Clinical trial NCT06321042: Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors
Official title: Evaluation of the Clinical Outcomes of the Total Knee Prosthesis With Posterior Stabilization Implanted With the Use of Inertial Sensors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prosthesis Durability
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients candidates to TKA surgery

Brief 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;


Eligibility criteria: 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.

Primary outcomes:
measure: Knee Society Score
timeFrame: at baseline (day 0)
measure: Knee Society Score
timeFrame: 6 months
measure: Knee Society Score
timeFrame: 12 months
measure: Knee Society Score
timeFrame: 24 months
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: at baseline (day 0)
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: 6 months
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: 12 months
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: 24 months
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: at baseline (day 0)
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 6 months
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 12 months
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 24 months
measure: 36-Item Short Form Health Survey
timeFrame: at baseline (day 0)
measure: 36-Item Short Form Health Survey
timeFrame: 6 months
measure: 36-Item Short Form Health Survey
timeFrame: 12 months
measure: 36-Item Short Form Health Survey
timeFrame: 24 months
measure: Forgotten joint score
timeFrame: at baseline (day 0)
measure: Forgotten joint score
timeFrame: 6 months
measure: Forgotten joint score
timeFrame: 12 months
measure: Forgotten joint score
timeFrame: 24 months
Secondary outcomes:
measure: Radiographic evaluation of prosthetic femoral component positioning
timeFrame: 5 days after index surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Stefano Zaffagnini
state: Italia
Study officials:
References: