RECRUITING

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

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Conditions

Cervical DeformityKyphosisScoliosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-07-12
Study Completion:2027-07-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04912674

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥18 years old at time of treatment
  2. 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:
  3. 1. 10 degrees of overall cervical kyphosis (measured from C2-C7)
  4. 2. 10 degrees of kyphosis across any 1 or 2 cervical segments
  5. 3. 10 degrees of scoliosis
  6. 4. C2-C7 SVA \>4cm
  7. 3. Plan for surgical correction of cervical deformity in the next 6 months
  8. 4. Willing to provide consent and complete study forms at baseline and follow-up intervals
  1. 1. Active spine tumor or infection
  2. 2. Deformity due to acute trauma
  3. 3. Unwilling to provide consent or to complete study forms
  4. 4. Prisoner
  5. 5. Pregnant or immediate plans to get pregnant

Contacts and Locations

Study Contact

Jenny De Jong, MSN, RN
CONTACT
540-421-3101
jenny_dejong@outlook.com
Ray Pinteric
CONTACT
ray.pinteric@outlook.com

Principal Investigator

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 Locations (Sites)

University of California Davis
Sacramento, California, 95817
United States
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Colorado, 80128
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Washington University
Saint Louis, Missouri, 63110
United States
Duke University
Durham, North Carolina, 27710
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-12
Study Completion Date2027-07-12

Study Record Updates

Study Start Date2021-07-12
Study Completion Date2027-07-12

Terms related to this study

Keywords Provided by Researchers

  • Cervical deformity
  • Kyphosis
  • Scoliosis

Additional Relevant MeSH Terms

  • Cervical Deformity