Scoliosis; AdolescencePSSGNCT04601363
Personalized Spine Study Group (PSSG) Registry
An observational study of Scoliosis; Adolescence and Degenerative Disc Disease, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 85 years
- Conditions the study is for
- Scoliosis; Adolescence, Degenerative Disc Disease, Spinal Fusion
- What is being tested?
- Patient Specific Rod
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2020to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population is implanted with either spine hardware or is undergoing surgery to have patient-specific rod implanted
Who may be able to join
- Patient has been/ will be operated and instrumented with patient-specific rod or spine hardware (control cohort)
- Patient able to consent or assent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dr. Christopher Kleck, MD
Aurora, Colorado, 80045
jiandong hao, 303-724-7457, jiandong.hao@cuanschutz.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Scoliosis; Adolescence, Degenerative Disc Disease, Spinal Fusion, Kyphoscoliosis, Pseudoarthrosis of Spine, Spinal Stenosis
- Being tested
- Patient Specific Rod
- Medical subject headings
- Scoliosis, Intervertebral Disc Degeneration, Spinal Stenosis, Scheuermann Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Specific RodDevice
Posterior spinal fusion rod
| Study group | Role | What they receive |
|---|---|---|
| Patients with Personalized SpineRods | The patient is being treated with the patient-specific rod with a surgery date planned Receives: Device: Patient Specific Rod | |
| Patient with other hardware | Patients with other hardware not patient-specific |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 years
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start29 Oct 2020
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Personalized Spine Study Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601363
- Sponsor's protocol ID
- 20-2016
- Acronym
- PSSG
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2020
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate data will be shared with the other investigators in the group
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Spine Study Group (PSSG) Registry of Patients With Personalized Spine Rod Implantation
- ClinicalTrials.gov ID
- NCT04601363
- Acronym / sponsor ID
- PSSG / 20-2016
- Conditions
- Scoliosis; Adolescence, Degenerative Disc Disease, Spinal Fusion, Kyphoscoliosis, Pseudoarthrosis of Spine, Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Personalized Spine Study Group
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Personalized SpineRods | – | Device: Patient Specific RodThe patient is being treated with the patient-specific rod with a surgery date planned |
| Patient with other hardware | – | –Patients with other hardware not patient-specific |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population is implanted with either spine hardware or is undergoing surgery to have patient-specific rod implanted
Key inclusion criteria (2 listed)
- Patient has been/ will be operated and instrumented with patient-specific rod or spine hardware (control cohort)
- Patient able to consent or assent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Specific RodPosterior spinal fusion rod | Device | Patients with Personalized SpineRods |
Primary outcome
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.
1 secondary outcome
Non Patient-Specific Hardware Spino-Pelvic Measurements
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No. Only aggregate data will be shared with the other investigators in the group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis; Adolescence and Degenerative Disc Disease, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Kleck, MD (720-848-1900, Christopher.Kleck@CUAnschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Specific Hardware Spino-Pelvic Measurements (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.