RecruitingNCT04601363

Personalized Spine Study Group (PSSG) Registry

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


Sponsor

University of Colorado, Denver

Enrollment

1,000 participants

Start Date

Oct 29, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 10 YearsMax Age: 85 Years

Inclusion Criteria2

  • Patient has been/ will be operated and instrumented with patient-specific rod or spine hardware (control cohort)
  • Patient able to consent or assent

Exclusion Criteria5

  • 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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Interventions

DEVICEPatient Specific Rod

Posterior spinal fusion rod


Locations(1)

Dr. Christopher Kleck, MD

Aurora, Colorado, United States

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NCT04601363


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