Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

NCT00273598 | Completed Phase 2

• 1 other identifier: 0019970040
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic scoliosis affects 2-5% of adolescents. This study will compare the quality of life, functional outcome, cosmetic result, and the correction of spinal deformity of two instrumentation systems for the treatment of adolescent idiopathic scoliosis.

Conditions

Scoliosis

Keywords

Scoliosis; spinal disease; pediatrics; Adolescents; Universal Spinal Instrumentation System; Moss Miami Spinal Instrumentation System; Orthopedic Surgery

Outcome Measures

Primary Outcomes (1)

• - Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders

Secondary Outcomes (6)

• Physical function

• Deformity, based on clinical exam and spinal radiographs

• Clinicians' ratings of clinical photographs

• Surgical outcomes, as measured by blood transfusions, duration of surgery,and length of hospitalization

• Surgeons' global satisfaction with the instrumentation system

Interventions

Moss Miami Spine Instrumentation System PROCEDURE

Universal Spine Instrumentation System PROCEDURE

Eligibility Criteria

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

You may qualify if:

• Age 8-18 years
• Diagnosis of idiopathic scoliosis requiring posterior instrumentation and fusion(including those also requiring anterior release with or without anterior instrumentation) who could receive either the USS or the Moss Miami system
• Patients with scoliosis and an incidental finding of conus \< L1-2 disc level, provided they have no symptoms or signs
• Patients with scoliosis and an incidental finding of a small syrinx (provided the syrinx is non-progressive and does not require neurosurgical treatment)
• Patients with non-progressive spondylolysis

You may not qualify if:

• Spinal cord abnormalities with any neurologic symptoms or signs
• Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
• Primary muscle diseases, such as muscular dystrophy
• Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, etc.)
• Primary abnormalities of bones(e.g. osteogenesis imperfecta)
• Congenital scoliosis

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Synthes Canada: collaborator
• DePuy-Acromed, Inc.: collaborator
• Johnson & Johnson: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Wright JG, Donaldson S, Howard A, Stephens D, Alman B, Hedden D. Are surgeons' preferences for instrumentation related to patient outcomes? A randomized clinical trial of two implants for idiopathic scoliosis. J Bone Joint Surg Am. 2007 Dec;89(12):2684-93. doi: 10.2106/JBJS.F.00720.

  PMID: 18056501 BACKGROUND

MeSH Terms

Conditions

Scoliosis; Spinal Diseases

Condition Hierarchy (Ancestors)

Spinal Curvatures; Bone Diseases; Musculoskeletal Diseases

Study Officials

• James G Wright, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon-in-Chief & Chief of Perioperative Services

Study Record Dates

• First Submitted: January 4, 2006
• First Posted: January 9, 2006
• Study Start: September 1, 1997
• Study Completion: September 1, 2002
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

CA (1)