Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity
Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity
This study was sponsored by Federal state budgetary institution "Russian scientific center
 for traumatology and orthopedics" n.a. acad. G.A. Ilizarov" of the Ministry of Health of
 Russian Federation. The study will take place at this center.

 It is expected to enroll 70 patients aged 10-18 years with NMD, all of whom will be subjected
 to thoracic and lumbar spinal deformity surgery.

 Patients will be divided into two groups depending on skeletal maturity. The degree of
 skeletal maturity will be determined on the basis of an X-ray study of spinal and pelvic
 bones. The type of surgical correction will depend on the group.
First group of patients: local dorsal access. Cranial access: at the level of posterior Th2 5
 structures and caudally at the level of L4-S2 vertebrae with exposure of posterior upper
 spines of iliac wings. Skeletization of vertebrae will be done within transverse processes.
 Pedicle support points are set bilaterally cranially at each segment level for the space of 3
 segments. Caudal support base is formed with pedicle screws in lateral masses of the sacral
 bone or iliac crests at the level of L5-S1 vertebrae. Control fluorography is performed in
 two standard planes in order to control screw position. Two "dynamic" rods are formed on the
 basis of the distance between screw heads allowing 2 cm for distraction; these are two rods
 connected with a longitudinal connector and bent following the normal sagittal spine profile.
 After that, channels are formed on both sides under m. erector spinae in the cranial/caudal
 direction. Pre-bent rods with connectors are placed into the prepared channels. The metal
 construct is stabilized with internal set screws. If necessary, the construct may be
 stiffened with crosslinks. Control fluorography is performed in two standard planes in order
 to control implant position and evaluate correction. The intervention completes with local
 dorsal spinal fusion with an autobone at the level of base screws. The wound is sewn up in
 layers tightly.

 Group two: dorsal access to the posterior column is gained in accordance with the
 preoperative plan. The access length depends on the instrumentation area. Vertebral
 skeletization is performed within transverse processes. Subgroup 1 - pedicle support points
 are set bilaterally at each segment level. Subgroup 2 - pedicle support points are set
 bilaterally in every second segment. Segmented instrumentation of 3 cranial segments to
 prevent dislocation of metal construct elements at the level of Th2-4 or Th3-5 vertebrae is a
 special measure. Similar to group I, caudal support base is formed with pedicle screws in
 lateral masses of the sacral bone or iliac crests at the level of L5-S1 vertebrae. Control
 fluorography is performed after that in two standard planes in order to control screw
 position. Segmented facetectomy is recommended for additional spine mobilization. Pre-bent
 rods are placed into support points. Deformity correction is performed by means of a
 translational maneuver, segmented distraction (concave side) and compression (convex side).
 The metal construct is stabilized with internal set screws. If necessary, the construct may
 be stiffened with crosslinks. Control fluorography is performed in two standard planes in
 order to control implant position and evaluate correction. The intervention completes with
 dorsal spinal fusion with an autobone along the implants. The postoperative bed is subjected
 to Redon drain. The drainage is exteriorized to the skin via a separate puncture. The wound
 is sewn up in layers tightly.
Inclusion Criteria:

 -  Signed and dated informed consent for participation in the study (separate informed
 consents for child and parents/caregivers), obtained before conducting any study
 procedures

 -  Verified and documented diagnosis (neuromuscular desease, NMD) with the results of
 neurologic examination

 -  Deformity of thoracic and/or lumbar spine associated with NMD, which requires surgical
 intervention

 Exclusion Criteria:

 -  Patient unwillingness or inability to follow study procedures

 -  Absence of signed and dated informed consent for participation in the study (as for
 child and for parents/caregivers)

 -  Patient participation in another clinical study, which can influence the results of
 this study

 -  Left ventricle ejection fraction less than 40% by echocardiography

 -  FEV >20

 -  Life expectancy <12 months

 -  Liver insufficiency: ALT, AST and total bilirubin twice higher than normal

 -  Kidney insufficiency (creatinine clearance <60 ml/min)

 -  Concomitant diseases, which preclude patient participation in this study according to
 doctor's opinion