UNiD Rods Register

Medicrea

Status: Terminated

Conditions: Spinal Curvatures; Idiopathic Scoliosis; Spondylolisthesis; Degenerative Scoliosis

Treatments: Device: UNiD Rods

Study type: Observational

Funder types: Industry

Identifiers

NCT02926404

1501

Details and patient eligibility

About

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

Full 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

Enrollment: 743 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

743 participants in 2 patient groups

Pediatric patients operated with Patient-specific rods

Description:

Patients with patient-specific rods (UNiD Rods) \<18Years old

Treatment:

Device: UNiD Rods

Adult patients operated with Patient-specific rods

Description:

Patients with patient-specific rods (UNiD Rods) \>18Years old

Treatment:

Device: UNiD Rods