None listed
Conditions
Brief summary
The pedicle screw system is a posterior implantable system to stabilize spinal segments and promote fusion. The pedicle screw system will be utilized to facilitate deformity correction in adolescent patients with scoliosis. The study will look at the amount of correction of the curve from x-ray images at baseline and compare those to x-ray images of the spine post-implant and at follow-up visits. The study will also evaluate the safety profile of the device and collect information on any serious device and/or procedural adverse events.
Interventions
Surgical implantation of the pedicle screw system in adolescent patients to correct curvature of the spine. The system is left in place until skeletal maturity and adequate curve correction. Depending on the maturity of the patient when implanted, will determine the length of time the system will be left in place. It is assumed most patients will have the device for 2 - 5 years. The surgical implantation procedure is just like that of the standard pedicle screw systems that are currently used
Surgical implantation of the pedicle screw system in adolescent patients to correct curvature of the spine. The system is left in place until skeletal maturity and adequate curve correction. Depending on the maturity of the patient when implanted, will determine the length of time the system will be left in place. It is assumed most patients will have the device for 2 - 5 years. The surgical implantation procedure is just like that of the standard pedicle screw systems that are currently used in surgery using a posterior approach. The system uses pedicle screws, rods and cables to align the spine. The procedure will last about 2 - 4 hours depending on the number of pedicle screws that are placed.
Sponsors
Kspine
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Subject has AIS with Lenke type 1A or 1B main thoracic curve Cobb angle between 40 and 65 degrees Curve must reduce to greater than or equal to 50 % on lateral bend x-ray Subject does not have hyper-kyphotic thoras defined as greater than or equal to 50 degree angle on lateral x-ray Sanders score 3 - 7
Exclusion criteria
hyper-kyphotic thorax (greater than or equal to 50 degrees) History of metabolic bone disease affecting bone structure Previous spine surgery Active infection Pregnant or planning to become pregnant during the study
Outcome results
None listed