Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis

Shriners Hospitals for Children

Status and phase: Completed; Phase 4

Conditions: Scoliosis

Treatments: Device: Spinal rod

Study type: Interventional

Funder types: Other

Identifiers

NCT00510575

SHCLA-0123

Details and patient eligibility

About

There are two rod sizes routinely used for the correction of juvenile and adolescent idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. Currently there is no scientific evidence supporting the superiority of one size rod relative to the other. This study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm spinal instrumentation rods.

Full description

For the correction of Juvenile and Adolescent idiopathic scoliosis, companies offer and surgeons use varying rod sizes not based on scientific evidence, but because of personal preference, availability and company loyalty. To date there has been no literature evaluating the benefit or harm of one rod size versus the other. Our dual-arm prospective study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm stainless steel instrumentation rods. These are both standard rods used in the community for this particular procedure, thus no additional risk exists for the patient. The results of this study will help guide surgeons in their decision making process when faced with the multitude of options offered by implant manufactures.

Comparison(s): 5.5mm stainless steel spinal rod versus 6.35mm stainless steel spinal rod for correction of juvenile and idiopathic scoliosis curves.

Enrollment: 300 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Juvenile or Adolescent Idiopathic Scoliosis
• Anticipated spinal fusion surgery

Exclusion criteria

• Individuals younger than 11 years and older than 18 years
• Individuals with scoliosis carrying additional diagnoses of illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

1

Active Comparator group

Description:

Subjects in this arm will receive the 5.5mm stainless steel instrumentation rod.

Treatment:

Device: Spinal rod

2

Active Comparator group

Description:

Subjects in this arm will receive a 6.35mm stainless steel instrumentation rod.

Treatment:

Device: Spinal rod