Physica KR Fluoroscopy Study

Inclusion criteria

• Patientsoperated in The Royal Bournemouth Hospital NHS Foundation Trust and who has received a Physica KR implant
• Patients achieving a ROM ≥ 100° at 6 week follow-up in the Physica KR clinical trial (K-06 Study protocol 30/10/2013 v 1.0);
• Patients affected by primary or secondary OA before surgery;
• Patients with an appropriate intial fixation and stability of the knee prosthesis;
• Patients with undamaged and functional collateral and posterior cruciate ligaments (no ligamentous imbalance or pain);
• Patients who understand the requirements of the study and are willing and able to comply with activities required for fluoroscopic examination;
• Patients who have signed the Ethics Committee approved study-specific Informed Consent Form.

Exclusion criteria

• Patients with a ROM < 100° at 6-week follow-up in Physica KR clinical trial (K-06- Study protocol 30/10/2013 v 1.0);
• Patients affected by rheumatoid arthritis;
• Patients with malalignment or axial malrotation of the knee prosthesis;
• Patients who had or have planned a surgery on their uninvolved knee within a year;
• Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance;
• Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation;
• Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device;
• 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 preoperative visit, excluding the Physica KR clinical trial (K-06 Study protocol 30/10/2013 v 1.0);
• Female patients who are pregnant, nursing, or planning a pregnancy.