Clinical trial NCT02590380: Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity
Official title: A Randomized Controlled Trial: Comparison of a Top Loading MESA® Spinal System With MESA Rail™ and a Side Locking Pedicle Screw System for the Treatment of Adolescent Paediatric Spine Deformity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Adolescent
paediatric
pediatric
scoliosis
spine deformity
Lead sponsor: K2M, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-29
Enrollment: 0
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the efficacy of the K2M MESA Rail™ Deformity System at improving coronal and sagittal correction of the adolescent idiopathic spine deformity in comparison to the side loading DePuy Synthes USS II pedicle screw system.

Detailed description: Evaluation of the efficacy of the K2M MESA Rail™ Deformity System at improving coronal and sagittal correction of the adolescent idiopathic spine deformity in comparison to the side loading DePuy Synthes USS II pedicle screw system. This is a single-center, single-surgeon randomized controlled trial with follow-up evaluations of patients conducted at initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure. Adverse events will be monitored continuously.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Adolescent Idiopathic Scoliosis (AIS) with no associated syndrome requiring surgical treatment for selective thoracic/lumbar fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve. No cervical vertebrae are to be incorporated into the construct.
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:

1. Previous anterior or posterior spine surgery at the index levels.
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.

Primary outcomes:
measure: Correction and Maintenance of Spinal Deformity (coronal)
timeFrame: Change from pre-operative to 3 months, 12 months and 24 months post-procedure
measure: Correction and Maintenance of Spinal Deformity (sagittal)
timeFrame: Change from pre-operative to 3 months, 12 months and 24 months post-procedure
Secondary outcomes:
measure: Back and Leg Pain 10cm Visual Analog Scale (VAS)
timeFrame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
measure: SRS-22
timeFrame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
measure: Estimated Blood Volume Loss/Salvage Return
timeFrame: Operative Data - to be collected immediately after case is completed. Estimated blood loss will be noted by the surgical/anesthesia team and this value can then be immediately collected.
measure: Length of Hospital Stay
timeFrame: At discharge (up to one week post surgery) - Once the subject has been released from the hospital, the length of hospital stay can be calculated using the intake and discharge dates.
measure: Return to Work/School
timeFrame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
measure: Return to Sport/Physical Activity
timeFrame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
measure: Use of Analgesia Post-Surgery
timeFrame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
References: