Adolescent Idiopathic ScoliosisNCT04684927
PMS Evaluation of Safety and Efficacy of the MID-C System 5 Years Post-implantation in AIS
A study testing MID-C System -Minimal invasive deformity correction system for the treatment of AIS in people with Adolescent Idiopathic Scoliosis, run by Apifix.
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 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- MID-C System -Minimal invasive deformity correction system for the treatment of AIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2021to 20 Mar 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves; 2.
- Patients with Risser stage 0-1, primary Cobb angle between 35-50 degrees (inclusive), or
- Patients with Risser stage 0-1 and good brace compliant but curve progression above 6°, or
- Patients with Risser stage 0-1 that are non-compliant with brace treatment and primary Cobb angle between 30-50 degrees or
- Patients with Risser stage 2, primary Cobb angle between 40-50 degrees (inclusive) 3. Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray; 4. Kyphosis angles of ≤ 45 degrees measured from T5 to T12; 5. Appropriate candidate for posterior surgical approach; 6. Patient has good general health; 7. Patient has no known hypersensitivity or allergies to titanium; 8. 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;
- Cumulative vertebral wedging over the apex of the curve>15º
- Known history of existing malignancy, or any systemic or local infection;
- Spinal cord abnormalities that require treatment;
- Known neurological deficit (defined as motor grades < 5/5);
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- Known poor bone quality defined as T score -1.5 or less;
- 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; and
- Systemic disease that would affect the patient's welfare or overall outcome of the study
About this study
Official title: Post-approval Study to Evaluate the Continued Safety and Efficacy of the MID-C System 5 Years Post-implantation in Adolescent Idiopathic Scoliosis (AIS)
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. A total of 10 patients, who are planned to undrego the MID-C System implantation procedure will be enrolled for the study. A 5 years follow-up post surgery will be performed for these patients in order to evaluate the long term safety and efficacy of the MID-C System.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- MID-C System -Minimal invasive deformity correction system for the treatment of AIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MID-C System -Minimal invasive deformity correction system for the treatment of AISDevice
A 5 years follow-up will be performed for all patients who underwent AIS repair surgery using the MID-C System. The follow-up in order to assess safety and efficacy measurments. Eligible Patients will be followed and assessed at the following time points: Immediate Post-op up to 6 weeks, 6 months, 12 months, and then annually out to 5 years post-implantation.
During the study, the following rating scales and assessments will be conducted to assess the probable benefit and safety of the treatment: Physical exam,X-rays,Cobb angle measurements,Adverse Events (AEs) and Scoliosis research society (SRS-22) questionnaire: The questionnaire is commonly used to assess health related quality of life in children with AIS.
| Study group | Role | What they receive |
|---|---|---|
| MID-C treatment | Experimental | Follow-up measurements during 5 years post MIC-C system implantationin order to evaluate safety and efficacy parameters. Receives: Device: MID-C System -Minimal invasive deformity correction system for the treatment of AIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint
Maintenance of major Cobb angle ≤ 30° 5 years post-surgery
Measured: 5 years post MID-C system implantation
Safety endpoint
Serious adverse events, and device or procedure-related adverse events
Measured: 5 years post MID-C system implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start20 Jan 2021 (estimated)
- Primary completion20 Jan 2028 (estimated)
- Study completion20 Mar 2028 (estimated)
Why it stopped: project not initiated
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
- The study is a prospective, single arm, non-randomized, new enrollment cohort study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apifix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684927
- Sponsor's protocol ID
- MID-C AIS 06-19
- Status last verified
- Feb 2021
- First submitted
- 22 Dec 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-approval Study to Evaluate the Continued Safety and Efficacy of the MID-C System 5 Years Post-implantation in Adolescent Idiopathic Scoliosis (AIS)
- ClinicalTrials.gov ID
- NCT04684927
- Acronym / sponsor ID
- MID-C AIS 06-19
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: project not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ApifixIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2021 (estimated)
- Primary completion
- 20 Jan 2028 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 28 Dec 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. A total of 10 patients, who are planned to undrego the MID-C System implantation procedure will be enrolled for the study. A 5 years follow-up post surgery will be performed for these patients in order to evaluate the long term safety and efficacy of the MID-C System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a prospective, single arm, non-randomized, new enrollment cohort study
| Arm | Type | Receives |
|---|---|---|
| MID-C treatment | Experimental | Device: MID-C System -Minimal invasive deformity correction system for the treatment of AISFollow-up measurements during 5 years post MIC-C system implantationin order to evaluate safety and efficacy parameters. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 1. Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves; 2.
- Patients with Risser stage 0-1, primary Cobb angle between 35-50 degrees (inclusive), or
- Patients with Risser stage 0-1 and good brace compliant but curve progression above 6°, or
- Patients with Risser stage 0-1 that are non-compliant with brace treatment and primary Cobb angle between 30-50 degrees or
- Patients with Risser stage 2, primary Cobb angle between 40-50 degrees (inclusive) 3. Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray; 4. Kyphosis angles of ≤ 45 degrees measured from T5 to T12; 5. Appropriate candidate for posterior surgical approach; 6. Patient has good general health; 7. Patient has no known hypersensitivity or allergies to titanium; 8. Patient's guardian signs a written informed consent form (ICF).
Key exclusion criteria (11 listed)
- Any type of non-idiopathic scoliosis;
- Any main thoracic deformity that includes vertebral levels and cranial including to T2;
- Cumulative vertebral wedging over the apex of the curve>15º
- Known history of existing malignancy, or any systemic or local infection;
- Spinal cord abnormalities that require treatment;
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 System -Minimal invasive deformity correction system for the treatment of AISA 5 years follow-up will be performed for all patients who underwent AIS repair surgery using the MID-C System. The follow-up in order to assess safety and efficacy measurments. Eligible Patients will be followed and assessed at the following time points: Immediate Post-op up to 6 weeks, 6 months, 12 months, and then annually out to 5 years post-implantation. During the study, the following rating scales and assessments will be conducted to assess the probable benefit and safety of the treatment: Physical exam,X-rays,Cobb angle measurements,Adverse Events (AEs) and Scoliosis research society (SRS-22) questionnaire: The questionnaire is commonly used to assess health related quality of life in children with AIS. | Device | MID-C treatment |
Primary outcome
Efficacy endpoint
Time frame: 5 years post MID-C system implantation
Maintenance of major Cobb angle ≤ 30° 5 years post-surgery
Safety endpoint
Time frame: 5 years post MID-C system implantation
Serious adverse events, and device or procedure-related adverse events
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing MID-C System -Minimal invasive deformity correction system for the treatment of AIS in people with Adolescent Idiopathic Scoliosis, run by Apifix.
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 5 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: withdrawn, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy endpoint (time frame: 5 years post MID-C system implantation). The study lists 2 primary outcomes in all. 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 10 Mar 2021.