Evaluation of Symphony™ Posterior Cervical System for Surgical Treatment of Adult Cervical Deformity

Running, not enrolling

Conditions studied: Cervical Deformity

In brief

Multi-center, prospective, non-randomized study to evaluate Symphony™ Posterior Cervical System in the setting of surgical treatment of adult cervical deformity.

Key facts

Study ID

NCT04912674

Run by

International Spine Study Group Foundation

People needed

100

Starts

2021-07-12

Expected to finish

2027-07-12

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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:
• Loss of cervical lordosis (≤ 0° cervical lordosis C2-7)
• ≥ 5° of kyphosis across any 1 or 2 cervical segments
• ≥ 10° of cervical scoliosis
• C2-C7 SVA ≥ 4cm
• T1 Slope minus Cervical Lordosis ≥ 20°
• Grade I or greater Spondylolisthesis at any segment C1-T1
• Horizontal Gaze ≤ 0 or ≥ 11
• 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

You may not qualify if…

• 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

Where it is running

• University of California Davis — Sacramento, California, United States
• Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center — Denver, Colorado, United States
• Washington University — St Louis, Missouri, United States
• Duke University — Durham, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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