Personalized Spine Study Group (PSSG) Registry

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	10 Years - 85 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04601363
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Scoliosis; Adolescence, Degenerative Disc Disease, Spinal Fusion, Kyphoscoliosis, Pseudoarthrosis of Spine, Spinal Stenosis, Kyphoses, Scheuermann

Additional Details

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.

Arms & Interventions

Arms

: Patients with Personalized SpineRods

The patient is being treated with the patient-specific rod with a surgery date planned

: Patient with other hardware

Patients with other hardware not patient-specific

Interventions

Device: - Patient Specific Rod

Posterior spinal fusion rod

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dr. Christopher Kleck, MD, Aurora, Colorado

Status

Recruiting

Address

Dr. Christopher Kleck, MD

Aurora, Colorado, 80045

Site Contact

jiandong hao

[email protected]

303-724-7457

Clinical Trial Finder