Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Personalized Spine Study Group (PSSG) Registry (PSSG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 28, 2020
First Posted Date October 23, 2020
Last Update Posted Date June 4, 2021
Actual Study Start Date October 29, 2020
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 22, 2020)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 22, 2020)
  • PROMIS CAT Physical Function [ Time Frame: Up to 4 years ]
    Questionnaire regarding physical function of subject
  • PROMIS CAT Pain [ Time Frame: Up to 4 years ]
    Questionnaire regarding pain of subject
  • PROMIS CAT Anxiety [ Time Frame: Up to 4 years ]
    Questionnaire regarding anxiety of subject
  • PROMIS CAT Depression [ Time Frame: Up to 4 years ]
    Questionnaire regarding depression of subject
  • PROMIS CAT Satisfaction Activity Roles [ Time Frame: Up to 4 years ]
    Questionnaire regarding normal daily activity of subject
  • Oswestry Disability Index questionnaire (thoracic, thorocolumbar, lumbar surgery) [ Time Frame: Up to 4 years ]
    Oswestry Disability Index questionnaire regarding levels of disability of subject
  • Neck Disability Index questionnaire (Neck surgery only) [ Time Frame: Up to 4 years ]
    Neck Disability Index questionnaire regarding levels of neck disability of subject
  • Visual analog scale questionnaire [ Time Frame: Up to 4 years ]
    Visual analog scale questionnaire regarding pain levels
  • Modified Japanese Orthopedic Association questionnaire (neck surgery only) [ Time Frame: Up to 4 years ]
    Modified Japanese Orthopedic Association questionnaire regarding motor disfunction levels
  • Patient Satisfaction (neck surgery only) [ Time Frame: Up to 4 years ]
    Patient satisfaction questionnaire regarding satisfaction of neck surgery
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Personalized Spine Study Group (PSSG) Registry
Official Title Personalized Spine Study Group (PSSG) Registry of Patients With Personalized Spine Rod Implantation
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.
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
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Population is implanted with either spine hardware or is undergoing surgery to have patient-specific rod implanted
Condition
  • Scoliosis; Adolescence
  • Degenerative Disc Disease
  • Spinal Fusion
  • Kyphoscoliosis
  • Pseudoarthrosis of Spine
  • Spinal Stenosis
  • Kyphoses, Scheuermann
Intervention Device: Patient Specific Rod
Posterior spinal fusion rod
Study Groups/Cohorts
  • Patients with Personalized SpineRods
    The patient is being treated with the patient-specific rod with a surgery date planned
    Intervention: Device: Patient Specific Rod
  • Patient with other hardware
    Patients with other hardware not patient-specific
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 22, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2027
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christopher Kleck, MD 720-848-1900 Christopher.Kleck@CUAnschutz.edu
Contact: David Calabrese, MS 303-724-9265 David.Calabrese@cuanschutz.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04601363
Other Study ID Numbers 20-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Only aggregate data will be shared with the other investigators in the group
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Personalized Spine Study Group
Investigators Not Provided
PRS Account University of Colorado, Denver
Verification Date June 2021