NCT00680264

Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 402 (estimated)
• Sponsor: Setting Scoliosis Straight Foundation · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the radiographic and clinical outcomes of Scoliosis surgical and non-operative treatment in patients with Cerebral Palsy.

Detailed description

Bracing severe neuromuscular scoliotic curves rarely serves as definitive treatment, thus most progressive curves require surgical intervention in order to sustain or improve sitting (or ambulatory) abilities. Surgery is a demanding intervention for these patients, with variable functional gains. Controversy persists regarding indications for surgery, timing, and technique. Concerns about complications are paramount. Previous neuromuscular studies have been confined to a small number of surgeons with a narrow range of surgical instrumentation, technique, and correction. Very little evidence exists regarding the impact spinal surgery on the quality of life in children with scoliosis related to cerebral palsy. The instruments to measure quality of life are not specific to children with scoliosis related to cerebral palsy. There have been no comprehensive prospective studies published. This study would be the first large-scale prospective, multi-center series of spinal fusion outcomes in patients with Cerebral Palsy.

Conditions

• Cerebral Palsy
• Scoliosis

Timeline

• Start date: 2008-06-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2008-05-20
• Last updated: 2023-11-21

Locations

15 sites across 2 countries: United States, Canada