A Post-market Observational ORIGIN® CR Clinical Study

Launched by SYMBIOS ORTHOPEDIE SA · Nov 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a specific type of knee replacement device called the ORIGIN® CR (cruciate retaining) prosthesis. Researchers want to see how well this device works for patients who need a total knee replacement, focusing on how many patients might need another surgery (called a revision) within a year after the procedure. They will also look at how much patients improve in terms of knee function and overall satisfaction with the device after one and two years.

To be eligible for this trial, participants must be over 18 years old, willing to provide consent, and have a medical need for a total knee replacement. They should not have certain health conditions that could complicate the surgery or recovery, such as serious infections or bone problems. If you join the study, you will need to return for follow-up visits at one and two years after your surgery to help researchers gather important information about your recovery and the performance of the knee replacement device.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female over 18 years of age
• • Each patient who is willing to give informed consent.
• • Clinically indicated for a total knee replacement
• • Females who are not pregnant and not planning to become pregnant ≤ 12 months. A pregnancy test should be performed for women of childbearing age
• • Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years.
• Exclusion Criteria:
• • 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 (requiring a femoral and/or a tibial stem and/or a thick insert)
• • Any concomitant condition likely to affect implant integration or function
• • Allergy or hypersensitivity to any of the materials used
• • For devices in CoCrMo (ISO 5832/4): renal and hepatic impairment
• • Hip Knee Ankle (HKA) angle \< 165° or \> 195°
• • Severe collateral ligaments deficiency (requiring a more constrained prosthesis)
• • Posterior cruciate ligament deficiency
• • Major anatomical deformities
• • Severe flexion contracture or severe recurvatum
• • Revision of a partial or total knee prosthesis
• • Non-extractible material (e.g. screws, 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