Trial Details
Not RecruitingBasic 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 |