Treatment of Spondylolysisin Pediatric Patients.
Treatment of Spondylolysisin Pediatric Patients.
A clinical trial comparing healing of unilateral or bilateral spondylolysis in children
 treated with a Boston thoracolumbar orthosis (brace) or with a soft spinal brace (Porostrap
 lumbar support) for four months. Inclusion criteria will be a child or adolescent aged
 between 8 and 20 years with an early uni- or bilateral defect (fracture line) in the pars
 interarticularis in the CT-scan with no signs of bony sclerosis. Additionally, bone marrow
 edema has to be confirmed in MR images (T2 sagittal) as a sign of an early lesion. Exclusion
 criteria will be spondylolisthesis on standing spinal radiograph, systemic skeletal disorder
 or lack of interest. Patient's preference defines the treatment method. Minimum follow-up
 time will be 2 years for all patients. According to statistical power analysis a total of 60
 patients will be needed to provide evidence for the effectiveness or no effectiveness of
 rigid thoracolumbar orthosis on the natural history of early spondylolysis. Measured outcome
 parameters are 1) Bony healing on CT-scan, 2) SRS-24-score at the beginning of the treatment
 and during the 2-year follow-up, 3) Back and lower extremity pain at the beginning of the
 treatment and during the 2-year follow-up (Pain drawing including VAS-score in children under
 16 years old, Oswestry disability index including VAS-score in patients over 16 years old),
 4) Thoracolumbar radiographs at 2-year follow-up: Evidence of spondylolisthesis, 5) Trunk
 strength and spinal mobility at follow-up visits.

 As part of this study, the investigators will also evaluate patients with spondylolysis
 treated in their hospitals before this clinical trial begun. In this retrospective study they
 will evaluate all patients between 8 and 20 years of age with spondylolysis, which have been
 treated with thoracolumbar orthosis after year 2009 and are not participating in to
 prospective study. Main focus will be in bony healing in CT-scans after brace treatment.
A clinical trial comparing effectiveness of a soft spinal brace and a rigid thoracolumbar
 orthosis will be performed. Patients will choose the treatment method (patient preference).
 One option is to be treated, as what is known as a golden standard, with a hard thoracolumbar
 brace (Boston brace) worn daily for four months. The other option is to be treated with a
 soft spinal brace for four months. The soft brace we use in this study is DJO Global's
 Porostrap lumbar support. Both groups cease from sporting activities and get identical
 physiotherapy, where the aim is to strengthen abdominal and back muscles. After four month
 brace treatment we will have a control appointment where a CT-scan is taken to detect the
 bony healing of the pars interarticularis. Other follow-up appointments will be at 12 months
 and 24 months. Subjective healing is measured each time with SRS-24-score and Oswestry
 disability Index or pain drawing. During the last appointment, approximately 2 years after
 beginning of the study, a standing lateral thoracolumbar radiograph is taken to detect if the
 patient has developed spondylolisthesis. Trunk strength and spinal mobility is measured at
 follow-up visits (4 months, 12months, and 24months).

 SRS-24 questionnaire is a translated and modified version of the Scoliosis Research
 Society-22 questionnaire. The two first questions measure the intensity of the pain (1
 meaning no pain and 9 referring to the worst pain imagined). The remaining 22 questions have
 five alternatives from 1 (the worst option) to 5 (the best option) and they intend to measure
 the health-related quality of life. It has been well validated and proved reliable in
 investigating children with scoliosis quality of life (18).

 Oswestry disability Index (ODI) is an index used to evaluate patients' back and lower
 extremity pain translated in Finnish or Swedish (19). It consists of ten questions and
 VAS-score. One question is about sexual life and that's why this questionnaire is used only
 for patients over 16 years old. Patients under 16 years old are asked to fill a pain drawing.
 This also includes VAS-score.

 Visual analogue score (VAS) is a numeric pain distress scale from 0 to 10, where zero refers
 to "no pain" and ten to " unbearable pain". Patient draws his/her pain in a line from 0 to
 10. During each appointment a patient is asked to describe their back pain and/or lower
 extremity pain in this scale as it is included in both pain drawing and ODI.

 Trunk strength and spinal mobility tests are used to evaluate the effect of the use of the
 brace to the muscles and movement of the trunk. The centimeters with a tape measure from the
 fingertips on the thigh in side-bend are measured and we grade it abnormal, if the
 measurement is over 2 standard deviations under the mean of the Finnish reference values
 (20). Non-dynamometric trunk performance is measured with repetitive sit-up, arch-up and
 squatting tests. The result is graded from 1 (poor) to 5 (excellent). 1 refers to 1 standard
 deviation or more below the mean of the normal Finnish population values and 5 to 1 standard
 deviation or more above this mean (21).

 In MRI, from the T2 spin-echo weighted images disc degeneration is graded based on Pfirrmann
 classification. Grade I refers to normal disc and grade V to most advanced disc degeneration.
 (22).

 Computed tomography (CT) is widely used to diagnose spondylolysis and to detect healing of
 it. It shows bony healing and nonunion (12). A standing lateral thoracolumbar radiograph is
 taken at last follow-up visit to determine spondylolisthesis. This is understood as an
 indirect sign of failure of the treatment of the spondylolysis.
Inclusion Criteria:

 -  Early uni- or bilateral defect in pars interarticularis in the CT-scan

 -  No signs of bony sclerosis on CT

 -  No signs of spondylolisthesis on standing lumbar radiographs

 -  Bone marrow edema in lumbar spinal MR images

 -  Age between 8 and 20 years

 -  Written informed consent

 Exclusion Criteria:

 -  Spondylolisthesis

 -  Systemic skeletal disorder (Osteogenesis imperfecta, skeletal dysplasia)

 -  Lack of interest