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 type | Observational |
|---|---|
| Ages | 10 Years to 85 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | October 29, 2020 |
| Main results expected | April 2030 |
| Study ends | April 2030 |
| Registry record updated | October 3, 2024 |
| Trial ID | NCT04601363 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
- Study coordinator: Christopher Kleck, MD
- Email: Christopher.Kleck@CUAnschutz.edu
- Phone: 720-848-1900
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using melatonin to improve recovery in teens after surgery
This study is testing if melatonin can help teenagers recover better and sleep well after having major surgery.
-
Blood Transfusion Factors and Cell Saver Use in Kids’ Spine Surgery
This study looks at which factors put pediatric scoliosis patients at risk for needing donor blood during posterior spinal fusion and how using a Cell Saver during surgery might reduce that need.
-
New treatment for neuropathic pain in spinal cord injury patients
This study is testing a new oral medication called EC5026 to see if it can safely help people with spinal cord injuries manage their nerve pain.
-
Yoga for back pain in adolescents with scoliosis
This study tests whether adding a structured yoga program to regular care can help teenagers with scoliosis and back pain feel better and improve their quality of life.
-
Modulating pulse-width during spinal surgery
This study is testing how different settings of electrical stimulation during spinal surgery can affect the safety and effectiveness of the procedure for patients.
-
Registry for patients using OssDsign® bone grafts in spine fusion
This study is tracking how well OssDsign® bone grafts work for people having spine fusion surgery to see if they help with recovery over two years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.