Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000373875
Ethics application status
Approved
Date submitted
26/03/2012
Date registered
2/04/2012
Date last updated
3/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of Adolescent Idiopathic Scoliosis Using the Ellipse MAGEC System
Scientific title
A Prospective, Multi-Center, Single Arm, Open-Label Study to evaluate the effect of the MAGEC Spinal Bracing and Distraction System on spinal curve progression in patients with Adolescent Idiopathic Scoliosis (AIS) who have failed external brace therapy.
Secondary ID [1] 280209 0
Nil
Universal Trial Number (UTN)
U1111-1129-4655
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent Idiopathic Scoliosis 286149 0
Condition category
Condition code
Musculoskeletal 286346 286346 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Ellipse MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that is surgically implanted using appropriate commercially available fixations components (i.e. pedicle screws, hooks, and/or connectors). The system includes a non-sterile hand held External Remote Controller that is used at various times after implant to non-invasively lengthen or shorten the implanted spinal rod. The implanted spinal rod is used to brace the spine during growth to minimize the progression of scoliosis. The rod includes a small internal magnet which allows the rod to be lengthened by use of the External Remote Controller. The MAGEC device is approved for commercial use in New Zealand and also is CE-marked.

The duration of the implant procedure is approximately 1.5 - 2.5 hours, depending on the surgeon's preferred construct.

The duration the device remains in place is prescribed by the physician and differs per patient. The device may remain in the patient for up to 5 years.
Intervention code [1] 284542 0
Treatment: Devices
Intervention code [2] 284602 0
Treatment: Surgery
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286808 0
Magnitude of curve progression compared to baseline (through follow up period) until skeletal maturity. This outcome is assessed via x-ray analysis of the spinal Cobb Angle.
Timepoint [1] 286808 0
Baseline and 1-Week, 3-Month, 6-Month, 9-Month, 12-Month, 18-Month, 24-Month, 30-Month, and 36-Month Postoperative Visits
Secondary outcome [1] 296707 0
Radiographic evaluation of coronal and sagittal balance compared to baseline
Timepoint [1] 296707 0
Baseline and 1-Week, 3-Month, 6-Month, 9-Month, 12-Month, 18-Month, 24-Month, 30-Month, and 36-Month Postoperative Visits
Secondary outcome [2] 296708 0
% of patients indicated for surgical spine fusion
Timepoint [2] 296708 0
36-Month Postoperatively
Secondary outcome [3] 296709 0
Quality of Life assessment via the SRS-30 Scoliosis Questionnaire
Timepoint [3] 296709 0
Baseline and 3-Month, 6-Month, 12-Month, 24-Month, and 36-Month Postoperative Visits
Secondary outcome [4] 296710 0
Comparison of Rib Hump prominence throughout follow up to baseline. This outcome is assessed via physical examination and measured with a Scoliometer.
Timepoint [4] 296710 0
Baseline and 1-Week, 3-Month, 6-Month, 9-Month, 12-Month, 18-Month, 24-Month, 30-Month, and 36-Month Postoperative Visits
Secondary outcome [5] 296711 0
Expected compared to actual device lengthening. This outcome is assessed by comparing expected lengthening values as indicated by the External Remote Controller to actual device lengthening via radiographic measurement.
Timepoint [5] 296711 0
1-Week, 3-Month, 6-Month, 9-Month, 12-Month, 18-Month, 24-Month, 30-Month, and 36-Month Postoperative Visits
Secondary outcome [6] 296712 0
Adverse Event Profile. Possible adverse events include: device malfunction, wound pain, back pain, skin problems, infection, sensitivity to metal or metal allergies, neurological deficit, construct failure, paralysis, decompensation, flat-back syndrome, bone failure, and unacceptable junctional kyphosis. Adverse events are assessed at every subject visit to the site via physical examination and radiographic evaluation.
Timepoint [6] 296712 0
Baseline and 1-Week, 3-Month, 6-Month, 9-Month, 12-Month, 18-Month, 24-Month, 30-Month, and 36-Month Postoperative Visits

Eligibility
Key inclusion criteria
Diagnosis of Adolescent Idiopathic Scoliosis; Failed external brace therapy; Skeletally immature; Age between 10 and 15; Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion.
Minimum age
10 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with pacemaker, implanted cardiac defibrillator, or any other electronic implant; Patients who require an MRI following implantation, Patients who are pregnant or nursing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The potential participants will be screened by the investigative site to determine whether or not they meet the necessary eligibility criteria. The investigator or delegate will provide and review the informed consent form for the subject to determine his or her participation. Upon signing the informed consent, the subject is considered enrolled in the trial and scheduled for the treatment surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A - nonrandomized trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4218 0
New Zealand
State/province [1] 4218 0
Country [2] 4219 0
Hong Kong
State/province [2] 4219 0
Country [3] 4220 0
Italy
State/province [3] 4220 0
Country [4] 4221 0
Finland
State/province [4] 4221 0
Country [5] 4222 0
Switzerland
State/province [5] 4222 0

Funding & Sponsors
Funding source category [1] 284961 0
Commercial sector/Industry
Name [1] 284961 0
Ellipse Technologies, Inc.
Country [1] 284961 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Ellipse Technologies, Inc.
Address
13900 Alton Parkway, Suite 123
Irvine, CA 92618
Country
United States of America
Secondary sponsor category [1] 283830 0
None
Name [1] 283830 0
Address [1] 283830 0
Country [1] 283830 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286970 0
Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)
Ethics committee address [1] 286970 0
Ethics committee country [1] 286970 0
Hong Kong
Date submitted for ethics approval [1] 286970 0
10/02/2012
Approval date [1] 286970 0
01/03/2012
Ethics approval number [1] 286970 0
UW 12-075

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33972 0
Address 33972 0
Country 33972 0
Phone 33972 0
Fax 33972 0
Email 33972 0
Contact person for public queries
Name 17219 0
Chris Hafner
Address 17219 0
13900 Alton Parkway, Suite 123
Irvine, CA 92618
Country 17219 0
United States of America
Phone 17219 0
+1 949 837 3600
Fax 17219 0
+1 949 837 3664
Email 17219 0
chafner@ellipse-tech.com
Contact person for scientific queries
Name 8147 0
Chris Hafner
Address 8147 0
13900 Alton Parkway, Suite 123
Irvine, CA 92618
Country 8147 0
United States of America
Phone 8147 0
+1 949 837 3600
Fax 8147 0
+1 949 837 3664
Email 8147 0
chafner@ellipse-tech.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.