Personalized Spine Study Group (PSSG) Registry

Last updated: October 1, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spine Athroplasty

Spinal Surgery

Spondylolisthesis

Treatment

Patient Specific Rod

Clinical Study ID

NCT04601363
20-2016
  • Ages 10-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient has been/ will be operated and instrumented with patient-specific rod orspine hardware (control cohort)

  • Patient able to consent or assent

Exclusion

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 theirstudy participation

  • Patient is older than 85

  • Patient is younger than 10

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Patient Specific Rod
Phase:
Study Start date:
October 29, 2020
Estimated Completion Date:
April 30, 2030

Study 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.

Connect with a study center

  • Dr. Christopher Kleck, MD

    Aurora, Colorado 80045
    United States

    Active - Recruiting

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