MESA Rail™ AIS Study - Preservation of Curve Correction

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2020-02-23

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AIS

Surgical implantation of the K2M MESA Rail™ Deformity System in the treatment of Adolescent Idiopathic Scoliosis (AIS).

MESA Rail™ Deformity System

Intervention Type DEVICE

MESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature

Interventions

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MESA Rail™ Deformity System

MESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

11 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No