Clinical trial NCT04912674: Evaluation of Symphony™ Posterior Cervical System for 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Deformity
Keywords: Cervical deformity
Kyphosis
Scoliosis
Lead sponsor: International Spine Study Group Foundation
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2021-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cervical deformity patients from spine surgeon clinic

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Numeric rating scale (NRS) - Headaches
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Pain Numeric rating scale (NRS) - Neck
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Pain Numeric rating scale (NRS) - Upper extremity
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Pain Numeric rating scale (NRS) - Lower extremity
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Pain Numeric rating scale (NRS) - Back
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Neck Disability Index (NDI)
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (Role)
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Spine Radiographs
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Modified Japanese Orthopaedic Association Scale (mJOA)
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Secondary outcomes:
measure: EAT-10
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Voice Handicap Index (VHI-10)
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Adverse events
timeFrame: 6 weeks, 1 year, and 2 years
measure: Edmonton Frail Scale
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: CHSA Frail Scale
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
measure: Dynamometer Hand Grip Strength test
timeFrame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Denver
country: United States
facility: Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
state: Colorado
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Justin Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Christopher Shaffrey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Denver Int'l Spine Center, Rocky Mountain Hospital for Children & Presbyterian St. Luke's MC
name: Shay Bess, MD
role: PRINCIPAL_INVESTIGATOR
References: