Personalized Spine Study Group Registry

Degenerative Disc Disease Clinical Trial

Official title: Personalized Spine Study Group Registry

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Kyphoscoliosis
• Kyphoses, Scheuermann
• Kyphosis
• Pseudarthrosis
• Pseudoarthrosis of Spine
• Scheuermann Disease
• Scoliosis
• Scoliosis; Adolescence
• Spinal Fusion
• Spinal Osteochondrosis
• Spinal Stenosis

• NCT number: NCT03843476
• Study type: Observational [Patient Registry]
• Source: Medicrea, USA Corp.
• Status: Withdrawn
• Start date: January 2014
• Completion date: September 2020