ORIGIN® PS Modular & Associated Instruments

The study is ambispective, post market, non-comparative, non-randomized, multicentric and observational in which 200 patients will be enrolled to evaluate the safety and performance of the ORIGIN® PS Modular devices and associated instruments.

Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months.

Inclusion criteria

• Male or female over 18 years of age.
• Patient, or if applicable, his or her guardian or legal representative, willing to give informed consent.
• Clinically indicated for first intention total knee replacement.
• Geographically stable and willing to return for all follow-up visits or, at a minimum, to complete the patient self-report score.

Exclusion criteria

• Vulnerable subject (as defined in ISO-14155)
• Acute or chronic, local or systemic infection,
• Muscular, ligamental, neurological, psychological or vascular deficits,
• Bone destruction or poor bone quality likely to affect implant stability.
• Any concomitant condition likely to affect implant integration or function,
• Allergy or hypersensitivity to any of the materials used,
• For devices in CoCr Mo (ISO 5832/4): renal and hepatic impairment,
• Hip Knee Ankle (HKA) angle < 165° or > 195°,
• Severe collateral ligament deficiency (requiring a more constrained prosthesis),
• Major anatomical deformities,
• Severe flexion contracture or severe recurvatum,
• Revision of a partial or total knee prosthesis,
• Non-extractible material (e.g., screw, plate, intramedullary nail, osteosynthesis material) which can create a conflict with any component of the prosthesis,
• Distal and/or posterior and/or anterior femoral bone loss which exceeds the femoral component thickness,
• Proximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert),
• Bone degradation requiring an anchoring stem for femoral component