Personalized Spine Study Group (PSSG) Registry

NCT04601363 | Recruiting

• 1 other identifier: 20-2016
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Adolescence; Degenerative Disc Disease; Spinal Fusion; Kyphoscoliosis; Pseudoarthrosis of Spine; Spinal Stenosis; Kyphoses, Scheuermann

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Non Patient-Specific Hardware Spino-Pelvic Measurements

  1 year

Other Outcomes (11)

• PROMIS CAT Physical Function

  Up to 4 years

• PROMIS CAT Pain

  Up to 4 years

• PROMIS CAT Anxiety

  Up to 4 years

Study Arms (2)

Patients with Personalized SpineRods

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

Device: Patient Specific Rod

Patient with other hardware

Patients with other hardware not patient-specific

Interventions

Patient Specific Rod DEVICE

Posterior spinal fusion rod

Patients with Personalized SpineRods

Eligibility Criteria

• Age: 10 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient has been/ will be operated and instrumented with patient-specific rod or spine hardware (control cohort)
• Patient able to consent or assent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Personalized Spine Study Group: collaborator

Study Sites (1)

Dr. Christopher Kleck, MD

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Scoliosis; Intervertebral Disc Degeneration; Spinal Stenosis; Scheuermann Disease

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Osteochondrosis; Osteochondrosis; Kyphosis

Central Study Contacts

Christopher Kleck, MD

CONTACT

720-848-1900; Christopher.Kleck@CUAnschutz.edu

jiandong hao

CONTACT

303-724-7457; jiandong.hao@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 23, 2020
• Study Start: October 29, 2020
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)