Cervicothoracic spine stabilization
Conditions
Interventions
Group 1: The study is a post-market clinical follow-up (PMCF), observational study with a CE marked medical device (PERLA® posterior cervicothoracic fixation system) to evaluate technical success of t
Sponsors
SPINEART SA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: =18 2. Patients presenting the following acute and chronic instabilities of the cervical spine (C1 to C7) and thethoracic spine from T1-T3, following pathologiesconfirmed clinically and radiographic assessment: ? traumatic spinal fractures and/or traumatic dislocations ? instability or deformity ? failed previous fusions (e.g., pseudarthrosis) ? tumours involving the cervical spine ? degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or armpain of discogenic origin as confirmed by radiographic studies, and degenerative disease of thefacets with instability 3. Psychosocially, mentally and physically able to fullycomply with the protocol including adhering to followup schedule and filling out forms. 4. Written voluntary informed consent for use of their clinical, radiological and surgical data for scientific purposes related to safety and efficacy of the implanted device.
Exclusion criteria
Exclusion criteria: 1. Overt infection or distant foci of infections 2. Local inflammation, with or without fever or leucocytosis 3. Pregnancy 4. Morbid obesity (BMI >40) 5. Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis 6. Suspected or documented metal allergy or intolerance 7. Anatomical abnormalities with potential risk on intraoperative neurological and/or vascular injury 8. Severe comminuted fractures (such that segments may not be maintained in satisfactory proximate reduction) 9. Displaced, non-reduced fractures with bone loss 10. The presence of marked bone absorption or severe metabolic bone disease that could compromise the fixation achieved 11. Poor prognosis for good wound healing (e.g., decubitus ulcer, uncontrolled diabetes, severe protein deficiency, and/or malnutrition) 12. No need of bone graft or fusion 13. Condition not described in the "Instructions for use"
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compound endpoint of spinal stability assessed on X-rays at 12 months defined as a maximum change of Cobb angle over instrumented levels of +/-5 degrees and no device-related complications. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The potential risk when using PERLA® posterior cervicothoracic fixation system, will be assessed intra and post-operatively, during all 12 months postoperative follow-up, by the rate of the complications: ? Directly or indirectly related to the device: Screw breakage, Instrumentation pull-out, Rod migration ? Related to the procedure: Per-operative vertebral breach, Nerve root irritation / injury / numbness, Dural injury, Vertebral artery injury, Venous plexus injury. The overall rate of revision surgeries will be reported. 2. Clinical and neurological parameters, evaluated at 6 weeks, 12 months postoperatively: CIP-PERLA®-PMCF ? Neurological status, reported as rate of: Improvement, Stable or Degradation (ASIA Impairment Scale) ? Neck and Radicular pain (VAS Arm and VAS Neck score); ? Functional disability index (NDI score); ? Quality of Life Index and Patient Satisfaction (EQ-5D score); ? Modified Japanese Orthopedic Association (mJOA) score 3. Fusion status, at treated level, qualitatively valuated by CT at 12 months postoperatively as follows: ? Solid fusion, Fibrous union, Non-union. | — |
Countries
Germany
Contacts
Public ContactHouria;Salvinia Belalit;Mletzko
SPINEART SA;RQM+ (Germany) GmbH
Outcome results
None listed