Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Knee arthroplasty.
- Who it may be relevant to
- Registry conditions: Prosthesis Durability. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Clinical Outcomes of the Total Knee Prosthesis With Posterior Stabilization Implanted With the Use of Inertial Sensors
Overview
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;
Interventions
- Device Knee arthroplasty
Knee arthroplasty surgery with perseus orthokey alignment device
Primary outcome measures
- Knee Society Score [Time frame: at baseline (day 0)]
- Knee Society Score [Time frame: 6 months]
- Knee Society Score [Time frame: 12 months]
- Knee Society Score [Time frame: 24 months]
- Western Ontario and McMaster Universities Arthritis Index [Time frame: at baseline (day 0)]
- Western Ontario and McMaster Universities Arthritis Index [Time frame: 6 months]
- Western Ontario and McMaster Universities Arthritis Index [Time frame: 12 months]
- Western Ontario and McMaster Universities Arthritis Index [Time frame: 24 months]
- Knee injury and Osteoarthritis Outcome Score [Time frame: at baseline (day 0)]
- Knee injury and Osteoarthritis Outcome Score [Time frame: 6 months]
Secondary outcome measures (1)
- Radiographic evaluation of prosthetic femoral component positioning [Time frame: 5 days after index surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Stefano Zaffagnini — Bologna
Identifiers
NCT: NCT06321042 · SYMPHO-EM