Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity
NCT ID: NCT02590380
Last Updated: 2021-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-09-30
2030-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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treatment group (MESA)
Patients randomized to the treatment group will receive surgery with the MESA Rail Deformity System.
MESA Rail Deformity System
The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the MESA Rail Deformity System.
control group (USS II)
Patients randomized to the control group will receive surgery with the DePuy Synthes USS II System.
DePuy Synthes USS II System
The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the DePuy Synthes USS II system.
Interventions
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MESA Rail Deformity System
The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the MESA Rail Deformity System.
DePuy Synthes USS II System
The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the DePuy Synthes USS II system.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Willingness and ability to comply with the requirements of the protocol including follow-up requirements.
3. Willing and able to sign a study specific informed consent form or, in the case of a patient who is a minor, provide assent and the minor patient's parent/legal guardian provides written consent to participate.
4. Age range of ≥ 11 years old and ≤ 21 years old at time of surgery.
Exclusion Criteria
2. Previous posterior spine surgery (e.g., posterior element decompression) that destabilizes the cervical/thoracic/lumbar spine.
3. Active systemic infection or infection at the operative site.
4. Any sign of any spinal dysrhaphism (any cord abnormality).
5. Co-morbid medical conditions of the spine or upper/lower extremities that may affect the thoracic or lumbar spine neurological and/or pain assessment.
6. Metabolic bone disease such as osteoporosis that contradicts spinal surgery.
7. History of an osteoporotic fracture.
8. History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.
9. Taking medications that may interfere with bony/soft tissue healing including chronic oral steroid use.
10. Known allergy to titanium or cobalt chrome.
11. Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.
12. Insulin-dependent type 1 or type 2 diabetes.
13. Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion.
14. Pregnant, or intend to become pregnant, during the course of the study.
15. Severe obesity (Body Mass Index \> 40).
16. Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life.
17. Incarcerated at the time of study enrollment.
18. Current participation in an investigational study that may impact study outcomes.
11 Years
21 Years
ALL
No
Sponsors
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K2M, Inc.
INDUSTRY
Responsible Party
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Locations
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University Hospital Southampton
Southampton, , United Kingdom
Countries
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Other Identifiers
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CAS-029
Identifier Type: -
Identifier Source: org_study_id