MESA Rail™ AIS Study - Preservation of Curve Correction (NCT02062606) | Clinical Trial Compass
TerminatedNot Applicable
MESA Rail™ AIS Study - Preservation of Curve Correction
Stopped: The study terminated early due to slow enrollment that significantly extended the expected study duration.
188 participantsStarted 2014-05
Plain-language 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).
Who can participate
Age range11 Years – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ch…
What they're measuring
1
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