Minimal Invasive Deformity Correction (MID-C) System for Early Onset Scoliosis

  • STATUS
    Recruiting
  • End date
    Jul 20, 2023
  • participants needed
    60
  • sponsor
    Apifix
Updated on 3 March 2022

Summary

Early Onset Scoliosis (EOS) is defined as scoliosis with onset under the age of ten years, regardless of etiology. It is a complex three-dimensional deformity of the spine which can cause significant physical and psychological problems. Currently there are two basic treatment options available for EOS: non-surgical and surgical. ApiFix Ltd. has developed a novel growing rod system for surgical treatment of EOS, the MID-C system. It is indicated for patients with a scoliosis of 35 to 75 degrees Cobb angle

Details
Condition Scoliosis, Scoliosis Idiopathic, Scoliosis;Congenital
Treatment MID-C
Clinical Study IdentifierNCT03519321
SponsorApifix
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with EOS aged 6-11 years, including idiopathic, syndromic, congenital and low tone neuromuscular diagnoses
Standing x-ray: a single major curve 8 vertebral segments, 35 to 75 degrees Cobb angle
Normal" or hypokyphotic sagittal contour (T5-T12 50 degrees)
Primary curve should be reduced to < 35 degrees Cobb angle on lateral bending/traction/stretch x-ray- the residual rigid segment must be 35 degrees
Patients with 25 degrees trunk rotation based on Scoliometer measurement
Subject in good general health
Subject and both subject's guardians/legal representatives are willing to sign a written informed consent form

Exclusion Criteria

EOS with more than one structural curve or a single curve involving more than 8 segments
High tone neuromuscular diagnoses
Primary curve cobb angle > 75 degrees
Kyphosis > 50 degrees
Previous scoliosis surgery
Neural axis abnormality observed by an MRI scan
Known allergy to titanium
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
Severely mentally compromised
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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