Treatment of Spondylolysisin Pediatric Patients.

Summary

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.

Conditions

• Low Back Pain
• Stress Fracture

Interventions

OTHER

Soft spinal brace

Soft thoracolumbar brace worn 23 hours a day.

OTHER

thoracolumbar orthosis

Hard thoracolumbar orthosis done individually molded, Worn 23 hours a day.

OTHER

Excersice restriction

Patients are only allowed to do isometrical excersices adviced by a physiotherapist.

Sponsors & Collaborators

• Satakunta Central Hospital

  collaborator OTHER

• Turku University Hospital

  lead OTHER_GOV

Principal Investigators

• Ella Virkki · pediatric surgeon

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-12

Primary Completion

2022-01-30

Completion

2024-01-30

Countries

• Finland

Study Locations