Clinical trial NCT02062606: MESA Rail™ AIS Study - Preservation of Curve Correction
Official title: Preservation of Thoracic Kyphosis and Coronal Curve Correction as a Function of Rod Stiffness in the Surgical Treatment of Adolescent Idiopathic Scoliosis (AIS) With the Use of the K2M MESA Rail™ Deformity System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis
Spinal Curvatures
Spinal Diseases
Adolescent Idiopathic Scoliosis
Spinal Deformity
Lead sponsor: K2M, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-13
Enrollment: 188
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two-hundred four (204) total subjects with the MESA Rail Deformity System at up to 18 clinical sites, geographically distributed worldwide.

Brief summary: To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod systems in the treatment of Adolescent Idiopathic Scoliosis (AIS).

Detailed description: Patients treated with the Ø5.5mm or Ø4.5mm MESA Rail™ Deformity System that had:

Diagnosis of AIS requiring surgical treatment for selective non-cervical 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 (lumbar modifiers and thoracic sagittal profiles will be noted but not restrictive).

Age at time of surgery of ≥ 11 years old and ≤ 21 years old.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of AIS 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.
* Willingness and ability to comply with the requirements of the protocol including follow-up requirements.
* 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.
* Age range of ≥ 11 years old and ≤ 21 years old at time of surgery.

Exclusion Criteria:

* Previous anterior or posterior spine surgery at the index levels.
* Previous posterior spine surgery (e.g., posterior element decompression) that destabilizes the cervical/thoracic/lumbar spine.
* Active systemic infection or infection at the operative site.
* Co-morbid medical conditions of the spine or upper/lower extremities that may affect the thoracic or lumbar spine neurological and/or pain assessment.
* Metabolic bone disease such as osteoporosis that contradicts spinal surgery.
* History of an osteoporotic fracture.
* History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.
* Taking medications that may interfere with bony/soft tissue healing including chronic steroid use.
* Known allergy to titanium or cobalt chrome.
* Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.
* Insulin-dependent type 1 or type 2 diabetes.
* Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion.
* Pregnant, or intend to become pregnant, during the course of the study.
* Severe obesity (Body Mass Index \> 40).

Primary outcomes:
measure: Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months
timeFrame: Baseline (up to 90 days before surgery), 24 months
measure: Number of Participants With Adverse Events
timeFrame: Up to 24 months
Secondary outcomes:
measure: Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months
timeFrame: Baseline (up to 90 days before surgery), 24 months
measure: Change From Baseline in Quality of Life Scores on the SRS-22r at 24 Months
timeFrame: Baseline (up to 90 days before surgery), 24 months
measure: Patient Satisfaction
timeFrame: 12 months and 24 months
measure: Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria
timeFrame: 24 months
measure: Length of Surgery Time
timeFrame: During surgery
measure: Length of Anesthesia Time
timeFrame: During surgery
measure: Estimated Blood Loss
timeFrame: During surgery
measure: Length of Hospital Stay
timeFrame: Admission to Discharge
measure: Change in Percentage of Participants Able to Return to Work/School
timeFrame: Pre-Op to 24 months
measure: Use of Narcotics Post-surgery
timeFrame: Pre-Op to 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: Wattenbarger JM, Richards BS, Herring JA. A comparison of single-rod instrumentation with double-rod instrumentation in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2000 Jul 1;25(13):1680-8. doi: 10.1097/00007632-200007010-00011.
citation: Newton PO, Yaszay B, Upasani VV, Pawelek JB, Bastrom TP, Lenke LG, Lowe T, Crawford A, Betz R, Lonner B; Harms Study Group. Preservation of thoracic kyphosis is critical to maintain lumbar lordosis in the surgical treatment of adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2010 Jun 15;35(14):1365-70. doi: 10.1097/BRS.0b013e3181dccd63.
citation: Kim YJ, Lenke LG, Bridwell KH, Kim J, Cho SK, Cheh G, Yoon J. Proximal junctional kyphosis in adolescent idiopathic scoliosis after 3 different types of posterior segmental spinal instrumentation and fusions: incidence and risk factor analysis of 410 cases. Spine (Phila Pa 1976). 2007 Nov 15;32(24):2731-8. doi: 10.1097/BRS.0b013e31815a7ead.