Physica CR and Physica PS Clinical Trial

Study Overview
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Brief Summary
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Type & Design: Post-market, international, multicentre Prospective, parallel groups, open-label, baseline controlled Objectives: Assessment of clinical, radiographic and patient-reported outcomes of Physica CR and PS designs Incidence of adverse events and identification of possible risk factors for unsatisfactory results Mid-term survivorship of the implants

Official Title
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A Multicentre, Prospective Study Evaluating Clinical, Radiographic and Patient-reported Outcomes of Total Knee Arthroplasty With Physica CR or Physica PS Prosthesis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Physica CR
* Device: Physica PS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females Age 22-78 years Any race Ambulatory patients Patients who have a medical condition with over 5 years of life expectancy Patients with painful primary or secondary knee osteoarthritis Patients who have undamaged and functional collateral and posterior cruciate ligaments for the group requiring Physica CR or Patients who have undamaged and functional collateral ligaments for the group requiring Physica PS Patients with flexion ≥90° on the affected side Patients with a fixed flexion contracture <20° Patients who understand the conditions of the study and are willing and able to comply with the prescribed rehabilitation and to perform all scheduled follow-up visits Patients who have signed the Ethics Committee approved study-specific Informed Consent Form prior to the surgery Exclusion Criteria: Previous partial knee replacement or patellofemoral joint replacement and previous patellectomy Primary Total Knee Replacement (TKR) in the affected knee Varus deformity >20° or Valgus deformity >15° Patients with a fixed flexion contracture >20° Previous intra-articular fractures of the affected knee Patients with previous methaphysal tibial or femoral osteotomy performed less than 5 years before the screening visit, in case of plate removal surgery it is done early than 1 year ago to screening. Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS< 60 points Patients with symptomatic Osteoarthritis (OA) of the spine if the assessment of pain with Numeric Rating Scale is >4 Patients with an history of infections (on the affected knee or systemic) Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance Patients who have damaged or absence of the posterior cruciate ligament for the group requiring Physica CR Patients with known or suspicious metal hypersensitivity Recurrent medical history of severe allergic or immune-mediated reactions Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation Current treatment or treatment within the previous 2 years before the screening visit for malignant and life-threatening non-malignant disorders Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including: any intercurrent chronic disease or condition that may interfere with the completion of the 5-year follow-up, such as liver disease, severe coronary disease, drug or alcohol abuse significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device known metabolic disorders leading to progressive bone deterioration Patients who have known co-existent medical condition with less 5 years of life expectancy Previous organ transplant surgery Any psychiatric illness that would prevent comprehension of the details and nature of the study Participation in any experimental drug/device study within the 6 months prior to the screening visit Female patients who are pregnant, nursing, or planning a pregnancy

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Physica CR<br>Patients who have undamaged and functional collateral and posterior cruciate ligaments for the group requiring Physica CR | Device: Physica CR<br>* Cruciate tretaining total knee replacement<br>|
| Physica PS<br>Patients who have undamaged and functional collateral ligaments for the group requiring Physica PS | Device: Physica PS<br>* Posterior Stabilized total knee replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical change in Knee Society Score (KSS) |  | from preoperative (baseline) to 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical change in Knee Society Score (KSS) |  | preoperatively (baseline), 3 months, 6 months, 1 year, 2 years, 3 years after surgery | 
| Functional change in Timed up and Go (TUG) test |  | preoperatively (baseline), 3 months, 6 months, 1 year, 2 years, 3 years and 5 years after surgery | 
| Change in Knee injury and Osteoarthritis Outcome Score (KOOS) |  | preoperatively (baseline), 3 months, 6 months, 1 year, 2 years, 3 years and 5 years after surgery | 
| Change in Satisfaction Visual Analogue Scale (Satisfaction VAS) |  | 3 months (baseline), 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery | 
| Change in Forgotten Joint Score (FJS-12) |  | 3 months (baseline), 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery | 
| Thickness and location of symptomatic radiolucent lines |  | 0 months (baseline), 3 months, 6 months, 1 year, 2 years, 3 years and 5 years after surgery | 
| Survival rate (Kaplan-Meier) |  | 3 years and 5 years after surgery | 
| Incidence of device-related AE/SAE |  | 0 months, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery |