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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-13

Study Completion Date

2027-03-31

Brief Summary

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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;

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Detailed Description

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Conditions

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Prosthesis Durability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device

Knee arthroplasty

Intervention Type DEVICE

Knee arthroplasty surgery with perseus orthokey alignment device

Interventions

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Knee arthroplasty

Knee arthroplasty surgery with perseus orthokey alignment device

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No