- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04912674
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
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jenny De Jong, MSN, RN
- Phone Number: 540-421-3101
- Email: jenny_dejong@outlook.com
Study Contact Backup
- Name: Ray Pinteric
- Email: ray.pinteric@outlook.com
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:
- Breton Line, BS
- Phone Number: 303-762-3472
- Email: breton.line@gmail.com
-
-
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:
- Alison Hageman
- Email: hageman@wustl.edu
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Not yet recruiting
- Duke University
-
Contact:
- Ronald Pegues
- Email: ronald.pegues@duke.edu
-
Principal Investigator:
- Christopher Shaffrey, MD
-
Sub-Investigator:
- Khoi Than, MD
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15219
- Recruiting
- University of Pittsburgh Medical Center
-
Contact:
- Lauren Puccio
- Email: pucciolm@upmc.edu
-
Principal Investigator:
- Thomas Buell, MD
-
Sub-Investigator:
- David Okonkwo, MD
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia
-
Contact:
- Lorrie Sipe
- Phone Number: 434-924-8775
- Email: lag3k@virginia.edu
-
Principal Investigator:
- Justin Smith, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Operative
Inclusion Criteria:
Exclusion Criteria:
|
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
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
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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