NCT03843476

Personalized Spine Study Group Registry

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Medicrea, USA Corp. · Industry
• Sex: All
• Age: 10 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

As a registry, the primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR. The secondary objective is to collect clinical and radiographic outcomes of patients with Medicrea hardware as a control cohort to the patient-specific rods.

Detailed description

The registry will follow the patient during their standard of care visits. At each visit, the patient will answer questions about themselves and also fill out patient reported outcome sheets. Spinopelvic measurements will be obtained on the x-rays taken. This registry is observational only, and there is no driving hypothesis for data collection. Some broad topics of discussion are: 1. Outcomes of patients sagittal profile through the pre-operative, plan and post-operative events 2. Effectiveness of rod in conjunction with other surgical implants by measurements of fusion assessment and sagittal alignment 3. Outcomes of patients in subgroups as defined by surgery performed, comorbidities, radiographic measurement, or other outcome variables 4. Rod curvature maintenance over the follow-up period 5. Understand the post-operative risks and complications from the pre-operative condition

Conditions

• Scoliosis; Adolescence
• Degenerative Disc Disease
• Spinal Fusion
• Kyphoscoliosis
• Pseudoarthrosis of Spine
• Spinal Stenosis
• Kyphoses, Scheuermann

Interventions

Type	Name	Description
DEVICE	Patient Specific Rod	Posterior spinal fusion rod

Timeline

• Start date: 2014-01-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2019-02-18
• Last updated: 2020-09-29

Regulatory

• FDA-regulated device study