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Personalized Spine Study Group (PSSG) Registry (PSSG)

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ClinicalTrials.gov Identifier: NCT04601363
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : June 4, 2021
Sponsor:
Collaborator:
Personalized Spine Study Group
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment
Scoliosis; Adolescence Degenerative Disc Disease Spinal Fusion Kyphoscoliosis Pseudoarthrosis of Spine Spinal Stenosis Kyphoses, Scheuermann 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Personalized Spine Study Group (PSSG) Registry of Patients With Personalized Spine Rod Implantation
Actual Study Start Date : October 29, 2020
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2027

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601363


Contacts
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Contact: Christopher Kleck, MD 720-848-1900 Christopher.Kleck@CUAnschutz.edu
Contact: David Calabrese, MS 303-724-9265 David.Calabrese@cuanschutz.edu

Locations
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United States, Colorado
Dr. Christopher Kleck, MD Recruiting
Aurora, Colorado, United States, 80045
Contact: David Calabrese    303-724-2550    David.Calabrese@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
Personalized Spine Study Group
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04601363    
Other Study ID Numbers: 20-2016
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only aggregate data will be shared with the other investigators in the group

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scoliosis
Spinal Stenosis
Intervertebral Disc Degeneration
Kyphosis
Scheuermann Disease
Spinal Osteochondrosis
Pseudarthrosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Fractures, Ununited
Fractures, Bone
Wounds and Injuries
Osteochondrosis