ISRCTN82579275
Active, not recruiting
Phase 4
Occipitocervical spine stabilization using PERLA® posterior occipito-cervico-thoracic fixation. A post-market clinical follow-up study
Spineart (Switzerland)0 sites20 target enrollmentDecember 15, 2022
ConditionsAcute or chronic cranio-cervical junction instability due to, but not limited to: Trauma: Atlanto-occipital dislocation, occipital condyle fracture, atlas, and axis fracturesInflammation/autoimmune disease: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, inflammatory bowel disease-associated arthropathy, tuberculosis, osteomyelitisNeoplasm: Metastasis, chordoma, Ewing tumor, osteoblastoma, osteochondroma, hemangioma, aneurysmal bone cystCongenital: Chiari malformation with basilar invagination, Down’s syndrome, Klippel–Feil syndrome, Morquio’s syndrome, os odontoideumIatrogenic: After odontoidectomy, failed previous attempts at C1–C2 fusion, after the far lateral approach with occipital condyle resection.Musculoskeletal Diseases
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- 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
- Sponsor
- Spineart (Switzerland)
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who received the PERLA® Occipital system to treat a cranio\-cervical instability of any cause and indicated for occipito\-cervical fusion
- •2\. Non\-opposition/consent for retrospective data collection
Exclusion Criteria
- •Current exclusion criteria as of 19/02/2024:
- •Does not meet the inclusion criteria.
- •Previous exclusion criteria:
- •Less than 6 months of post\-operative follow\-up
Outcomes
Primary Outcomes
Not specified
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