Minimal Invasive Deformity Correction (MID-C) System for Early Onset Scoliosis

Not Applicable

• Conditions: Scoliosis;Congenital; Scoliosis Idiopathic; Scoliosis
• Interventions: Device: MID-C

• Registration Number: NCT03519321
• Lead Sponsor: Apifix

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-11
• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-05-07
• Study First Posted: 2018-05-08
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22
• Primary Completion: 2023-06-20
• Study Completion: 2023-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	MID-C	MID-C EOS implant will be implanted for the correction of the spine deformity in children found eligible for the study

Primary Outcome Measures

Name	Time	Method
Maintenance of the major curvature ≤ 50 degrees at 24 months	24 months	curve progression will be evaluated by X-ray as in the standard of care

Secondary Outcome Measures

Name	Time	Method
Blood loss during surgery	Baseline - week 0	Data will be collected from the hospital surgery records
Duration of surgery	Baseline - week 0	Data will be collected from the hospital surgery records
No progression of the primary curve ≥ 10 degrees Cobb angle from correction at time of surgery over time at all follow-up visits	6 months, 12 months, 24 months	curve progression will be evaluated by X-ray as in the standard of care
Duration of hospitalisation	Baseline - week 0	Data will be collected from the hospital records
No progression of the secondary (compensatory) curves ≥ 50 degrees Cobb angle over time at all follow-up visits	6 months, 12 months, 24 months	curve progression will be evaluated by X-ray as in the standard of care
Number of reoperations	6 Weeks, 3 months, 6 months, 12 months, 24 months	in case the patient requires a re-operation it will be documented in the study CRF

Trial Locations

Locations (1)

Paidon Pentelis Hospital; 🇬🇷 Athens, Greece