Clinical trial NCT04601363: Personalized Spine Study Group (PSSG) Registry
Official title: Personalized Spine Study Group (PSSG) Registry of Patients With Personalized Spine Rod Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scoliosis; Adolescence
Degenerative Disc Disease
Spinal Fusion
Kyphoscoliosis
Pseudoarthrosis of Spine
Spinal Stenosis
Kyphoses, Scheuermann
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Personalized Spine Study Group
First posted: 2020-10-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population is implanted with either spine hardware or is undergoing surgery to have patient-specific rod implanted

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.

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

Primary outcomes:
measure: Patient-Specific Hardware Spino-Pelvic Measurements
timeFrame: Up to 4 years
Secondary outcomes:
measure: Non Patient-Specific Hardware Spino-Pelvic Measurements
timeFrame: 1 year
Other outcomes:
measure: PROMIS CAT Physical Function
timeFrame: Up to 4 years
measure: PROMIS CAT Pain
timeFrame: Up to 4 years
measure: PROMIS CAT Anxiety
timeFrame: Up to 4 years
measure: PROMIS CAT Depression
timeFrame: Up to 4 years
measure: PROMIS CAT Satisfaction Activity Roles
timeFrame: Up to 4 years
measure: Oswestry Disability Index questionnaire (thoracic, thorocolumbar, lumbar surgery)
timeFrame: Up to 4 years
measure: Neck Disability Index questionnaire (Neck surgery only)
timeFrame: Up to 4 years
measure: Visual analog scale questionnaire
timeFrame: Up to 4 years
measure: Modified Japanese Orthopedic Association questionnaire (neck surgery only)
timeFrame: Up to 4 years
measure: Patient Satisfaction (neck surgery only)
timeFrame: Up to 4 years
measure: Scoliosis Research Society (SRS) 22r Survey
timeFrame: Up to 4 years
Locations:
city: Aurora
country: United States
facility: Dr. Christopher Kleck, MD
state: Colorado
Study officials:
References: