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
This trial does not accept healthy volunteersQualifiers
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 population
Patients who have provided consent for the collection of their data and met the protocol eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ORIGIN® CR devices
DeviceIt is planned to include consecutive eligible subjects which will be treated with the ORIGIN® CR devices.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Evaluate safety by the proportion of required revisions
Proportion of patients requiring a revision after 1-year post-procedure. The revision rate is consistent with the state of the art - Orthopaedic Data Evaluation Panel (ODEP) benchmark system (revision rate not higher than 2.5% to 3.5% at 1 year, 4% to 6% at 5 years and 5% to 7% at 10 years).
Time frame
1 year post-procedure2
Evaluate performance
Evaluate performance by means of following questionnaires: Knee Society Score (KSS) and a Knee Society Function score, a partient-reported outcome measure. The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. The maximum points which can be reached are 100 points. * Clinical status assessed by means of the KSS Knee score at 1 year post procedure * Clinical status assessed by means of the KSS Function score at 1 year post procedure
Time frame
1 year post-procedureSecondary outcomes
1
Evaluate safety by the proportion of required revisions
Proportion of patients requiring a revision after 2 years post-procedure.
Time frame
2 years post procedure2
Performance on patient satisfaction
Patient satisfaction questionnaires at 1 year and 2 years follow-up visits.
Time frame
1- and 2-years post-procedure3
Quality of Life post-procedure measured by the Knee Society score and Knee Society function questionnaire
Quality of Life measured by means of the Knee Society score and Knee Society function score questionnaires at 1- and 2-years follow-up visit.
Time frame
1- and 2-years post-procedure4
Quality of Life post-procedure measured by the Forgotten Joint Score questionnaire
Quality of Life measured by means of the Forgotten Joint Score questionnaire at 1- and 2-years follow-up visit. 12 questions refer to how aware the patients are of their artificial hip/knee joint in everyday life Scoring: For scoring the FJS-12, all responses are summed (never, 0 points; almost never, 1 point; seldom, 2 points; sometimes, 3 points; mostly, 4 points) and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100, to change the direction of the final score in a way that high scores indicate a high degree of "forgetting" the artificial joint, that is, a low degree of awareness. If more than 4 responses are missing, the total score should not be used.
Time frame
1- and 2- years post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov