Trial Details

Not Recruiting
Basic Information
Clinical ID c2231
Identifier ISRCTN82579275
Trial Title Occipitocervical spine stabilization using PERLA posterior occipito-cervico-thoracic fixation. A post-market clinical follow-up study
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Acute or chronic cranio-cervical junction instability due to, but not limited to: Trauma: Atlanto-occipital dislocation, occipital condyle fracture, atlas, and axis fractures; Inflammation/autoimmune disease: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, inflammatory bowel disease-associated arthropathy, tuberculosis, osteomyelitis; Neoplasm: Metastasis, chordoma, Ewing tumor, osteoblastoma, osteochondroma, hemangioma, aneurysmal bone cyst; Congenital: Chiari malformation with basilar invagination, Down syndrome, Klippel-Feil syndrome, Morquio syndrome, os odontoideum; Iatrogenic: After odontoidectomy, failed previous attempts at C1-2 fusion, after the far lateral approach with occipital condyle resection. Musculoskeletal Diseases
Interventions Any patient who has received a Perla Occipital system in the participating center will be asked for the data collection of their retrospective data.
Participant Information
Sponsor Spineart (Switzerland)
City -
Country/Region Austria;France;Germany
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Observational
Phase PHASE4
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2024-07-03