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Type & Design:
Post-market, international, multicentre Prospective, parallel groups, open-label, baseline controlled
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Inclusion criteria
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:
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
164 participants in 2 patient groups
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Central trial contact
Federica Azzimonti
Data sourced from clinicaltrials.gov
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