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

NCT04912674 | Active Not Recruiting FDA Device

• 1 other identifier: 2140
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Cervical Deformity

Keywords

Cervical deformity; Kyphosis; Scoliosis

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (6)

• EAT-10

  Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

• Voice Handicap Index (VHI-10)

  Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

• Adverse events

  6 weeks, 1 year, and 2 years

• Edmonton Frail Scale

  Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

• CHSA Frail Scale

  Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

Study Arms (1)

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

Device: Symphony OCT System

Interventions

Symphony OCT System DEVICE

Surgical intervention will be patient specified by treating surgeon.

Operative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult cervical deformity patients from spine surgeon clinic

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Spine Study Group Foundation: lead
• DePuy Synthes: collaborator

Study Sites (6)

University of California Davis

Sacramento, California, 95817, United States

Location

Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center

Denver, Colorado, 80128, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Kyphosis; Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: July 12, 2021
• Primary Completion (Estimated): July 12, 2027
• Study Completion (Estimated): July 12, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)