Personalized Spine Study Group (PSSG) Registry (PSSG)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Spinal Stenosis; Spinal Fusion; Kyphoscoliosis; Scoliosis; Adolescence; Pseudoarthrosis of Spine; Kyphoses, Scheuermann
• Intervention / Treatment: Device: Patient Specific Rod

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Christopher Kleck, MD; Phone Number: 720-848-1900; Email: Christopher.Kleck@CUAnschutz.edu
• Study Contact Backup: Name: Jiandong Hao; Phone Number: 303-724-7457; Email: Jiandong.Hao@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Dr. Christopher Kleck, MD
      • Contact: Jiandong Hao; Phone Number: 303-724-7457; Email: Jiandong.Hao@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Population is implanted with either spine hardware or is undergoing surgery to have patient-specific rod implanted

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Personalized SpineRods; The patient is being treated with the patient-specific rod with a surgery date planned	Device: Patient Specific Rod; Posterior spinal fusion rod
Patient with other hardware; Patients with other hardware not patient-specific

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS CAT Physical Function	Questionnaire regarding physical function of subject	Up to 4 years
PROMIS CAT Pain	Questionnaire regarding pain of subject	Up to 4 years
PROMIS CAT Anxiety	Questionnaire regarding anxiety of subject	Up to 4 years
PROMIS CAT Depression	Questionnaire regarding depression of subject	Up to 4 years
PROMIS CAT Satisfaction Activity Roles	Questionnaire regarding normal daily activity of subject	Up to 4 years
Oswestry Disability Index questionnaire (thoracic, thorocolumbar, lumbar surgery)	Oswestry Disability Index questionnaire regarding levels of disability of subject	Up to 4 years
Neck Disability Index questionnaire (Neck surgery only)	Neck Disability Index questionnaire regarding levels of neck disability of subject	Up to 4 years
Visual analog scale questionnaire	Visual analog scale questionnaire regarding pain levels	Up to 4 years
Modified Japanese Orthopedic Association questionnaire (neck surgery only)	Modified Japanese Orthopedic Association questionnaire regarding motor disfunction levels	Up to 4 years
Patient Satisfaction (neck surgery only)	Patient satisfaction questionnaire regarding satisfaction of neck surgery	Up to 4 years
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Personalized Spine Study Group

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Osteochondrosis; Fractures, Ununited; Scoliosis; Intervertebral Disc Degeneration; Spinal Stenosis; Kyphosis; Scheuermann Disease; Spinal Osteochondrosis; Pseudarthrosis
• Other Study ID Numbers: 20-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregate data will be shared with the other investigators in the group

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No