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NCT Number: NCT04601363

Personalized Spine Study Group (PSSG) Registry

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.

Recruiting

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Key information

Age range

10 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Christopher Kleck, MD

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

jiandong hao

CONTACT

[email protected]

303-724-7457

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Specific Rod

Device

Posterior spinal fusion rod

Primary outcomes

  1. Patient-Specific Hardware Spino-Pelvic Measurements

    Time frame: Up to 4 years

    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.

Secondary outcomes

  1. Non Patient-Specific Hardware Spino-Pelvic Measurements

    Time frame: 1 year

    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.

Other outcomes

  1. PROMIS CAT Physical Function

    Time frame: Up to 4 years

    Questionnaire regarding physical function of subject

  2. PROMIS CAT Pain

    Time frame: Up to 4 years

    Questionnaire regarding pain of subject

  3. PROMIS CAT Anxiety

    Time frame: Up to 4 years

    Questionnaire regarding anxiety of subject

  4. PROMIS CAT Depression

    Time frame: Up to 4 years

    Questionnaire regarding depression of subject

  5. PROMIS CAT Satisfaction Activity Roles

    Time frame: Up to 4 years

    Questionnaire regarding normal daily activity of subject

  6. Oswestry Disability Index questionnaire (thoracic, thorocolumbar, lumbar surgery)

    Time frame: Up to 4 years

    Oswestry Disability Index questionnaire regarding levels of disability of subject

  7. Neck Disability Index questionnaire (Neck surgery only)

    Time frame: Up to 4 years

    Neck Disability Index questionnaire regarding levels of neck disability of subject

  8. Visual analog scale questionnaire

    Time frame: Up to 4 years

    Visual analog scale questionnaire regarding pain levels

  9. Modified Japanese Orthopedic Association questionnaire (neck surgery only)

    Time frame: Up to 4 years

    Modified Japanese Orthopedic Association questionnaire regarding motor disfunction levels

  10. Patient Satisfaction (neck surgery only)

    Time frame: Up to 4 years

    Patient satisfaction questionnaire regarding satisfaction of neck surgery

  11. Scoliosis Research Society (SRS) 22r Survey

    Time frame: Up to 4 years

    Scoliosis Research Society (SRS) 22r Survey regarding pain, mental health, and function of the subject.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Kleck, MD

CONTACT

[email protected]

720-848-1900

jiandong hao

CONTACT

[email protected]

303-724-7457

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Personalized Spine Study Group

Registry information

Official study title

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

Acronym: PSSG

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Oct 23, 2020
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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