Personalized Spine Study Group (PSSG) Registry

Study Overview
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Brief Summary
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The primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. The secondary objective is to collect clinical and radiographic outcomes of patients with hardware as a control cohort to the patient-specific rods.

Detailed Description
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The registry follows patient during their standard of care visits. During a standard of care visit, a study subject will be required to answer questions about themselves and fill out patient reported outcome questionnaires. Spinopelvic measurements will be collect from standard of care x-rays. This registry is observational only used to address patient outcomes sagittal profile through the pre-operative, plan and post-operative events. Rod effectiveness in conjunction with other surgical implants by fusion assessment and sagittal alignment measurements. Patient outcomes in subgroups defined by surgery performed, comorbidities, radiographic measurement, or other outcome variables. Rod curvature maintenance during the follow-up period. Better understanding of the post-operative risks and complications from the pre-operative condition.

Official Title
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Personalized Spine Study Group (PSSG) Registry of Patients With Personalized Spine Rod Implantation

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 patient-specific rod or spine hardware (control cohort) 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 |
| --- | --- |
| Patients with Personalized SpineRods<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>|
| Patient with other hardware<br>Patients with other hardware not patient-specific | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Specific Hardware Spino-Pelvic Measurements | The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. Measurements are collected from the inferior endplate of the vertebral body C2 to the superior endplate of vertebral body S1 on the lateral view x-ray and from the superior endplate of vertebral body T1 to the superior endplate of vertebral body S1 in the Anteroposterior view x-ray. | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non Patient-Specific Hardware Spino-Pelvic Measurements | The study will collect clinical and radiographic outcomes of patients implanted rods. Measurements are collected from the inferior endplate of the vertebral body C2 to the superior endplate of vertebral body S1 on the lateral view x-ray and from the superior endplate of vertebral body T1 to the superior endplate of vertebral body S1 in the Anteroposterior view x-ray. | 1 year |