ORIGIN® PS Modular & Associated Instruments

Symbios

Status: Active, not recruiting

Conditions: Total Knee Replacement

Treatments: Device: ORIGIN® PS Modular devices

Study type: Observational

Funder types: Industry

Identifiers

NCT06628050

CLIN-G-013

Details and patient eligibility

About

The study objective is to evaluate safety and performance of the ORIGIN® PS (postero-stabilized) Modular devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 2-6 months, 1y and 2y post-procedure and to evaluate performance by means of a Knee Society Score (KSS) Score at 2-6 months, 1y and 2y post procedure.

The hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® PS Modular.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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