This prospective clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate over 2 years after surgery, in order to assess the performance and safety of the devices. Short-term survivorship of the implant and the incidence of early complications are evaluated.
Study Type
OBSERVATIONAL
Enrollment
142
Change in Knee Society Score from preoperative to 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: From preoperative to 2 years after surgery
Change in Oxford Knee Score
Overall score from 0 to 48, with 48 being the best outcome
Time frame: From preoperative to 2 years after surgery
Change in Range of Motion
Time frame: From preoperative to 2 years after surgery
Radiographic implant evaluation and stability assessment
The treated knee is analyzed postoperatively based on knee x-rays. The following parameters 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
Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE)
Time frame: From preoperative to 2 years after surgery
Implant survival rate
Time frame: From preoperative to 2 years after surgery
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