Personalized Spine Study Group (PSSG) Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-29

Study Completion Date

2030-04-30

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with Personalized SpineRods

The patient is being treated with the patient-specific rod with a surgery date planned

Patient Specific Rod

Intervention Type DEVICE

Posterior spinal fusion rod

Patient with other hardware

Patients with other hardware not patient-specific

No interventions assigned to this group

Interventions

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Patient Specific Rod

Posterior spinal fusion rod

Intervention Type DEVICE

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

Minimum Eligible Age

10 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No