Post-Market Clinical Follow-up Observational Study of the ORIGIN® Total Knee Prosthesis and ORIGIN® Single-Use Instruments - CLIN-G-008a

Symbios Orthopédie SA0 个研究点目标入组 172 人开始时间: 2022年10月6日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

发起方

Symbios Orthopédie SA