UNiD Rods Register

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register

Conditions
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Idiopathic Scoliosis, Spinal Curvatures, Spondylolisthesis, Degenerative Scoliosis

Intervention / Treatment
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* Device: UNiD Rods


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric patients operated with Patient-specific rods<br>Patients with patient-specific rods (UNiD Rods) <18Years old | Device: UNiD Rods<br>* Spinal osteosynthesis<br>* Other names: Patient Specific Rods;|
| Adult patients operated with Patient-specific rods<br>Patients with patient-specific rods (UNiD Rods) >18Years old | Device: UNiD Rods<br>* Spinal osteosynthesis<br>* Other names: Patient Specific Rods;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological performance compared to planning | 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) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative spinal alignment | 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) | 3, 6, 12, 24 months | 
| Diasbility | To assess patients' disability through the ODI questionnaire | 3, 6, 12, 24 months | 
| Quality of life/ SRS-22 | To assess patients' quality of life through the SRS-22 questionnaire | 3, 6, 12, 24 months | 
| Patients' satisfaction | Using a satisfaction questionnaire | 3, 6, 12, 24 months | 
| Adverse event | To quantify and describe adverse events | 3, 6, 12, 24 months | 
| Revision | To quantify and describe surgical revisions | 3, 6, 12, 24 months | 
| Pain/VAS | To assess patients' pain according to VAS : to 0 (better) to 10 (worst) | 3, 6, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sagittal alignment, Surgical planning, Patient-specific, Adult Spinal Deformity