Neck stabilization using the PERLA fixation system

ABSTRACT: Background and study aims This is a post-market study to confirm the performance and safety of the PERLA Occipital-Cervical-Thoracic system in the treatment of head-neck instability due that can be due to trauma, autoimmune disease, oncologic (cancer) or congenital (present from birth) reasons. This treatment results in severe restriction of head movement after surgery. Therefore, this method should be restricted to patients with head-neck instability as a last resort. The medical devices to stabilise the head-neck junction are composed of occipital plates, rods, and a screw system such as the PERLA Occipital-Cervical-Thoracic system. Head-neck fixation is the treatment of choice in most cases of traumatic occipito-cervical dislocation. It is recommended in the most recent guidelines from the American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) Joint Guidelines Committee. Who can participate? Patients who received the PERLA Occipital plate at the participating centers What does the study involve? The site will review the medical charts of patients who received the investigated device. Those patients who are eligible for the study will be contacted to invite them to participate in the study. After reading the information letter, the patients should let their surgeon know if they agree/consent before any data collection. Clinical and x-ray data will be collected for preoperative, surgical, and postoperative clinical visits performed as the site standard of care. What are the possible benefit and risks of participating? As a retrospective study of real-world evidence data collection, there are no direct benefits or risks. Where is the study run from? Three hospitals or clinic in France, Germany and Austria When is the study starting and how long is it expected to run for? June 2022 to December 2024 Who is funding the study? Spineart (Switzerland) Who is the main contact? [e-mail]

DISEASE(S): Atlas,Occipital Condyle Fracture,Inflammatory Bowel Disease-associated Arthropathy,After The Far Lateral Approach With Occipital Condyle Resection.,Morquio’s Syndrome,Osteoblastoma,Osteomyelitis Neoplasm: Metastasis,Klippel–feil Syndrome,Axis Fractures Inflammation/autoimmune Disease: Rheumatoid Arthritis,Ankylosing Spondylitis,Ewing Tumor,Chordoma,Hemangioma,Tuberculosis,But Not Limited To: Trauma: Atlanto-occipital Dislocation,Failed Previous Attempts At C1–c2 Fusion,Osteochondroma,Aneurysmal Bone Cyst Congenital: Chiari Malformation With Basilar Invagination,Os Odontoideum Iatrogenic: After Odontoidectomy,Down’s Syndrome,Acute Or Chronic Cranio-cervical Junction Instability Due To,Psoriatic Arthritis

PROVIDER: 15386 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR