Degenerative Scoliosis, Idiopathic Scoliosis, Spinal Curvatures, Spondylolisthesis
Conditions
Keywords
Sagittal alignment, Surgical planning, Patient-specific, Adult Spinal Deformity
Brief summary
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD). This study aims to assess performance, clinical outcomes and safety
Detailed description
Despite decades of treatment and great diversity of instrumentation, the objective of sagittal spinal realignment in adult spinal deformity is achieved in only 38% of patients which reflects an inadequacy of the approach currently used. Patient specific rods were created by Medicrea to address this gap and support surgeons in achieving what they planned to perform in terms of spinal correction based on preoperative X-rays analyses. Beside to help surgeons in planning and to improve performance, the avoidance of manual bending is supposed to save time during surgery and to limit notches which should then reduce rod fractures responsible for surgical revisions. A European register-like study has been set-up to assess radiological performance, clinical outcomes and revision rate following implantation of patient-specific rods in adult spinal deformities
Interventions
DEVICEUNiD Rods
Spinal osteosynthesis
Sponsors
Medicrea International
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient operated with UNiD® Patient Specific rods from MEDICREA® INTERNATIONAL * Patient affiliated to health care insurance (social security in France) * Patient able to complete a self-administered questionnaire * Patient able to sign a disclosure form or a non-opposition form
Exclusion criteria
* Patient not operated with Patient Specific rods from MEDICREA® INTERNATIONAL * Pregnant patient * Patient not affiliated to health care insurance (social security in France) * Patient unable to sign a disclosure form * Patient unable to complete a self-administered questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological performance compared to planning | 12 months | The primary objective is to compare the planned sagittal parameters with those obtained postoperatively including but not limited to: * Sagittal vertical axis (SVA) * Lumbar Lordosis (LL) * Thoracic Kyphosis (TK) * Pelvic Tilt (PT) * Pelvic Incidence (PI) * Sacral Slope (SS) * Cobb Angle (CA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative spinal alignment | 3, 6, 12, 24 months | Evaluation of the deformity correction in the sagittal and/or coronal plan. The primary objective is to compare the preoperative sagittal parameters with those obtained postoperatively including but not limited to: Sagittal vertical axis (SVA) Lumbar Lordosis (LL) Thoracic Kyphosis (TK) Pelvic Tilt (PT) Pelvic Incidence (PI) Sacral Slope (SS) Cobb Angle (CA) |
| Diasbility | 3, 6, 12, 24 months | To assess patients' disability through the ODI questionnaire |
| Patients' satisfaction | 3, 6, 12, 24 months | Using a satisfaction questionnaire |
| Quality of life/ SRS-22 | 3, 6, 12, 24 months | To assess patients' quality of life through the SRS-22 questionnaire |
| Revision | 3, 6, 12, 24 months | To quantify and describe surgical revisions |
| Pain/VAS | 3, 6, 12, 24 months | To assess patients' pain according to VAS : to 0 (better) to 10 (worst) |
| Adverse event | 3, 6, 12, 24 months | To quantify and describe adverse events |
Countries
Belgium, France, Poland
Outcome results
None listed