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

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

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

Study Overview

• Status: Recruiting
• Conditions: Scoliosis; Scoliosis Idiopathic; Scoliosis;Congenital
• Intervention / Treatment: Device: MID-C

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daphna Zaaroor Regev, PhD; Phone Number: +972-523763653; Email: Daphna@apifix.com
• Study Contact Backup: Name: Uri Arnin; Email: Uri@apifix.com

Study Locations

• Greece
  • Athens, Greece
    • Recruiting
    • Paidon Pentelis Hospital
    • Contact: Ionna Paspati, MD; Phone Number: 697465770; Email: ipaspati@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; MID-C EOS implant will be implanted for the correction of the spine deformity in children found eligible for the study	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Blood loss during surgery	Data will be collected from the hospital surgery records	Baseline - week 0
Duration of surgery	Data will be collected from the hospital surgery records	Baseline - week 0
Duration of hospitalisation	Data will be collected from the hospital records	Baseline - week 0
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device related serious adverse events	AE will be monitored routinely	6 Weeks, 3 months, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Apifix
• Investigators: Study Director: Ron El-Hawary, MD, Chief of Orthopaedics. IWK Health Centre.Associate Professor, Dpt. of Surgery, Dalhousie University, Canada; Principal Investigator: Ioanna Paspati, MD, Spine surgeon

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Anticipated): June 20, 2023
• Study Completion (Anticipated): July 20, 2023

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Early Onset Scoliosis (EOS)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: AF-MID-C-EOS 01-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No