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A Post-market Observational ORIGIN® CR Clinical Study

Recruitingn/aAges 18 Years - 99 YearsAllSymbios Orthopedie SA
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • ORIGIN® CR devices
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Where

2 sites
GZA Ziekenhuizen - campus Sint-Augustinus
Antwerp, Belgium
AZ Voorkempen
Malle, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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