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.
The study is a prospective, non-comparative, non-randomized, single-arm, observational, post market study in which 199 patients will be enrolled to evaluate the safety and performance of the ORIGIN® CR devices and associated instruments. Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months.
Study Type
OBSERVATIONAL
Enrollment
199
It is planned to include consecutive eligible subjects which will be treated with the ORIGIN® CR devices.
GZA Ziekenhuizen - campus Sint-Augustinus
Antwerp, Belgium
RECRUITINGAZ Voorkempen
Malle, Belgium
RECRUITINGEvaluate 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-procedure
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-procedure
Evaluate safety by the proportion of required revisions
Proportion of patients requiring a revision after 2 years post-procedure.
Time frame: 2 years post procedure
Performance on patient satisfaction
Patient satisfaction questionnaires at 1 year and 2 years follow-up visits.
Time frame: 1- and 2-years post-procedure
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-procedure
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-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.