Clinical Trials in Italy / NCT06321042
Recruiting
Observational
Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors
NCT06321042 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Prosthesis Durability
Investigational drug(s) / intervention(s)
Knee arthroplasty
Knee arthroplasty: Knee arthroplasty surgery with perseus orthokey alignment device
Study 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
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 outcome measure(s)
- Knee Society Score — 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 - Knee Society Score — 6 months
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100 - Knee Society Score — 12 months
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100 - Knee Society Score — 24 months
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100 - Western Ontario and McMaster Universities Arthritis Index — 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 - Western Ontario and McMaster Universities Arthritis Index — 6 months
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96 - Western Ontario and McMaster Universities Arthritis Index — 12 months
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96 - Western Ontario and McMaster Universities Arthritis Index — 24 months
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96 - Knee injury and Osteoarthritis Outcome Score — 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 - Knee injury and Osteoarthritis Outcome Score — 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 - Knee injury and Osteoarthritis Outcome Score — 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 - Knee injury and Osteoarthritis Outcome Score — 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 - 36-Item Short Form Health Survey — 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. - 36-Item Short Form Health Survey — 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. - 36-Item Short Form Health Survey — 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. - 36-Item Short Form Health Survey — 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. - Forgotten joint score — at baseline (day 0)
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint - Forgotten joint score — 6 months
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint - Forgotten joint score — 12 months
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint - Forgotten joint score — 24 months
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Stefano Zaffagnini | Bologna | Italia | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06321042 on ClinicalTrials.gov ↗ ← All trials in Italy