This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications.
Study Type
OBSERVATIONAL
Enrollment
130
Devices: Physica TT Tibial Plate and Physica Porous KR femoral component Data collection of population that underwent total knee arthroplasty with Physica TT Tibial Plate and Physica Porous KR femoral component
Devices: Physica TT Tibial Plate and Physica Porous KR femoral component Data collection of population that underwent total knee arthroplasty with Physica TT Tibial Plate and Physica Porous PS femoral component
Casa di Cura San Camillo Hopital
Forte dei Marmi, Lucca, Italy
RECRUITINGCasa di Cura Carmona
Messina, Italy
RECRUITINGIstituto Clinico Porta Sole
Perugia, Italy
RECRUITINGPercentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery
0-100 scale. Scores rating from 80 to 100 are considered excellent, between 70 and 79 good, between 60 and 69 fair, and less than 60 poor
Time frame: 2 years after surgery
Changes in Range of Motion over time up to 2 years after surgery
Time frame: From preoperative to 2 years after surgery
Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery.
Overall score from 0 to 48, with 48 being the best outcome
Time frame: From preoperative to 2 years after surgery
Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery.
Overall score from 0 to 100, with 100 being the best outcome
Time frame: From preoperative to 2 years after surgery
Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery.
100 mm line, with 0 mm being best outcome (no pain) and 100 mm worst outcome (very severe pain)
Time frame: From preoperative to 2 years after surgery
Radiographic implant evaluation and stability assessment from postoperative (baseline) over time up to 2 years after surgery
The treated knee is analyzed postoperatively based on anteroposterior and lateral x-rays view of the knee. The following parametner are evaluated: * Presence of radiolucent lines * Presence of osteolysis * Presence of loosening * Presence of heterotopic ossification * Presence of periprosthetic fractures
Time frame: From preoperative to 2 years after surgery
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Survival rate (Kaplan-Meier) at 2 years after surgery
Time frame: From preoperative to 2 years after surgery
Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) up to 2 years follow up
Time frame: From preoperative to 2 years after surgery