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

NCT ID: NCT03519321

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-11
• Study Completion Date: 2023-07-20

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

Conditions

Scoliosis; Scoliosis Idiopathic; Scoliosis;Congenital

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

MID-C

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apifix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron El-Hawary, MD

Role: STUDY_DIRECTOR

Chief of Orthopaedics. IWK Health Centre.Associate Professor, Dpt. of Surgery, Dalhousie University, Canada

Ioanna Paspati, MD

Role: PRINCIPAL_INVESTIGATOR

Spine surgeon

Locations

Paidon Pentelis Hospital

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Daphna Zaaroor Regev, PhD

Role: CONTACT

Daphna@apifix.com

+972-523763653

Uri Arnin

Role: CONTACT

Uri@apifix.com

Facility Contacts

Ionna Paspati, MD

Role: primary

ipaspati@yahoo.com

697465770

Other Identifiers

AF-MID-C-EOS 01-16

Identifier Type: -

Identifier Source: org_study_id