Scoliosis; AdolescenceNCT03843476
Personalized Spine Study Group Registry
An observational study of Scoliosis; Adolescence and Degenerative Disc Disease, run by Medicrea, USA Corp..
Trial summary
As a registry, the primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR. 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Sep 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patient is being implanted with patient specific rod
Who may be able to join
- Patient has been/ will be operated and instrumented with PSR from Medicrea
- Patient able to complete a self- administered questionnaires
- 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
About this study
As a registry, the primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR. The secondary objective is to collect clinical and radiographic outcomes of patients with Medicrea hardware as a control cohort to the patient-specific rods.
Read the detailed description
The registry will follow the patient during their standard of care visits. At each visit, the patient will answer questions about themselves and also fill out patient reported outcome sheets. Spinopelvic measurements will be obtained on the x-rays taken. This registry is observational only, and there is no driving hypothesis for data collection. Some broad topics of discussion are:
- Outcomes of patients sagittal profile through the pre-operative, plan and post-operative events
- Effectiveness of rod in conjunction with other surgical implants by measurements of fusion assessment and sagittal alignment
- Outcomes of patients in subgroups as defined by surgery performed, comorbidities, radiographic measurement, or other outcome variables
- Rod curvature maintenance over the follow-up period
- Understand 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
Also called UNiD Rod
Posterior spinal fusion rod
| Study group | Role | What they receive |
|---|---|---|
| Surgical with Rod | The patient is being treated with the patient specific rod with a surgery date planned Receives: Device: Patient Specific Rod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection initiative
The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR.
Measured: Up to 4 years
Secondary outcomes (1)
Collect clinical and radiographic outcomes of patients with Medicrea hardware
A control cohort to the patient-specific rods
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 posted18 Feb 2019
- Study startJan 2014
- Primary completionSep 2020
- Study completionSep 2020
Why it stopped: Requested by surgeons to pursue new study
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.
- 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
- 0 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Medicrea, USA Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843476
- Sponsor's protocol ID
- 1510
- Status last verified
- Sep 2020
- First submitted
- 4 Feb 2019
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Spine Study Group Registry
- ClinicalTrials.gov ID
- NCT03843476
- Acronym / sponsor ID
- 1510
- Conditions
- Scoliosis; Adolescence, Degenerative Disc Disease, Spinal Fusion, Kyphoscoliosis, Pseudoarthrosis of Spine, Spinal Stenosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Requested by surgeons to pursue new study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medicrea, USA Corp.Industry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 18 Feb 2019 (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.
As a registry, the primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR. The secondary objective is to collect clinical and radiographic outcomes of patients with Medicrea hardware as a control cohort to the patient-specific rods.
Detailed description
The registry will follow the patient during their standard of care visits. At each visit, the patient will answer questions about themselves and also fill out patient reported outcome sheets. Spinopelvic measurements will be obtained on the x-rays taken. This registry is observational only, and there is no driving hypothesis for data collection. Some broad topics of discussion are:
- Outcomes of patients sagittal profile through the pre-operative, plan and post-operative events
- Effectiveness of rod in conjunction with other surgical implants by measurements of fusion assessment and sagittal alignment
- Outcomes of patients in subgroups as defined by surgery performed, comorbidities, radiographic measurement, or other outcome variables
- Rod curvature maintenance over the follow-up period
- Understand the post-operative risks and complications from the pre-operative condition
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical with Rod | – | Device: Patient Specific RodThe patient is being treated with the patient specific rod with a surgery date planned |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient is being implanted with patient specific rod
Key inclusion criteria (3 listed)
- Patient has been/ will be operated and instrumented with PSR from Medicrea
- Patient able to complete a self- administered questionnaires
- 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 RodAlso: UNiD RodPosterior spinal fusion rod | Device | Surgical with Rod |
Primary outcome
Data collection initiative
Time frame: Up to 4 years
The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR.
1 secondary outcome
Collect clinical and radiographic outcomes of patients with Medicrea hardware
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis; Adolescence and Degenerative Disc Disease, run by Medicrea, USA Corp..
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 3 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: withdrawn, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection initiative (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 29 Sep 2020; AzTrials last refreshed its copy on 26 Oct 2026.