UNiD Rods Register

Medicrea International743 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

743

Conditions

Idiopathic Scoliosis Spinal Curvatures Spondylolisthesis Degenerative Scoliosis

Interventions

UNiD RodsDEVICE

Spinal osteosynthesis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (13)

CH WAPI

Tournai, Belgium

Polyclinique

Bordeaux, France

Orthopôle

Bruges, France

CHU Estaing

Clermont-Ferrand, France

Outcomes

Primary Outcomes

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)

Time frame: 12 months

Secondary Outcomes

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)