eck stabilization using the PERLA® Occipital fixation system

Phase 4

• 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’s syndrome, Klippel–Feil syndrome, Morquio’s syndrome, os odontoideum; Iatrogenic: After odontoidectomy, failed previous attempts at C1–C2 fusion, after the far lateral approach with occipital condyle resection.; Musculoskeletal Diseases

• Registration Number: ISRCTN82579275
• Lead Sponsor: Spineart (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-15
• Last Update Posted: 4 March 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Observational
• Study Design: Not specified