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

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 2 year follow up. Outcome metrics will include standardized patient reported outcome measures, radiographic analysis of deformity correction and spinal alignment.
  • Evaluate rates and risk factors for perioperative complications and need for revision surgery at 6 weeks, 1 year, and 2 years postoperatively.
  • Develop and validate a surgical invasiveness index for cervical deformity surgical procedures
  • Validate the cervical deformity frailty index previously developed by the ISSG and further optimize this index
  • Establish adult cervical deformity specific thresholds for minimal clinically important difference (MCID) for standard outcomes measures using a patient satisfaction anchor
  • Develop a series of predictive models for adult cervical deformity surgery, including outcomes (e.g. overall change and achievement of MCID), occurrence of complications, and radiographic changes
  • Assess the psychological impact of adult cervical deformity, how psychological measures change following surgical treatment, and whether there are correlations between baseline psychological factors and outcomes following surgery
  • Assess baseline functional measures (e.g. grip strength) for adult cervical deformity patients presenting for surgery, assess how these functional measures change following surgery, and assess whether there are correlations between baseline functional measures and likelihood to improve following surgery
  • Assess baseline narcotic use among adult cervical deformity patients presenting for surgery
  • Assess changes in narcotic use from baseline to follow-up intervals after surgical treatment for adult cervical deformity
  • Assess for correlations between narcotic use (baseline and follow-up) and outcomes following surgical treatment for adult cervical deformity
  • Assess the impact of osteopenia and osteoporosis on patient frailty, complications, and maintenance of deformity correction
  • Define clinical and demographic features of the population afflicted with cervical deformity (e.g., age, gender, comorbidities, disability, health-related quality of life)
  • Assess for correlations between radiographic parameters and degree of disability/pain at baseline
  • Assess and describe surgical strategies used to address cervical deformity
  • Define complications and rates of complications (perioperative and delayed) associated with the surgical treatment of cervical deformity
  • Assess the role/need for pre/post operative tracheostomy and PEG
  • Evaluate and compare radiographic changes of sagittal spinal alignment (focal, regional, and global) and pelvic parameters pre and post cervical deformity surgery.
  • Develop predictive formulas of post-operative alignments based on surgical techniques employed for correction
  • Identify risk factors related to poor clinical outcomes
  • Define potential impact of complications on clinical/radiographic outcomes
  • Determine reoperation rates over two-year follow-up period
  • Assess change in subaxial alignment after occiput to C2 fusion
  • Assess the effect of C1-2 lordosis and C1-2 fusion on subaxial alignment and outcome
  • Assess outcomes of long fusions involving the occiput related to head center of gravity and regional and global balance
  • Assess outcomes of occipital-cervical-thoracic fusion on cervical alignment and global alignment
  • Evaluate clinical outcomes (short- and long-term) following cervical deformity surgery
  • Assess cost-effectiveness of adult cervical deformity surgery
  • Correlate different measures of frailty, including Edmonton, CHSA, and ISSG.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • Sacramento, California, United States, 95817
        • Active, not recruiting
        • University of California Davis
    • Colorado
      • Denver, Colorado, United States, 80128
        • Recruiting
        • Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
        • Principal Investigator:
          • Shay Bess, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Withdrawn
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Principal Investigator:
          • Munish Gupta, MD
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Not yet recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Christopher Shaffrey, MD
        • Sub-Investigator:
          • Khoi Than, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas Buell, MD
        • Sub-Investigator:
          • David Okonkwo, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • Justin Smith, MD, PhD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult cervical deformity patients from spine surgeon clinic

Description

Inclusion 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

Exclusion Criteria:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Operative

Inclusion 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. Loss of cervical lordosis (≤ 0° cervical lordosis C2-7)
    2. ≥ 5° of kyphosis across any 1 or 2 cervical segments
    3. ≥ 10° of cervical scoliosis
    4. C2-C7 SVA ≥ 4cm
    5. T1 Slope minus Cervical Lordosis ≥ 20°
    6. Grade I or greater Spondylolisthesis at any segment C1-T1
    7. Horizontal Gaze ≤ 0 or ≥ 11
  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

Exclusion Criteria:

  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
Surgical intervention will be patient specified by treating surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Numeric rating scale (NRS) - Headaches
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Self reported pain in Head where 0=no pain/10=severe pain
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Pain Numeric rating scale (NRS) - Neck
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Self-reported pain in Neck where 0=no pain/10=severe pain
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Pain Numeric rating scale (NRS) - Upper extremity
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Self-reported pain in Arms where 0=no pain/10=severe pain
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Pain Numeric rating scale (NRS) - Lower extremity
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Self-reported pain in Legs where 0=no pain/10=severe pain
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Pain Numeric rating scale (NRS) - Back
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Self-reported pain in Back where 0=no pain/10=severe pain
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Neck Disability Index (NDI)
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient reported neck disability tool
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Veterans RAND 12 Item Health Survey (VR-12)
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient reported outcome
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (Role)
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Spine Radiographs
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Radiographic parameters (Cervical lordosis, Kyphosis, Scoliosis; Global balance in coronal and sagittal planes of the spine; pelvic parameters (pelvic incidence, tilt, slope) and bony fusion status
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Modified Japanese Orthopaedic Association Scale (mJOA)
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient reported outcome measuring functional status using scale of 0 to 18. The higher the score, the less disability.
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EAT-10
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Measures swallowing difficulties as reported by the patient.
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Voice Handicap Index (VHI-10)
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Measures voice handicap as reported by the patient.
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Adverse events
Time Frame: 6 weeks, 1 year, and 2 years
Any adverse events that occur during study participation & meeting study established reporting criteria
6 weeks, 1 year, and 2 years
Edmonton Frail Scale
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Frailty scale from 0 to 17 where the higher the score the more frail the patient
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
CHSA Frail Scale
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Clinical Frailty Scale from 1 to 9 where the higher the score, the more frail the patient
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Dynamometer Hand Grip Strength test
Time Frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
With patient seated, patient will squeeze the dynamometer as hard as he/she can with each hand.
Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Justin Smith, MD, PhD, University of Virginia
  • Principal Investigator: Christopher Shaffrey, MD, Duke University
  • Principal Investigator: Shay Bess, MD, 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 Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Estimated)

July 12, 2027

Study Completion (Estimated)

July 12, 2027

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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