Personalized Spine Study Group (PSSG) Registry
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
1,000 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Christopher Kleck, MD; jiandong hao
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal