Personalized Spine Study Group (PSSG) Registry

Degenerative Disc Disease Clinical Trial

— PSSG  

Official title:

Personalized Spine Study Group (PSSG) Registry of Patients With Personalized Spine Rod Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04601363
• Other study ID #: 20-2016
• Status: Recruiting
• Start date: October 29, 2020
• Est. completion date: April 2027

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: Christopher Kleck, MD
• Phone: 720-848-1900
• Email: Christopher.Kleck[@]CUAnschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2027
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Kyphoscoliosis
• Kyphoses, Scheuermann
• Kyphosis
• Pseudarthrosis
• Pseudoarthrosis of Spine
• Scheuermann Disease
• Scoliosis
• Scoliosis; Adolescence
• Spinal Fusion
• Spinal Osteochondrosis
• Spinal Stenosis

Intervention

Device:
• Patient Specific Rod
Posterior spinal fusion rod

Locations

Country	Name	City	State
United States	Dr. Christopher Kleck, MD	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Personalized Spine Study Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PROMIS CAT Physical Function	Questionnaire regarding physical function of subject	Up to 4 years
Other	PROMIS CAT Pain	Questionnaire regarding pain of subject	Up to 4 years
Other	PROMIS CAT Anxiety	Questionnaire regarding anxiety of subject	Up to 4 years
Other	PROMIS CAT Depression	Questionnaire regarding depression of subject	Up to 4 years
Other	PROMIS CAT Satisfaction Activity Roles	Questionnaire regarding normal daily activity of subject	Up to 4 years
Other	Oswestry Disability Index questionnaire (thoracic, thorocolumbar, lumbar surgery)	Oswestry Disability Index questionnaire regarding levels of disability of subject	Up to 4 years
Other	Neck Disability Index questionnaire (Neck surgery only)	Neck Disability Index questionnaire regarding levels of neck disability of subject	Up to 4 years
Other	Visual analog scale questionnaire	Visual analog scale questionnaire regarding pain levels	Up to 4 years
Other	Modified Japanese Orthopedic Association questionnaire (neck surgery only)	Modified Japanese Orthopedic Association questionnaire regarding motor disfunction levels	Up to 4 years
Other	Patient Satisfaction (neck surgery only)	Patient satisfaction questionnaire regarding satisfaction of neck surgery	Up to 4 years
Other	Scoliosis Research Society (SRS) 22r Survey	Scoliosis Research Society (SRS) 22r Survey regarding pain, mental health, and function of the subject.	Up to 4 years
Primary	Patient-Specific Hardware Spino-Pelvic Measurements	The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. Measurements are collected from the inferior endplate of the vertebral body C2 to the superior endplate of vertebral body S1 on the lateral view x-ray and from the superior endplate of vertebral body T1 to the superior endplate of vertebral body S1 in the Anteroposterior view x-ray.	Up to 4 years
Secondary	Non Patient-Specific Hardware Spino-Pelvic Measurements	The study will collect clinical and radiographic outcomes of patients implanted rods. Measurements are collected from the inferior endplate of the vertebral body C2 to the superior endplate of vertebral body S1 on the lateral view x-ray and from the superior endplate of vertebral body T1 to the superior endplate of vertebral body S1 in the Anteroposterior view x-ray.	1 year