Personalized Spine Study Group (PSSG) Registry for Spinal Conditions

This study, called the Personalized Spine Study Group (PSSG) Registry, is collecting information on people who have had or will have surgery for conditions like scoliosis or degenerative disc disease. It's looking at how well a "Patient Specific Rod" (a special spinal fusion rod) works, compared to other standard spinal hardware. Researchers will measure changes in your spine and pelvis over up to four years. You might be able to join if you are between 10 and 85 years old, have had or will have spinal surgery with either a patient-specific rod or other spinal hardware, and can complete questionnaires. The current status of recruitment is unclear.

Study design
This is an observational study aiming to enroll 1000 participants. It collects data from patients who have received specific spinal implants.
What's involved
You would answer questions and fill out questionnaires during your regular doctor visits. Measurements would be taken from your standard X-rays.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 4 years to measure spino-pelvic changes.

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NCT04601363

Personalized Spine Study Group (PSSG) Registry

Recruiting
Not specifiedAges 10–85Observational
University of Colorado, Denver
~1,000 participants
Updated 2024-10-03 on ClinicalTrials.gov
What's tested:Patient Specific Rod

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient-Specific Hardware Spino-Pelvic Measurements
Measured over Up to 4 years
Scoliosis; Adolescence
Degenerative Disc Disease
Spinal Fusion
Kyphoscoliosis
Pseudoarthrosis of Spine
Spinal Stenosis
Kyphoses, Scheuermann
1 sites across 1 states
Colorado1

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Patient-Specific Hardware Spino-Pelvic MeasurementsUp 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.