Personalized Spine Study Group Registry

Study Overview
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Brief Summary
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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
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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: Outcomes of patients sagittal profile through the pre-operative, plan and post-operative events Effectiveness of rod in conjunction with other surgical implants by measurements of fusion assessment and sagittal alignment Outcomes of patients in subgroups as defined by surgery performed, comorbidities, radiographic measurement, or other outcome variables Rod curvature maintenance over the follow-up period Understand the post-operative risks and complications from the pre-operative condition

Official Title
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Personalized Spine Study Group Registry

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

Intervention / Treatment
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* Device: Patient Specific Rod


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical with Rod<br>The patient is being treated with the patient specific rod with a surgery date planned | Device: Patient Specific Rod<br>* Posterior spinal fusion rod<br>* Other names: UNiD Rod;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection initiative | The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR. | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect clinical and radiographic outcomes of patients with Medicrea hardware | A control cohort to the patient-specific rods | 1 year |