Scoliosis; AdolescenceNCT03609138
O-arm Assessment of Vertebral Movement Using ST2R Technique
An observational study of Scoliosis; Adolescence, run by Medicrea, USA Corp..
Trial summary
The study is quantifying how the patients' back has been corrected using Medicrea's hardware through imaging taken before,during and after the surgery. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Scoliosis; Adolescence
- What is being tested?
- Spinal Hardware
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jul 2022
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with adolescent idiopathic scoliosis undergoing fusion surgery
Who may be able to join
- Adolescent idiopathic scoliosis requiring selective thoracic posterior spinal instrumentation and fusion with the PASS LP system (screws, rods, hooks) and UNiD rod technology
- Age between 10 and 21
- Lenke Type 1 curve
- Consent and Assent to participate in the study
Who cannot join
- Age superior to 21 years
- Spinal deformities other than Lenke 1 type
- Use of implant other than those from the PASS LP system or sublaminar bands
- Neuromuscular or degenerative scoliosis
- Spinal cord abnormalities with any neurologic symptoms or signs
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
Show all 12Show fewer
- Primary muscle diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, Cerebral palsy, or Spina bidifa, Neurofibroma)
- Primary abnormalities of bones (e.g. osteogenesis imperfect)
- Congenital Scoliosis
- Scoliosis requiring anterior release
- Previous spinal surgery
- Absence of required preoperative data (diagnosis, consent…)
About this study
Official title: The O-arm Assessment of Vertebral Movement Pre and Post Correction Using ST2R Technique
The study is quantifying how the patients' back has been corrected using Medicrea's hardware through imaging taken before,during and after the surgery.
Read the detailed description
Visits include the pre-operative visit, 1 and 2 year follow-up visits. Participation includes answering questions and filling out questionnaires. There are no immediate benefits by joining this study, but could potentially help define better techniques for the future spine surgeries. The risks involved in this study are minimal and there are no alternatives to this study.
- Conditions
- Scoliosis; Adolescence
- Being tested
- Spinal Hardware
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal HardwareDevice
Pedicle screws and patient specific rods
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Not described Receives: Device: Spinal Hardware |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients
Measured: 4 years
Secondary outcomes (1)
Assess 3 dimensional correction pre- and post- correction using x-rays and O-arm data
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study startJul 2018 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Study aborted
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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicrea, USA Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609138
- Sponsor's protocol ID
- #0312
- Status last verified
- Nov 2023
- First submitted
- 24 Jul 2018
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The O-arm Assessment of Vertebral Movement Pre and Post Correction Using ST2R Technique
- ClinicalTrials.gov ID
- NCT03609138
- Acronym / sponsor ID
- #0312
- Conditions
- Scoliosis; Adolescence
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study aborted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medicrea, USA Corp.Industry (pharma, biotech, devices)
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 1 Aug 2018 (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 study is quantifying how the patients' back has been corrected using Medicrea's hardware through imaging taken before,during and after the surgery.
Detailed description
Visits include the pre-operative visit, 1 and 2 year follow-up visits. Participation includes answering questions and filling out questionnaires. There are no immediate benefits by joining this study, but could potentially help define better techniques for the future spine surgeries. The risks involved in this study are minimal and there are no alternatives to this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Device: Spinal Hardware |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with adolescent idiopathic scoliosis undergoing fusion surgery
Key inclusion criteria (4 listed)
- Adolescent idiopathic scoliosis requiring selective thoracic posterior spinal instrumentation and fusion with the PASS LP system (screws, rods, hooks) and UNiD rod technology
- Age between 10 and 21
- Lenke Type 1 curve
- Consent and Assent to participate in the study
Key exclusion criteria (12 listed)
- Age superior to 21 years
- Spinal deformities other than Lenke 1 type
- Use of implant other than those from the PASS LP system or sublaminar bands
- Neuromuscular or degenerative scoliosis
- Spinal cord abnormalities with any neurologic symptoms or signs
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 |
|---|---|---|
| Spinal HardwarePedicle screws and patient specific rods | Device | Study Cohort |
Primary outcome
Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients
Time frame: 4 years
1 secondary outcome
Assess 3 dimensional correction pre- and post- correction using x-rays and O-arm data
Time frame: 4 years
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 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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, 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 4 inclusion and 12 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 Nov 2023. 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?
Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients (time frame: 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 Nov 2023.