Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273598
• Other study ID #: 0019970040
• 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
• 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
• 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

Related Conditions & MeSH terms

• Scoliosis

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)