Clinical trial NCT01716936: A Retrospective Review of Early Onset Spinal Deformity Patients Treated With the Ellipse MAGEC System
Official title: A Retrospective Multicenter Review of Early Onset Spinal Deformity Patients That Underwent Either a Primary or Revision Spinal Bracing Procedure With the Ellipse Technologies MAGEC Spinal Bracing and Distraction System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Insufficiency Syndrome
Keywords: Thoracic Insufficiency Syndrome
Early Onset Spinal Deformity
Lead sponsor: Ellipse Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-30
Enrollment: 54
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients worldwide implanted with the Ellipse Technologies Spinal Bracing and Distraction System (Invitation to Volunteer Non-Probability Sample).

Brief summary: The purpose of this study is to determine the safety profile and probable benefit of the Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity associated with thoracic insufficiency syndrome.


Eligibility criteria: Inclusion Criteria:

* Early onset spinal deformity with any etiology
* Cobb angle measurement of 30 degrees or greater at the time of primary surgery
* Thoracic spine height (T1 to T12) less than 22 cm at the time of primary surgery
* Age less than 11 years old at the time of MAGEC implant
* Implanted with the MAGEC system as either a primary or secondary revision spinal bracing procedure
* Patient has been implanted for a minimum of 6 months
* Patient signs informed consent for the use of their personal private data

Exclusion Criteria:

* Patient declines to sign informed consent for the use of their personal private data.

Primary outcomes:
measure: Change in Cobb Angle
timeFrame: Baseline and 6, 12, 18 and 24 Months Postoperatively
measure: Change in Thoracic Spine Height
timeFrame: Baseline and 6, 12, 18 and 24 Months Postoperatively
measure: Change in Space Available for Lung
timeFrame: Baseline and 6, 12, 18 and 24 Months Postoperatively
measure: Ocurrence of Procedure-Related Complications
timeFrame: Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively
measure: Occurrence of Adverse Events
timeFrame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Secondary outcomes:
measure: Change in Coronal Balance
timeFrame: Baseline and 6, 12, 18 and 24 Months Postoperatively
measure: Change in Sagittal Balance
timeFrame: Baseline and 6, 12, 18 and 24 Months Postoperatively
measure: Occurrence of Subsequent surgical interventions following initial implantation
timeFrame: Baseline and 6, 12, 18 and 24 Months Postoperatively
measure: Change in Weight
timeFrame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: University of Cairo Public Hospital
city: Helsinki
country: Finland
facility: University of Helsinki
city: Turku
country: Finland
facility: Turku University Hospital
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
city: Bologna
country: Italy
facility: Instituto Rizzoli
city: Rome
country: Italy
facility: Bambin Gesu
city: Auckland
country: New Zealand
facility: Starship Children's Hospital
city: Ankara
country: Turkey
facility: Ankara Gazi Universitesi Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe University Hospital
city: Istanbul
country: Turkey
facility: Florence Nightingale Hospital Ortopedi Bolumu
city: Istanbul
country: Turkey
facility: Marmara Üniversitesi Eğt.ve Arş.Hastanesi
city: Izmir
country: Turkey
facility: Ege Sağlık Hastanesi
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital NHS Trust
state: Middlesex
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: London
country: United Kingdom
facility: The Harley Street Clinic
Study officials:
affiliation: San Diego Center for Spinal Disorders
name: Behrooz A Akbarnia, MD
role: PRINCIPAL_INVESTIGATOR
References: