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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-85
SponsorIstituto Ortopedico Rizzoli

About this trial

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;

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients candidates to TKA surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Knee arthroplasty

    Device

    Knee arthroplasty surgery with perseus orthokey alignment device

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device1 intervention

Trial outcomes

Primary outcomes

1

Knee Society Score

Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

Time frame
at baseline (day 0)
2

Knee Society Score

Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

Time frame
6 months
3

Knee Society Score

Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

Time frame
12 months
4

Knee Society Score

Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

Time frame
24 months

Secondary outcomes

1

Radiographic evaluation of prosthetic femoral component positioning

measurement of prosthetic femoral component alignment according to femoral mechanical axis

Time frame
5 days after index surgery

Other outcomes

Sponsors and contacts

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