Personalized Spine Study Group (PSSG) Registry

Recruiting

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

• Registration Number: NCT04601363
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-23
• Study Start: 2020-10-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Personalized SpineRods	Patient Specific Rod	The patient is being treated with the patient-specific rod with a surgery date planned

Primary Outcome Measures

Name	Time	Method
Patient-Specific Hardware Spino-Pelvic Measurements	Up to 4 years	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.

Secondary Outcome Measures

Name	Time	Method
Non Patient-Specific Hardware Spino-Pelvic Measurements	1 year	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.

Trial Locations

Locations (1)

Dr. Christopher Kleck, MD; 🇺🇸 Aurora, Colorado, United States