Post-Market Clinical Follow-up Observational Study of the ORIGIN® Total Knee Prosthesis and ORIGIN® Single-Use Instruments
- Conditions
- 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
- Registration Number
- DRKS00029551
- Lead Sponsor
- Symbios Orthopédie SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 172
• 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 devices between DEC-2018 and AUG-2020 for a primary Total Knee Replacement.
• Patients willing to sign a written Informed Consent Form during their 3 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
• Acute or chronic, local or systemic infections
• Muscular, ligamentary, 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) < 165° or > 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the revision rate of this prosthesis at 10 years follow-up.
- Secondary Outcome Measures
Name Time Method o To evaluate the success of the procedure<br>o To evaluate the perioperative difficulties and complications <br>o To evaluate postoperative complications and revision rate at 3-6 months, 1-, 3-, 5-, 7-years and 10 years follow-up <br>o To evaluate Safety of the ORIGIN PS 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.<br>o Evaluate performance of the ORIGIN® PS 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:<br>- Knee Society Score (KSS, Functional and Knee Score) <br>- Oxford Knee Score (OKS)<br>- Forgotten Joint score (FJS)<br>o Evaluate the radiographic limb alignment, radiolucent lines and radiographic loosening