Clinical trial NCT03519321: Minimal Invasive Deformity Correction (MID-C) System for Early Onset Scoliosis
Official title: Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Early Onset Scoliosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scoliosis
Scoliosis Idiopathic
Scoliosis;Congenital
Keywords: Early Onset Scoliosis (EOS)
Lead sponsor: Apifix
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Patients with EOS aged 6-11 years, including idiopathic, syndromic, congenital and low tone neuromuscular diagnoses.
2. Standing x-ray: a single major curve ≤ 8 vertebral segments, 35 to 75 degrees Cobb angle
3. "Normal" or hypokyphotic sagittal contour (T5-T12 ≤ 50⁰ degrees)
4. 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
5. Patients with ≤ 25 degrees trunk rotation based on Scoliometer measurement
6. Subject in good general health
7. Subject and both subject's guardians/legal representatives are willing to sign a written informed consent form

Exclusion Criteria:

1. EOS with more than one structural curve or a single curve involving more than 8 segments
2. High tone neuromuscular diagnoses
3. Primary curve cobb angle \> 75 degrees
4. Kyphosis \> 50 degrees
5. Previous scoliosis surgery
6. Neural axis abnormality observed by an MRI scan
7. Known allergy to titanium
8. Active systemic disease, such as AIDS, HIV, or active infection
9. Systemic disease that would affect the subject's welfare or overall outcome of the study.
10. Severely mentally compromised

Primary outcomes:
measure: Maintenance of the major curvature ≤ 50 degrees at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: No progression of the primary curve ≥ 10 degrees Cobb angle from correction at time of surgery over time at all follow-up visits
timeFrame: 6 months, 12 months, 24 months
measure: No progression of the secondary (compensatory) curves ≥ 50 degrees Cobb angle over time at all follow-up visits
timeFrame: 6 months, 12 months, 24 months
measure: Blood loss during surgery
timeFrame: Baseline - week 0
measure: Duration of surgery
timeFrame: Baseline - week 0
measure: Duration of hospitalisation
timeFrame: Baseline - week 0
measure: Number of reoperations
timeFrame: 6 Weeks, 3 months, 6 months, 12 months, 24 months
Other outcomes:
measure: Device related serious adverse events
timeFrame: 6 Weeks, 3 months, 6 months, 12 months, 24 months
Locations:
city: Athens
country: Greece
facility: Paidon Pentelis Hospital
Study officials:
affiliation: Chief of Orthopaedics. IWK Health Centre.Associate Professor, Dpt. of Surgery, Dalhousie University, Canada
name: Ron El-Hawary, MD
role: STUDY_DIRECTOR
affiliation: Spine surgeon
name: Ioanna Paspati, MD
role: PRINCIPAL_INVESTIGATOR
References: