Clinical trial Recruiting at 1 site Observational Ages 10 to 85

Registry for patients with personalized spine rods

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

Run by University of Colorado, Denver · NCT04601363 · Data updated 2026-11-12

This study is testing whether personalized spine rods can help patients who have had spinal surgery feel better and have fewer problems compared to those with standard rods.

Quick facts

Study typeObservational
Ages10 Years to 85 Years
SexAll
Enrollment1000 (estimated)
SponsorUniversity of Colorado, Denver
Academic / other
Locations1 site (Aurora, Colorado)
StatusRecruiting
StartedOctober 29, 2020
Main results expectedApril 2030
Study endsApril 2030
Registry record updatedOctober 3, 2024
Trial IDNCT04601363 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients aged 10 to 85 who are undergoing spinal surgery with either patient-specific rods or standard hardware.

Probably not a fit

Patients who are unable to provide informed consent, complete questionnaires, or are pregnant may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry collects clinical and radiographic outcomes from patients who have undergone spinal surgery using patient-specific rods, as well as a control group with standard hardware. Participants will provide information during their routine care visits, including self-reported outcomes and spinopelvic measurements from x-rays. The study aims to evaluate the effectiveness of these personalized rods in maintaining rod curvature and improving patient outcomes over time. It will also assess post-operative risks and complications based on various factors such as surgery type and comorbidities.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and personalized treatment strategies for patients with spinal conditions.

How similar studies have gone: While similar observational studies have been conducted, this specific approach focusing on patient-specific rods is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Dr. Christopher Kleck, MD
    Aurora, Colorado, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.