A Post-market Observational ORIGIN® CR Clinical Study
Symbios Orthopedie SA
199 participants
Jul 10, 2024
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria16
- 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
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Interventions
It is planned to include consecutive eligible subjects which will be treated with the ORIGIN® CR devices.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05607966