Personalized Spine Study Group Registry

Withdrawn

• Conditions: Kyphoses, Scheuermann; Scoliosis; Adolescence; Spinal Fusion; Spinal Stenosis; Pseudoarthrosis of Spine; Degenerative Disc Disease; Kyphoscoliosis
• Interventions: Device: Patient Specific Rod

• Registration Number: NCT03843476
• Lead Sponsor: Medicrea, USA Corp.

Brief 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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-18
• Status Verified: 2020-09
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patient has been/ will be operated and instrumented with PSR from Medicrea
• Patient able to complete a self- administered questionnaires
• Patient able to consent or assent

Exclusion Criteria

• Patient unable to sign an informed consent form
• Patient unable to complete a self-administered questionnaire
• Patient is pregnant or planning on becoming pregnant during the duration of their study participation
• Patient is older than 85
• Patient is younger than 10

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical with Rod	Patient Specific Rod	The patient is being treated with the patient specific rod with a surgery date planned

Primary Outcome Measures

Name	Time	Method
Data collection initiative	Up to 4 years	The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR.

Secondary Outcome Measures

Name	Time	Method
Collect clinical and radiographic outcomes of patients with Medicrea hardware	1 year	A control cohort to the patient-specific rods