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Completed

NCT Number: NCT00273598

Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Moss Miami Spine Instrumentation System

Procedure

Universal Spine Instrumentation System

Procedure

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

  1. Physical function

  2. Deformity, based on clinical exam and spinal radiographs

  3. Clinicians' ratings of clinical photographs

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

  5. Surgeons' global satisfaction with the instrumentation system

  6. Complications of treatment (infection, loss of fixation, neurologic damage, and non-union)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • DePuy-Acromed, Inc.
  • Johnson & Johnson
  • Synthes Canada

Registry information

Official study title

Comparing the Moss Miami and Universal Spinal Instrumentation Systems for the Treatment of Adolescent Idiopathic Scoliosis

Important dates

Study start
1997
Study completion
2002
First posted
Jan 9, 2006
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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