Feasibility Evaluation Study of the MID-C Device
Condition: Adolescent Idiopathic Scoliosis (AIS)
MeSH terms: Scoliosis
Study type: Observational [Patient Registry]

Summary: 
      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.
    

Detailed description: 
      The study is designed as an observational study with a 24-month follow-up period. Consecutive
      patients undergoing treatment of AIS by the MID-C system in daily practice will be included
      during a 24-month enrollment period.
    

Intervention name(s): MID-C
Intervention type(s): Device
Intervention description(s): The MID-C system is designed to correct the deformity step by step along a period of time, giving the skeletal and soft tissues 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 complication thanks to the three points above.
Minimal spinal mobility loss
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.