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

Plain Language Summary

Simplified for easier understanding

This registry study is following people who have spine surgery using custom-made, patient-specific hardware — rods and implants that are shaped specifically for each person's anatomy rather than using off-the-shelf devices. By tracking outcomes over time for both patients who receive custom hardware and those who receive standard hardware, researchers hope to learn which approach leads to better results, faster recovery, and fewer complications. This is an observational study, meaning there is no experimental treatment. Participants simply agree to share their medical records and answer health questionnaires about their spine surgery experience. The goal is to build a long-term database that can help doctors make better decisions for future patients. You may be eligible if: - You have had or are scheduled to have spine surgery with instrumentation (patient-specific or standard hardware) - You are between 10 and 85 years old - You are able to provide informed consent (or parental consent if under 18) - You are able to complete self-administered questionnaires You may NOT be eligible if: - You are unable to sign an informed consent form - You cannot complete a self-administered questionnaire - You are pregnant or planning to become pregnant during the study - You are older than 85 or younger than 10 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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