A Post-market Observational ORIGIN® CR Clinical Study
ConditionTotal Knee Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorSymbios Orthopedie SA
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ORIGIN® CR devices
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov