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

Scoliosis Clinical Trial

Official title:

Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Early Onset Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03519321
• Other study ID #: AF-MID-C-EOS 01-16
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2018
• Est. completion date: July 20, 2023

Study information

• Verified date: July 2021
• Source: Apifix
• Contact: Daphna Zaaroor Regev, PhD
• Phone: +972-523763653
• Email: Daphna[@]apifix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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 = 50° 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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic
• Scoliosis;Congenital

Intervention

Device:
• MID-C
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.

Locations

Country	Name	City	State
Greece	Paidon Pentelis Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Apifix

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device related serious adverse events	AE will be monitored routinely	6 Weeks, 3 months, 6 months, 12 months, 24 months
Primary	Maintenance of the major curvature = 50 degrees at 24 months	curve progression will be evaluated by X-ray as in the standard of care	24 months
Secondary	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	6 months, 12 months, 24 months
Secondary	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	6 months, 12 months, 24 months
Secondary	Blood loss during surgery	Data will be collected from the hospital surgery records	Baseline - week 0
Secondary	Duration of surgery	Data will be collected from the hospital surgery records	Baseline - week 0
Secondary	Duration of hospitalisation	Data will be collected from the hospital records	Baseline - week 0
Secondary	Number of reoperations	in case the patient requires a re-operation it will be documented in the study CRF	6 Weeks, 3 months, 6 months, 12 months, 24 months