TABLE I.

Inclusion and Exclusion Criteria for Scoliosis Tether Pilot Study

Inclusion Criteria

Exclusion Criteria

1.Diagnosis of juvenile or adolescent idiopathic scoliosis 2.Age at enrollment of ≥8 and <15 yr 3.Risser stage 0 4.Bone age of ≤13 yr for females and males, as measured by hand/wrist radiograph assessment 5.Major right thoracic scoliosis with a Cobb angle of 35°-55° and Lenke-1 curve pattern 6.Thoracic kyphosis (T5-T12) <40° 7.Instrumentation to be applied no more cephalad than T4 and no more caudal than L2 (inclusive) 8.Menses <4 months 9.Physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations 10.Subject assent and parent/guardian consent obtained and documented

1.Age at enrollment of <8 or ≥15 yr 2.Bone age of >13 yr for females and males, as measured by hand/wrist radiograph assessment 3.Scoliosis curve of <35° or >55° 4.Thoracic kyphosis (T5-T12) ≥40° 5.Vertebrae <13 mm in height (cutoff based on the staple size) 6.Congenital scoliosis 7.Nonambulatory 8.Osteoporosis by clinical diagnosis 9.Prior ipsilateral thoracic surgery 10.Left thoracic scoliosis 11.Associated syndromes of intraspinal pathology that require neurosurgical intervention 12.Prior surgical spinal treatment in the region of planned instrumentation 13.Prior surgical procedure in the chest cavity on the side of scoliosis 14.No tolerance to 1-lung anesthesia 15.Infection in the disc or spine, past or present 16.Evidence of active infection at the time of surgery 17.Known allergy to polyethylene or titanium alloy (including the component elements of the alloy), the materials used in the device