Patients requiring total knee replacement.• Patients with severe painful and/or disabled knee joint, resulting from:• Non-inflammatory degenerative knee joint disease:Osteoarthritis, necrosis, post traumatic arthritis• Inflammatory knee joint disease:Rheumatoid arthritis
Conditions
Interventions
Group 1: Patients which have been treated with the ORIGIN® PS Monobloc devices for a primary Total Knee Replacement
Sponsors
Symbios Orthopédie SA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients with severe painful and/or disabled knee joint, resulting from: - Non-inflammatory degenerative knee joint disease: Osteoarthritis, necrosis, post traumatic arthritis - Inflammatory knee joint disease: Rheumatoid arthritis • Patients which have been treated with the ORIGIN® PS Monobloc devices between DEC-2018 and AUG-2020 for a primary Total Knee Replacement. • Patients willing to sign a written Informed Consent Form during their 5 years follow-up visit. • Patients who are willing to continue the follow-up at the consecutive planned visits of 5 years, 7 years, and 10 years as per standard of care
Exclusion criteria
Exclusion criteria: • Acute or chronic, local or systemic infections • Muscular, ligamental, neurological, psychological or vascular deficiencies • Bone destruction or poor bone quality that may affect implant stability • Any concomitant condition that may affect the integration or function of the implant • Allergy or hypersensitivity to any of the materials used • For CoCrMo devices (ISO 5832/4): renal, hepatic insufficiency • Hip/Knee/Ankle angle (HKA) 195 • Severe lateral 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-extractable material (e.g., screws, plates, intramedullary nails, osteosynthesis material, etc.) that may come into conflict with one of the prosthesis components • Femoral bone loss (distal and/or posterior and/or anterior) that exceeds the thickness of the tibial component (tibial plateau + tibial insert) • Need for a femoral or tibial anchoring stem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the revision rate of this prosthesis at 10 years follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| o To evaluate the success of the procedure o To evaluate the perioperative difficulties and complications o To evaluate postoperative complications and revision rate at 3-6 months, 1-, 3-, 5-, 7-years and 10 years follow-up o To evaluate Safety of the ORIGIN PS Monobloc devices at 10 years Follow-up: evaluate the revision types (femoral and/or tibial and/or patellar component) and the reasons of revisions (all Adverse Events whether known or unknown will be documented via an AE Form. o Evaluate performance of the ORIGIN® PS Monobloc devices at 10 years follow-up: clinical examination and scoring. To evaluate/compare the clinical, functional and quality of life outcomes using the following scores: - Knee Society Score (KSS, Functional and Knee Score) - Oxford Knee Score (OKS) - Forgotten Joint score (FJS) o Evaluate the radiographic limb alignment, radiolucent lines and radiographic loosening | — |
Countries
Germany
Contacts
Public ContactCarsten O. Tibesku
KniePraxis
Outcome results
None listed