Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
This study is currently recruiting participants.
Verified October 2012 by Ellipse Technologies, Inc.
Sponsor:
Ellipse Technologies, Inc.
Information provided by (Responsible Party):
Ellipse Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01633931
First received: July 2, 2012
Last updated: February 26, 2013
Last verified: October 2012
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Purpose
The purpose of this study is to collect dat on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.
| Condition |
|---|
|
Adolescent Idiopathic Scoliosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System |
Resource links provided by NLM:
Further study details as provided by Ellipse Technologies, Inc.:
Primary Outcome Measures:
- Change in major scoliotic curve magnitude [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]Measured in degrees
- Number and Types of Adverse Events [ Time Frame: Operative through 36 months postoperative ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Radiographic evaluation coronal balance compared to baseline [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]
- Radiographic evaluation sagittal balance compared to baseline [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]
- Percent of patients indicated for surgical spine fusion [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]
- Quality of life assessment via SRS-30 questionnaire [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]
- Comparison of Rib Hump prominence [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]
- Expected vs. Actual Device Lengthening [ Time Frame: All postoperative visits where lengthening is conducted ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 10 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients diagnosed with Adolescent Idiopathic Diagnosis
Criteria
Inclusion Criteria:
- Diagnosis of Adolescent Idiopathic Scoliosis
- Failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing
- Skeletally immature (Risser Sign 0, 1, 2, or 3)
- In girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months
- Age between 10 and 15
- Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion
- Candidate for surgical implantation of spinal instrumentation
- Patient resides locally with respect to the Investigator's clinic and is willing and able to comply with the requirements of the protocol
- Must sign informed consent to permit the use of personal health data
Exclusion Criteria:
- Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic implant
- Patients who require an MRI following implantation
- Skeletally mature (Risser Sign 4 or 5; or fused tri-radiate cartilage)
- Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- History of previous surgical treatment for AIS
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633931
Contacts
| Contact: Behrooz Akbarnia, MD | (858) 678-0610 | akbarnia@ucsd.edu |
Locations
| Finland | |
| Lasten ja Nuorten Sairaala | Recruiting |
| Helsinki, Finland | |
| Contact: Helle Madisson, RN helle.madisson@hus.fi | |
| Principal Investigator: Mikko Mattila, MD | |
| Hong Kong | |
| University of Hong Kong | Recruiting |
| Hong Kong, Pokfulam, Hong Kong | |
| Principal Investigator: Kenneth MC Cheung, MD | |
| Italy | |
| Centro regionale Specializzato per la Chirurgia Vertebrale, Ospedale di Santorso/Schio, Vicenza | Recruiting |
| Schio, Italy | |
| Principal Investigator: Massimio Balsano, MD | |
Sponsors and Collaborators
Ellipse Technologies, Inc.
Investigators
| Principal Investigator: | Behrooz Akbarnia, MD | San Diego Center for Spinal Disorders |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ellipse Technologies, Inc. |
| ClinicalTrials.gov Identifier: | NCT01633931 History of Changes |
| Other Study ID Numbers: | PR0038 |
| Study First Received: | July 2, 2012 |
| Last Updated: | February 26, 2013 |
| Health Authority: | Italy: Ethics Committee Hong Kong: Ethics Committee Finland: Ethics Committee |
Additional relevant MeSH terms:
|
Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013