Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)

Study Purpose

The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	10 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves; - Cobb angle between 35-60 degrees (inclusive); - Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray; - Kyphosis angles of ≤ 55 degrees measured from T5 to T12; - Appropriate candidate for posterior surgical approach; - Patient has good general health; - Patient has no known hypersensitivity or allergies to titanium; - Patient's guardian signs a written informed consent form (ICF).

Exclusion Criteria:

- Any type of non-idiopathic scoliosis; - Any main thoracic deformity that includes vertebral levels and cranial including to T2; - Known history of existing malignancy, or any systemic or local infection; - Spinal cord abnormalities that require treatment; - Known neurological deficit (defined as motor grade < 5/5); - Known poor bone quality defined as T score -1.5 or less; - For female Patient, pregnancy; - Previous spine surgery that would prevent the successful performance of the MID-C system ; - Active systemic disease, such as AIDS, HIV, or active infection; - Active infection or the skin is compromised at the surgical site; - Systemic disease that would affect the Patient's welfare or overall outcome of the study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04296903
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Apifix
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Adolescent Idiopathic Scoliosis

Arms & Interventions

Arms

Experimental: MID-C treatment

Interventions

Device: - MID-C System

Minimal invasive deformity correction system for the treatment of AIS

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix Children's Hospital, Phoenix, Arizona

Status

Withdrawn

Address

Phoenix Children's Hospital

Phoenix, Arizona, 85016

Site Contact

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