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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00273598
Other study ID # 0019970040
Secondary ID
Status Completed
Phase Phase 2
First received January 4, 2006
Last updated October 11, 2017
Start date September 1997
Est. completion date September 2002

Study information

Verified date October 2017
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date September 2002
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 8 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Moss Miami Spine Instrumentation System

Universal Spine Instrumentation System


Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (5)

Lead Sponsor Collaborator
The Hospital for Sick Children Canadian Institutes of Health Research (CIHR), DePuy-Acromed, Inc., Johnson & Johnson, Synthes Canada

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary - Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders
Secondary Physical function
Secondary Deformity, based on clinical exam and spinal radiographs
Secondary Clinicians' ratings of clinical photographs
Secondary Surgical outcomes, as measured by blood transfusions, duration of surgery,and length of hospitalization
Secondary Surgeons' global satisfaction with the instrumentation system
Secondary Complications of treatment (infection, loss of fixation, neurologic damage, and non-union)
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