Scoliosis Clinical Trial
Official title:
A Prospective Cohort Study of the Surgical Treatment of Early Onset Scoliosis Using a Remotely Expandable Device for Non-invasive Lengthening of a Growing Rod (Magec™) and Its Performance in Prevention of Progression of Scoliosis.
It is current practice for children who have surgery for early onset scoliosis (EOS) to be
treated with insertion of extendable implants known as growth rod systems. This allows the
growth potential of the child to be maximised during the period of growth. However, the child
must undergo an average of 6 further surgeries to lengthen the rods every 6 months. Sometimes
this may continue for several years. This requires repeated general anaesthesia and places
the patient at risk of complications as well as on-going costs to the hospital with each
admission and theatre episode.
Magec is a magnetic growth rod from Ellipse technologies (distributed by SurgiC). The rod is
inserted in exactly the same way as the conventional growth rod systems. The base implants
i.e screws and hooks remain the preferred choice of the user. The only change is that a
different rod is used.
There are several advantages to this device. Firstly, after the initial insertion, further
lengthenings, unlike current systems, do not need to be carried out in theatre under a
general anaesthetic. In contrast, they can be done in an outpatients setting with a
non-invasive technique. The rods are lengthened using an external magnetic device. The
lengthenings are done in a controlled manner using an age related growth guide. Thirdly, the
change from a theatre based intervention to an outpatient procedure will have cost-savings.
The investigators also believe that there will be psychosocial benefits to the child and
family by the avoiding the stress associated with repeated surgery at such a young age.
In terms of risk assessment the device does not place the child at any more risk than would
be expected from inserting any of the existing systems. In the event of failure of the rods
the worst outcome is a revision to conventional rods.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
| Recruiting |
NCT05944393 -
Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
|
N/A | |
| Recruiting |
NCT05888038 -
Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
|
N/A | |
| Completed |
NCT02558985 -
Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
|
||
| Completed |
NCT02413788 -
Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
|
N/A | |
| Completed |
NCT02890654 -
Scoliosis and Quality of Life of Adolescents
|
||
| Completed |
NCT02531945 -
Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years
|
N/A | |
| Completed |
NCT02609009 -
Back Pain and Spinal Manipulation in Adolescent Scoliosis
|
N/A | |
| Terminated |
NCT02134704 -
MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
|
N/A | |
| Completed |
NCT02285621 -
Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
|
N/A | |
| Withdrawn |
NCT00768313 -
Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.
|
Phase 4 | |
| Completed |
NCT00155545 -
Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients
|
Phase 1 | |
| Completed |
NCT00154505 -
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
|
Phase 1 | |
| Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
| Completed |
NCT00273598 -
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
|
Phase 2 | |
| Completed |
NCT03135665 -
Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure
|
N/A | |
| Completed |
NCT06428864 -
Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
|
||
| Recruiting |
NCT04423146 -
Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery
|
||
| Completed |
NCT03814239 -
Blood and Fluid Management During Scoliosis Surgery
|
||
| Withdrawn |
NCT02058238 -
ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
|