ORIGIN® PS Modular devices: Consecutive eligible subjects have been included which have been treated with the ORIGIN® PS Modular devices.
Study summary
The study objective is to evaluate safety and performance of the ORIGIN® PS (postero-stabilized) Modular devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 2-6 months, 1y and 2y post-procedure and to evaluate performance by means of a Knee Society Score (KSS) Score at 2-6 months, 1y and 2y 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® PS Modular.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
* Male or female over 18 years of age.
* Patient, or if applicable, his or her guardian or legal representative, willing to give informed consent.
* Clinically indicated for first intention total knee replacement.
* Geographically stable and willing to return for all follow-up visits or, at a minimum, to complete the patient self-report score.
Exclusion Criteria:
* Vulnerable subject (as defined in ISO-14155)
* 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.
* Any concomitant condition likely to affect implant integration or function,
* Allergy or hypersensitivity to any of the materials used,
* For devices in CoCr Mo (ISO 5832/4): renal and hepatic impairment,
* Hip Knee Ankle (HKA) angle \< 165° or \> 195°,
* Severe collateral ligament deficiency (requiring a more constrained prosthesis),
* Major anatomical deformities,
* Severe flexion contracture or severe recurvatum,
* Revision of a partial or total knee prosthesis,
* Non-extractible material (e.g., screw, 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
Primary outcome measure(s)
Evaluate safety by the proportion of required revisions — 2 years post-op procedure Proportion of patients requiring a revision at each follow-up visit (surgery, 2-6 months, 1- and 2 years). 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).
Evaluate performance — 2 years post-op procedure Evaluate performance by means of a Knee Society Score (KSS) and a KSS Function score.
It aims to reach a KSS Knee score of at least 85,5 / 100 points and a KSS Function score of at least 72,5 / 100 points.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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