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

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

Detailed Description
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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.

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

Conditions
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Cervical Deformity

Intervention / Treatment
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* Device: Symphony OCT System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Operative<br>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 | Device: Symphony OCT System<br>* Surgical intervention will be patient specified by treating surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Numeric rating scale (NRS) - Headaches | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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) | 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) | Computer adaptive PROs | Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up | 
| Spine Radiographs | 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) | 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 | 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) | Measures voice handicap as reported by the patient. | Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up | 
| Adverse events | Any adverse events that occur during study participation & meeting study established reporting criteria | 6 weeks, 1 year, and 2 years | 
| Edmonton Frail Scale | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical deformity, Kyphosis, Scoliosis