Degenerative Disc Disease, Kyphoscoliosis, Kyphoses, Scheuermann, Pseudoarthrosis of Spine, Scoliosis; Adolescence, Spinal Fusion, Spinal Stenosis
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEPatient Specific Rod
Posterior spinal fusion rod
Sponsors
Personalized Spine Study Group
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
10 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Specific Hardware Spino-Pelvic Measurements | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non Patient-Specific Hardware Spino-Pelvic Measurements | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| PROMIS CAT Anxiety | Up to 4 years | Questionnaire regarding anxiety of subject |
| PROMIS CAT Depression | Up to 4 years | Questionnaire regarding depression of subject |
| PROMIS CAT Satisfaction Activity Roles | Up to 4 years | Questionnaire regarding normal daily activity of subject |
| Oswestry Disability Index questionnaire (thoracic, thorocolumbar, lumbar surgery) | Up to 4 years | Oswestry Disability Index questionnaire regarding levels of disability of subject |
| PROMIS CAT Physical Function | Up to 4 years | Questionnaire regarding physical function of subject |
| Visual analog scale questionnaire | Up to 4 years | Visual analog scale questionnaire regarding pain levels |
| Modified Japanese Orthopedic Association questionnaire (neck surgery only) | Up to 4 years | Modified Japanese Orthopedic Association questionnaire regarding motor disfunction levels |
| Patient Satisfaction (neck surgery only) | Up to 4 years | Patient satisfaction questionnaire regarding satisfaction of neck surgery |
| Scoliosis Research Society (SRS) 22r Survey | Up to 4 years | Scoliosis Research Society (SRS) 22r Survey regarding pain, mental health, and function of the subject. |
| Neck Disability Index questionnaire (Neck surgery only) | Up to 4 years | Neck Disability Index questionnaire regarding levels of neck disability of subject |
| PROMIS CAT Pain | Up to 4 years | Questionnaire regarding pain of subject |
Countries
United States
Contacts
Primary ContactChristopher Kleck, MD
Backup Contactjiandong hao
Outcome results
None listed