ScoliosisNCT03519321
Minimal Invasive Deformity Correction (MID-C) System for Early Onset Scoliosis
A study testing MID-C in people with Scoliosis and Scoliosis Idiopathic, run by Apifix at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Scoliosis, Scoliosis Idiopathic, Scoliosis;Congenital
- What is being tested?
- MID-C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 11 Apr 2018to 20 Jul 2023
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 ≤ 50⁰ 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Uri Arnin contact
Greece1 site, 1 recruiting
- Recruiting
Paidon Pentelis Hospital
Athens
Ionna Paspati, MD, 697465770, ipaspati@yahoo.com
About this study
Official title: Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Early Onset Scoliosis
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
- Conditions
- Scoliosis, Scoliosis Idiopathic, Scoliosis;Congenital
- Being tested
- MID-C
- Keywords
- Early Onset Scoliosis (EOS)
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MID-CDevice
The MID-C system is being connected to the spine via standard unilateral posterior approach. Pedicle screws above and below the main curve are being used to attach the device to the selected vertebra.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | MID-C EOS implant will be implanted for the correction of the spine deformity in children found eligible for the study Receives: Device: MID-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of the major curvature ≤ 50 degrees at 24 months
curve progression will be evaluated by X-ray as in the standard of care
Measured: 24 months
Secondary outcomes (6)
No progression of the primary curve ≥ 10 degrees Cobb angle from correction at time of surgery over time at all follow-up visits
curve progression will be evaluated by X-ray as in the standard of care
Measured: 6 months, 12 months, 24 months
No progression of the secondary (compensatory) curves ≥ 50 degrees Cobb angle over time at all follow-up visits
curve progression will be evaluated by X-ray as in the standard of care
Measured: 6 months, 12 months, 24 months
Blood loss during surgery
Data will be collected from the hospital surgery records
Measured: Baseline - week 0
Duration of surgery
Data will be collected from the hospital surgery records
Measured: Baseline - week 0
Duration of hospitalisation
Data will be collected from the hospital records
Measured: Baseline - week 0
Number of reoperations
in case the patient requires a re-operation it will be documented in the study CRF
Measured: 6 Weeks, 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start11 Apr 2018
- Primary completion20 Jun 2023 (estimated)
- Study completion20 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apifix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron El-Hawary, MD, Study director, Chief of Orthopaedics. IWK Health Centre.Associate Professor, Dpt. of Surgery, Dalhousie University, CanadaIoanna Paspati, MD, Principal investigator, Spine surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519321
- Sponsor's protocol ID
- AF-MID-C-EOS 01-16
- Status last verified
- Jul 2021
- First submitted
- 25 Apr 2018
- Last updated
- 22 Jul 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 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Early Onset Scoliosis
- ClinicalTrials.gov ID
- NCT03519321
- Acronym / sponsor ID
- AF-MID-C-EOS 01-16
- Conditions
- Scoliosis, Scoliosis Idiopathic, Scoliosis;Congenital
- Keywords
- Early Onset Scoliosis (EOS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ApifixIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 20 Jun 2023 (estimated)
- Study completion
- 20 Jul 2023 (estimated)
- First posted
- 8 May 2018 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: MID-CMID-C EOS implant will be implanted for the correction of the spine deformity in children found eligible for the study |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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 ≤ 50⁰ 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
Key exclusion criteria (10 listed)
- 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
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-CThe MID-C system is being connected to the spine via standard unilateral posterior approach. Pedicle screws above and below the main curve are being used to attach the device to the selected vertebra. | Device | Treatment |
Primary outcome
Maintenance of the major curvature ≤ 50 degrees at 24 months
Time frame: 24 months
curve progression will be evaluated by X-ray as in the standard of care
6 secondary outcomes
No progression of the primary curve ≥ 10 degrees Cobb angle from correction at time of surgery over time at all follow-up visits
Time frame: 6 months, 12 months, 24 months
No progression of the secondary (compensatory) curves ≥ 50 degrees Cobb angle over time at all follow-up visits
Time frame: 6 months, 12 months, 24 months
Blood loss during surgery
Time frame: Baseline - week 0
Duration of surgery
Time frame: Baseline - week 0
Duration of hospitalisation
Time frame: Baseline - week 0
Number of reoperations
Time frame: 6 Weeks, 3 months, 6 months, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Scoliosis
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS
Adolescent Idiopathic Scoliosis (AIS)
Active, not recruitingObservational study
Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening With Momentum SpineTM
Adolescent Idiopathic Scoliosis
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.
Uri Arnin contact
Ron El-Hawary, MD study director
Chief of Orthopaedics. IWK Health Centre.Associate Professor, Dpt. of Surgery, Dalhousie University, Canada
Ioanna Paspati, MD principal investigator
Spine surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MID-C in people with Scoliosis and Scoliosis Idiopathic, run by Apifix at 1 site in Greece.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daphna Zaaroor Regev, PhD (+972-523763653, Daphna@apifix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of the major curvature ≤ 50 degrees at 24 months (time frame: 24 months). 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 22 Jul 2021.