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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04601363
Other study ID # 20-2016
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 29, 2020
Est. completion date April 2027

Study information

Verified date September 2023
Source University of Colorado, Denver
Contact Christopher Kleck, MD
Phone 720-848-1900
Email Christopher.Kleck@CUAnschutz.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date April 2027
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 10 Years to 85 Years
Eligibility 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

Study Design


Intervention

Device:
Patient Specific Rod
Posterior spinal fusion rod

Locations

Country Name City State
United States Dr. Christopher Kleck, MD Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver Personalized Spine Study Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other PROMIS CAT Physical Function Questionnaire regarding physical function of subject Up to 4 years
Other PROMIS CAT Pain Questionnaire regarding pain of subject Up to 4 years
Other PROMIS CAT Anxiety Questionnaire regarding anxiety of subject Up to 4 years
Other PROMIS CAT Depression Questionnaire regarding depression of subject Up to 4 years
Other PROMIS CAT Satisfaction Activity Roles Questionnaire regarding normal daily activity of subject Up to 4 years
Other Oswestry Disability Index questionnaire (thoracic, thorocolumbar, lumbar surgery) Oswestry Disability Index questionnaire regarding levels of disability of subject Up to 4 years
Other Neck Disability Index questionnaire (Neck surgery only) Neck Disability Index questionnaire regarding levels of neck disability of subject Up to 4 years
Other Visual analog scale questionnaire Visual analog scale questionnaire regarding pain levels Up to 4 years
Other Modified Japanese Orthopedic Association questionnaire (neck surgery only) Modified Japanese Orthopedic Association questionnaire regarding motor disfunction levels Up to 4 years
Other Patient Satisfaction (neck surgery only) Patient satisfaction questionnaire regarding satisfaction of neck surgery Up to 4 years
Other Scoliosis Research Society (SRS) 22r Survey Scoliosis Research Society (SRS) 22r Survey regarding pain, mental health, and function of the subject. Up to 4 years
Primary Patient-Specific Hardware Spino-Pelvic Measurements 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. Up to 4 years
Secondary Non Patient-Specific Hardware Spino-Pelvic Measurements 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. 1 year
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