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

Description

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

Conditions

Cervical Deformity

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Study Overview

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Study Details

Study overview

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

Prospective Evaluation of Symphony™ Posterior Cervical System for Surgical Treatment of Adult Cervical Deformity: A Multi-Center Study

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

Condition
Cervical Deformity
Intervention / Treatment

-

Contacts and Locations

Sacramento

University of California Davis, Sacramento, California, United States, 95817

Denver

Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center, Denver, Colorado, United States, 80128

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

Durham

Duke University, Durham, North Carolina, United States, 27710

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15219

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. ≥18 years old at time of treatment
  • 2. 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:
  • 1. 10 degrees of overall cervical kyphosis (measured from C2-C7)
  • 2. 10 degrees of kyphosis across any 1 or 2 cervical segments
  • 3. 10 degrees of scoliosis
  • 4. C2-C7 SVA \>4cm
  • 3. Plan for surgical correction of cervical deformity in the next 6 months
  • 4. Willing to provide consent and complete study forms at baseline and follow-up intervals
  • 1. Active spine tumor or infection
  • 2. Deformity due to acute trauma
  • 3. Unwilling to provide consent or to complete study forms
  • 4. Prisoner
  • 5. Pregnant or immediate plans to get pregnant

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

International Spine Study Group Foundation,

Justin Smith, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Virginia

Christopher Shaffrey, MD, PRINCIPAL_INVESTIGATOR, Duke University

Shay Bess, MD, PRINCIPAL_INVESTIGATOR, Denver Int'l Spine Center, Rocky Mountain Hospital for Children & Presbyterian St. Luke's MC

Study Record Dates

2027-07-12