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Early terminated for administrative reasons
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric patients operated with Patient-specific rods | Patients with patient-specific rods (UNiD Rods) <18Years old |
| |
| Adult patients operated with Patient-specific rods | Patients with patient-specific rods (UNiD Rods) >18Years old |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UNiD Rods | Device | Spinal osteosynthesis |
|
| 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:
| 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with spinal deformities
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Fiere, MD | Centre Orthopédique Santy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH WAPI | Tournai | Belgium | ||||
| Polyclinique |
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| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| 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 |
| Bordeaux |
| France |
| Orthopôle | Bruges | France |
| CHU Estaing | Clermont-Ferrand | France |
| Hopital Saint Philibert | Lomme | France |
| Centre Orthopédique Santy | Lyon | France |
| Les Massues | Lyon | France |
| Hopital la Timone | Marseille | France |
| Hopitaux pediatriques - CHU Lenval | Nice | France |
| Hopital Trousseau | Paris | France |
| La pitié Salepetrière Hospital | Paris | France |
| Saint Etienne Hospital | Saint-Etienne | France |
| Pr Andrzej Maciejczak | Tarnów | Poland |
| D055009 |
| Spondylosis |