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NCT05607966
A Post-market Observational ORIGIN® CR Clinical Study
Conditions: Total Knee Replacement
Sex: All
Ages: 18 Years – 99 Years
Enrollment: 199
Sponsor: Symbios Orthopedie SA
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 Criteria
Inclusion Criteria:Male and female over 18 years of ageEach patient who is willing to give informed consent.Clinically indicated for a total knee replacementFemales who are not pregnant and not planning to become pregnant ≤ 12 months.
A pregnancy test should be performed for women of childbearing ageGeographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years.Exclusion Criteria:Life expectancy ≤ 1 yearAcute or chronic, local or systemic infectionMental illnessMuscular, ligamental, neurological, psychological or vascular deficitsBone 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 functionAllergy or hypersensitivity to any of the materials usedFor devices in CoCrMo (ISO 5832/4): renal and hepatic impairmentHip Knee Ankle (HKA) angle < 165° or > 195°Severe collateral ligaments deficiency (requiring a more constrained prosthesis)Posterior cruciate ligament deficiencyMajor anatomical deformitiesSevere flexion contracture or severe recurvatumRevision of a partial or total knee prosthesisNon-extractible material (e.g.
screws, plate, intramedullary nail, osteosynthesis material…) which can create a conflict with any component of the prosthesisDistal and/or posterior and/or anterior femoral bone loss which exceeds the femoral component thicknessProximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert)
Source: ClinicalTrials.gov (NCT05607966). StuddyBuddy aggregates publicly available trial information.