Treatment of Spondylolysisin Pediatric Patients.

NCT03675152 | Unknown

• 1 other identifier: T45/2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

spondylolysis; pediatric

Outcome Measures

Primary Outcomes (1)

• Healing of spondylolysis in computed tomography

  Bony healing on 4 month CT-scan measured in three categories: healed, healing in process, not healed.

  4 months

Secondary Outcomes (13)

• developement of spondylolisthesis

  2 years

• Pain measurement 1: Oswestry disability index

  Baseline, 4 months, 12months and 24 months

• Pain measurement 2

  Baseline, 4 months, 12months and 24 months

• Pain measurement 3

  Baseline, 4 months, 12months and 24 months

• Life quality: SRS-24

  Baseline, 4 months, 12months and 24 months

Study Arms (2)

Soft spinal brace

EXPERIMENTAL

Soft spinal brace used 23 hours a day for 4 months.

Other: Soft spinal brace; Other: Excersice restriction

thoracolumbar orthosis

ACTIVE COMPARATOR

Thoracolumbar orthosis used 23 hours a day for 4 months.

Other: thoracolumbar orthosis; Other: Excersice restriction

Interventions

Soft spinal brace OTHER

Soft thoracolumbar brace worn 23 hours a day.

Soft spinal brace

thoracolumbar orthosis OTHER

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

thoracolumbar orthosis

Excersice restriction OTHER

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

Soft spinal brace; thoracolumbar orthosis

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Spondylolisthesis
• Systemic skeletal disorder (Osteogenesis imperfecta, skeletal dysplasia)
• Lack of interest

Sponsors & Collaborators

• Turku University Hospital: lead
• Satakunta Central Hospital: collaborator

Study Sites (2)

Satakunta central hospital

Pori, 28500, Finland

Location

Turku university hospital

Turku, 20500, Finland

Location

MeSH Terms

Conditions

Low Back Pain; Fractures, Stress; Spondylolysis

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ella Virkki

  pediatric surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: patients are in two groups treated with soft spinal brace or with thoracolumbar orthosis.

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: September 18, 2018
• Study Start: June 12, 2016
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)