Registry for patients with personalized spine rods
Personalized Spine Study Group (PSSG) Registry of Patients With Personalized Spine Rod Implantation
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 10 Years to 85 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04601363 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients aged 10 to 85 who are undergoing spinal surgery with either patient-specific rods or standard hardware.
Not a fit: Patients who are unable to provide informed consent, complete questionnaires, or are pregnant may not benefit from this study.
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 performed: While similar observational studies have been conducted, this specific approach focusing on patient-specific rods is relatively novel.
Eligibility criteria
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 this trial is running
Aurora, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.