Status:
RECRUITING
Evaluation of Symphony™ Posterior Cervical System for Surgical Treatment of Adult Cervical Deformity
Lead Sponsor:
International Spine Study Group Foundation
Collaborating Sponsors:
DePuy Synthes
Conditions:
Cervical Deformity
Eligibility:
All Genders
18+ years
Brief Summary
Multi-center, prospective, non-randomized study to evaluate Symphony™ Posterior Cervical System in the setting of surgical treatment of adult cervical deformity.
Detailed Description
Specific Aims: * Evaluate outcomes for operative treatment of adult cervical deformity patients treated with posterior spinal fusion using SymphonyTM posterior cervical system at 6 weeks, 1 year, and...
Eligibility Criteria
Inclusion
- ≥18 years old at time of treatment
- Patient undergoing a posterior cervical instrumented fusion using the DePuy Synthes SymphonyTM OCT System for the treatment of adult cervical deformity, defined as any of below criteria:
- 10 degrees of overall cervical kyphosis (measured from C2-C7)
- 10 degrees of kyphosis across any 1 or 2 cervical segments
- 10 degrees of scoliosis
- C2-C7 SVA \>4cm
- Plan for surgical correction of cervical deformity in the next 6 months
- Willing to provide consent and complete study forms at baseline and follow-up intervals
Exclusion
- Active spine tumor or infection
- Deformity due to acute trauma
- Unwilling to provide consent or to complete study forms
- Prisoner
- Pregnant or immediate plans to get pregnant
Key Trial Info
Start Date :
July 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 12 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04912674
Start Date
July 12 2021
End Date
July 12 2027
Last Update
March 6 2024
Active Locations (7)
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1
University of California Davis
Sacramento, California, United States, 95817
2
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Colorado, United States, 80128
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Washington University
St Louis, Missouri, United States, 63110