Dr. Christopher Kleck, MD
Aurora, Colorado, 80045, United States
Location status: Recruiting
NCT Number: NCT04601363
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.
Interested in participating?
Request Info10 year–85 year
All sexes
Observational
Aurora, Colorado, 80045, United States
Location status: Recruiting
The registry follows patient during their standard of care visits. During a standard of care visit, a study subject will be required to answer questions about themselves and fill out patient reported outcome questionnaires. Spinopelvic measurements will be collect from standard of care x-rays. This registry is observational only used to address patient outcomes sagittal profile through the pre-operative, plan and post-operative events. Rod effectiveness in conjunction with other surgical implants by fusion assessment and sagittal alignment measurements. Patient outcomes in subgroups defined by surgery performed, comorbidities, radiographic measurement, or other outcome variables. Rod curvature maintenance during the follow-up period. Better understanding of the post-operative risks and complications from the pre-operative condition.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Posterior spinal fusion rod
Time frame: Up 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.
Time frame: 1 year
The study will collect clinical and radiographic outcomes of patients implanted 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.
Time frame: Up to 4 years
Questionnaire regarding physical function of subject
Time frame: Up to 4 years
Questionnaire regarding pain of subject
Time frame: Up to 4 years
Questionnaire regarding anxiety of subject
Time frame: Up to 4 years
Questionnaire regarding depression of subject
Time frame: Up to 4 years
Questionnaire regarding normal daily activity of subject
Time frame: Up to 4 years
Oswestry Disability Index questionnaire regarding levels of disability of subject
Time frame: Up to 4 years
Neck Disability Index questionnaire regarding levels of neck disability of subject
Time frame: Up to 4 years
Visual analog scale questionnaire regarding pain levels
Time frame: Up to 4 years
Modified Japanese Orthopedic Association questionnaire regarding motor disfunction levels
Time frame: Up to 4 years
Patient satisfaction questionnaire regarding satisfaction of neck surgery
Time frame: Up to 4 years
Scoliosis Research Society (SRS) 22r Survey regarding pain, mental health, and function of the subject.
Contact information is provided by the study sponsor or research team.
Christopher Kleck, MD
CONTACT
jiandong hao
CONTACT
University of Colorado, Denver
Other
Personalized Spine Study Group (PSSG) Registry of Patients With Personalized Spine Rod Implantation
Acronym: PSSG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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