Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Adolescent Idiopathic Scoliosis (AIS)
Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Adolescent Idiopathic Scoliosis (AIS)
Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the
 vertebrae and discs gradually develop a curvature that is first detected in patients between
 11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from
 radiographs by the Cobb angle .

 The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each
 vertebra and disc between the superior and inferior end vertebrae . Although a small curve is
 well tolerated and does not require treatment, a large curve can progress to the point that
 it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac
 and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the
 initiation of the curve and its subsequent progression. The factors responsible for the
 initiation of the curve are unknown, but the subsequent progression of the curve is clearly
 associated with the adolescent growth spurt . The primary risk factors for progression
 include age at onset and the magnitude of the curve; young patients with large curves are at
 the highest risk .

 Although numerous treatment methods have been recommended for patients with AIS, the only
 accepted treatment includes bracing for skeletally immature patients with curves between 25
 and 40 degrees and operative correction with spinal fusion for patients with curves greater
 than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing
 has caused compliance problems with wearing the brace and many patients only wear the brace
 at home . While operative intervention completely corrects the scoliosis or rib hump, it
 eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion
 potentially leading to disc degeneration and back pain.

 Despite satisfactory short-term results of operative instrumentation and fusion, a less
 invasive technique preserving more motion with a smaller scar represents a major improvement.
 Realizing this goal is contingent on treating curves early, before they progress to an
 irreversible deformity, and when there is still enough residual growth and remodeling
 potential.

 ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system
 is designed to correct the deformity step by step along a period of time, giving the skeletal
 and soft tissues time to accommodate any incremental correction.

 The MID-C System inherent benefits are:

 -  Only two screws are used

 -  Incision size is much smaller

 -  Simpler operation with shorter operative time

 -  Less complications (attributed to the three points above).

 -  Minimal spinal mobility loss.

 All the device components are made of materials well accepted in the orthopedic field and are
 fully biocompatible (see Investigator Brochure).

 The unique concept of the system and the materials used may provide favorable results as
 follows: Smaller scare, quicker healing period and better spine mobility over the years.

 This study is designed to demonstrate that the MID-C System is safe and effective.
The study is designed as a European, observational study with a 12-month follow-up period.
 Consecutive patients undergoing treatment of AIS by the MID-C system in daily practice will
 be included during a 6-month enrollment period.
Inclusion Criteria:

 -  11≤ Adolescents < 20 years old

 -  Patient undergoing treatment of AIS by the MID-C system in daily practice

 -  Minimum of 35 degrees Cobb angle, confirmed by X-ray. Lenke type 1 or 5

 -  Flexible major curve, correction to below 30° at lateral bending.

 -  Risser sign of 1 to 5

 -  Appropriate candidate for posterior surgical approach as determined by surgeon

 -  Subject has good general health as determined by physician.

 -  Subject has no known hypersensitivity and allergies to Titanium

 -  Subject's guardian willing to sign a written Informed Consent Form (ICF)

 Exclusion Criteria:

 -  Cobb angle over 60 degrees

 -  Other non-idiopathic scoliosis.

 -  AIS which is not defined as Lenke type 1 or 5

 -  Previous spine surgery.

 -  Known allergy to any component of the device.

 -  Known active systemic disease, such as AIDS, HIV, or active infection

 -  Systemic disease that would affect the subject's welfare or overall outcome of the
 study as determined by the physician.

 -  Mentally compromised as determined by the physician