Personalized Spine Study Group (PSSG) Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient Specific Rod.
- Who it may be relevant to
- Registry conditions: Scoliosis; Adolescence, Degenerative Disc Disease, Spinal Fusion, Kyphoscoliosis. Basic parameters: 10 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Personalized Spine Study Group (PSSG) Registry of Patients With Personalized Spine Rod Implantation
Overview
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
- Device Patient Specific Rod
Posterior spinal fusion rod
Primary outcome measures
- Patient-Specific Hardware Spino-Pelvic Measurements [Time frame: Up to 4 years]
Secondary outcome measures (1)
- Non Patient-Specific Hardware Spino-Pelvic Measurements [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Dr. Christopher Kleck, MD — Aurora
Identifiers
NCT: NCT04601363 · 20-2016