NCT02926404

UNiD Rods Register

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 743 (actual)
• Sponsor: Medicrea International · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Idiopathic Scoliosis
• Spinal Curvatures
• Spondylolisthesis
• Degenerative Scoliosis

Interventions

Type	Name	Description
DEVICE	UNiD Rods	Spinal osteosynthesis

Timeline

• Start date: 2015-01-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2016-10-06
• Last updated: 2023-12-07

Locations

13 sites across 3 countries: Belgium, France, Poland