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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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

Locations
United States
California
University of California Davis
ACTIVE_NOT_RECRUITING
Sacramento
Colorado
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
RECRUITING
Denver
Michigan
University of Michigan
WITHDRAWN
Ann Arbor
Missouri
Washington University
RECRUITING
St Louis
North Carolina
Duke University
NOT_YET_RECRUITING
Durham
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Jenny De Jong, MSN, RN
jenny_dejong@outlook.com
540-421-3101
Backup
Ray Pinteric
ray.pinteric@outlook.com
Time Frame
Start Date: 2021-07-12
Estimated Completion Date: 2027-07-12
Participants
Target number of participants: 100
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: DePuy Synthes
Leads: International Spine Study Group Foundation

This content was sourced from clinicaltrials.gov