Personalized Spine Study Group (PSSG) Registry
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- STATUS
- Recruiting
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- End date
- Apr 12, 2027
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- participants needed
- 1000
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- sponsor
- University of Colorado, Denver
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.
Details
| Condition | Spinal Stenosis, Kyphoscoliosis, Scheuermann's Disease, spinal fusions, Scoliosis; Adolescence, Intervertebral Disc Degeneration, Spinal Fusion, degenerative disc disease, Pseudoarthrosis of Spine |
|---|---|
| Treatment | Patient Specific Rod |
| Clinical Study Identifier | NCT04601363 |
| Sponsor | University of Colorado, Denver |
| Last Modified on | 4 October 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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