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

Cervical Deformity Clinical Trial

— Symphony  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04912674
• Other study ID #: 2140
• Status: Recruiting
• Start date: July 12, 2021
• Est. completion date: July 12, 2027

Study information

• Verified date: March 2024
• Source: International Spine Study Group Foundation
• Contact: Jenny De Jong, MSN, RN
• Phone: 540-421-3101
• Email: jenny_dejong[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 12, 2027
• Est. primary completion date: July 12, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Deformity
• Congenital Abnormalities

Intervention

Device:
• Symphony OCT System
Surgical intervention will be patient specified by treating surgeon.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Virginia	Charlottesville	Virginia
United States	Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of California Davis	Sacramento	California
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
International Spine Study Group Foundation	DePuy Synthes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Neck Disability Index (NDI)	Patient reported neck disability tool	Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	EAT-10	Measures swallowing difficulties as reported by the patient.	Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Secondary	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
Secondary	Adverse events	Any adverse events that occur during study participation & meeting study established reporting criteria	6 weeks, 1 year, and 2 years
Secondary	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
Secondary	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
Secondary	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