Adolescent Idiopathic ScoliosisNCT04296903
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)
A study testing MID-C System in people with Adolescent Idiopathic Scoliosis, run by Apifix at 14 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- MID-C System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 14 sitesUnited States
- Study dates
- 31 May 2020to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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 locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Wellstar
Atlanta, Georgia, 30060
University of Virginia
Charlottesville, Virginia, 22903
Rainbow babies and children
Cleveland, Ohio, 44106
Women and Children's Hospital - University of Missouri Health Care
Columbia, Missouri, 65201
Dayton Children's Hospital
Dayton, Ohio, 45404
Riley Children's Health
Indianapolis, Indiana, 46202
Univ. of Mississippi Medical Center (UMMC)
Jackson, Mississippi, 39216
Wolfson children's hospital
Jacksonville, Florida, 32207
Children's Mercy Hospital
Kansas City, Kansas, 64108
Mount Sinai hospital
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55902
Rady Children's Hospital
San Diego, California, 92123
Avera Health
Sioux Falls, South Dakota, 57105
Shriners Hospitals for Children
St Louis, Missouri, 63110
About this study
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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- MID-C System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MID-C SystemDevice
Minimal invasive deformity correction system for the treatment of AIS
| Study group | Role | What they receive |
|---|---|---|
| MID-C treatment | Experimental | Not described Receives: Device: MID-C System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of major Cobb angle ≤ 40° 5 years post-surgery
Spinal Cobb angle will be measured at 5 years post op. the percent of patients with Cobb angle ≤ 40° 5 years post-surgery will be calculated
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start31 May 2020
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apifix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296903
- Sponsor's protocol ID
- MID-C-AIS-03-18
- Status last verified
- Sep 2025
- First submitted
- 1 Mar 2020
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04296903
- Acronym / sponsor ID
- MID-C-AIS-03-18
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 201 participants (actual)
- Lead sponsor
- ApifixIndustry (pharma, biotech, devices)
- Study start
- 31 May 2020 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study
| Arm | Type | Receives |
|---|---|---|
| MID-C treatment | Experimental | Device: MID-C System |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MID-C SystemMinimal invasive deformity correction system for the treatment of AIS | Device | MID-C treatment |
Primary outcome
Maintenance of major Cobb angle ≤ 40° 5 years post-surgery
Time frame: 5 years
Spinal Cobb angle will be measured at 5 years post op. the percent of patients with Cobb angle ≤ 40° 5 years post-surgery will be calculated
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MID-C System in people with Adolescent Idiopathic Scoliosis, run by Apifix at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of major Cobb angle ≤ 40° 5 years post-surgery (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.