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

NCT03519321 | Unknown

• 1 other identifier: AF-MID-C-EOS 01-16
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Early Onset Scoliosis (EOS)

Outcome Measures

Primary Outcomes (1)

• 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 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

  6 months, 12 months, 24 months

• No progression of the secondary (compensatory) curves ≥ 50 degrees Cobb angle over time at all follow-up visits

  6 months, 12 months, 24 months

• Blood loss during surgery

  Baseline - week 0

• Duration of surgery

  Baseline - week 0

• Duration of hospitalisation

  Baseline - week 0

Other Outcomes (1)

• Device related serious adverse events

  6 Weeks, 3 months, 6 months, 12 months, 24 months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: MID-C

Interventions

MID-C 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.

Treatment

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Apifix: lead

Study Sites (1)

Paidon Pentelis Hospital

Athens, Greece

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ron El-Hawary, MD

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

  STUDY DIRECTOR

• Ioanna Paspati, MD

  Spine surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphna Zaaroor Regev, PhD

CONTACT

+972-523763653; Daphna@apifix.com

Uri Arnin

CONTACT

Uri@apifix.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 8, 2018
• Study Start: April 11, 2018
• Primary Completion: June 20, 2023
• Study Completion: July 20, 2023
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)