Physica CR and Physica PS Clinical Trial

The Timed-get-up-and-go test (TUG) is a simple test widely used to assess a person's mobility, requiring both static and dynamic balance. Subjects are instructed to walk as quickly as they feel safe and comfortable. Time (seconds) is taken to rise from a chair (seat height, 46 cm), walk 3 meters, turn around, walk back to the chair, then sit down wearing regular footwear. The TUG has excellent inter-rater and intra-rater reliability. Timing starts on the signal to start and terminates once the participant sits back down fully with their back resting on the back of the chair. Regular walking aid is allowed and recorded if required. Two trials are performed and the faster of the 2 trials is recorded to nearest 10th of a second.

KOOS was developed and is validated for several cohorts of younger and/or more active patients with knee injury and/or knee osteoarthritis. KOOS is a 42-item self-administered self-explanatory questionnaire that covers five patient-relevant dimensions: Pain, Other Disease-Specific Symptoms, Active Daily Living Function, Sport and Recreation Function, and knee-related Quality of Life. The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures.

A Satisfaction Visual Analogue Scale (VAS) system was developed to evaluate patient satisfaction with the TKR at follow-up, similar to the system used to measure pain. The scale consists of a 10-cm-long horizontal line ranging from completely satisfied to totally unsatisfied. On top of the scale the question: "Are you satisfied with your knee prosthesis?" is placed. Facial expressions are put above the line to express satisfaction visually. The patient receives this scale and is asked to mark the line at a point that would match his/her satisfaction. With a ruler, the number of millimetres is measured and converted to points. The satisfaction VAS system ranges from 100 (best, completely satisfied) to 0 (worst, totally unsatisfied) points.

The Forgotten Joint Scores (FJS-12) comprises measures for the assessment of joint-specific patient-reported outcome and focus on patients' awareness of a specific joint in everyday life. FJS-12 is a 12-item questionnaire that integrates variables such as pain, stiffness, function on activities of daily living, patients' expectations and activity levels and finally psychosocial factors. It consists of 12 questions and is scored using a 5-point Likert response format (never-almost never-seldom-sometimes-mostly) with the raw scores transformed onto a 0-100 point scale. High scores indicate good outcome, that is, a high degree of "forgetting" the joint. FJS-12 evaluation isn't performed preoperatively.

The radiographical assessment includes a modified evaluation of presence, location and thickness of periprosthetic radiolucent lines. The sums of the width of radiolucent lines for every component are categorised as follows: 4 or less and non progressive is probably not significant; 5-9 should be closely followed for progression; 10 or greater signifies possible or impending failure regardless of symptoms. Signs of a radiographically loose prosthesis include progressively enlarging luciencies, subsidence of the component or a change in alignment from previous films.

Survival rate of the implant (Kaplan-Meier)

Incidence of device-related adverse events( AE), serious adverse events (SAE), device deficiency (DD), adverse device effect (ADE), serious adverse device effect (SADE).