component positioning

    Time frame: 5 days after index surgery

    measurement of prosthetic femoral component alignment according to femoral mechanical axis

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Zaffagnini, Prof

CONTACT

[email protected]

0516366075

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: SYMPHO-EM

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.