A Post-market Observational ORIGIN® CR Clinical Study

Symbios

Status: Enrolling

Conditions: Total Knee Replacement

Treatments: Device: ORIGIN® CR devices

Study type: Observational

Funder types: Industry

Identifiers

NCT05607966

CLIN-G-014

Details and patient eligibility

About

The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year 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® CR.

Full description

The study is a prospective, non-comparative, non-randomized, single-arm, observational, post market study in which 199 patients will be enrolled to evaluate the safety and performance of the ORIGIN® CR devices and associated instruments.

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

Enrollment: 199 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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