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

Primary Purpose

Scoliosis, Scoliosis Idiopathic, Scoliosis;Congenital

Status

Unknown status

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

MID-C

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Early Onset Scoliosis (EOS)

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Paidon Pentelis HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Maintenance of the major curvature ≤ 50 degrees at 24 months

curve progression will be evaluated by X-ray as in the standard of care

Secondary Outcome Measures

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

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

Blood loss during surgery

Data will be collected from the hospital surgery records

Duration of surgery

Data will be collected from the hospital surgery records

Duration of hospitalisation

Data will be collected from the hospital records

Number of reoperations

in case the patient requires a re-operation it will be documented in the study CRF

Full Information

NCT ID

NCT03519321

First Posted

April 25, 2018

Last Updated

July 21, 2021

Sponsor

Apifix

1. Study Identification

Unique Protocol Identification Number

NCT03519321

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 11, 2018 (Actual)

Primary Completion Date

June 20, 2023 (Anticipated)

Study Completion Date

July 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Apifix

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scoliosis, Scoliosis Idiopathic, Scoliosis;Congenital

Keywords

Early Onset Scoliosis (EOS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MID-C

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maintenance of the major curvature ≤ 50 degrees at 24 months

Description

curve progression will be evaluated by X-ray as in the standard of care

Time Frame

24 months

Secondary Outcome Measure Information:

Title

No progression of the primary curve ≥ 10 degrees Cobb angle from correction at time of surgery over time at all follow-up visits

Description

curve progression will be evaluated by X-ray as in the standard of care

Time Frame

6 months, 12 months, 24 months

Title

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

Description

curve progression will be evaluated by X-ray as in the standard of care

Time Frame

6 months, 12 months, 24 months

Title

Blood loss during surgery

Description

Data will be collected from the hospital surgery records

Time Frame

Baseline - week 0

Title

Duration of surgery

Description

Data will be collected from the hospital surgery records

Time Frame

Baseline - week 0

Title

Duration of hospitalisation

Description

Data will be collected from the hospital records

Time Frame

Baseline - week 0

Title

Number of reoperations

Description

in case the patient requires a re-operation it will be documented in the study CRF

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Device related serious adverse events

Description

AE will be monitored routinely

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daphna Zaaroor Regev, PhD

Phone

+972-523763653

Daphna@apifix.com

First Name & Middle Initial & Last Name or Official Title & Degree

Uri Arnin

Uri@apifix.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ron El-Hawary, MD

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ioanna Paspati, MD

Organizational Affiliation

Spine surgeon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Paidon Pentelis Hospital

City

Athens

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ionna Paspati, MD

Phone

697465770

ipaspati@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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