Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.

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

• ≥18 years old at time of treatment

• Diagnosis of cervical deformity- must meet one or more of the following criteria:

‣ C2-C7 sagittal kyphosis (Cobb \> 15 degrees)

⁃ T1S-CL \> 35o

⁃ Segmental cervical kyphosis \> 10 degrees between any 2 vertebra between C2-T1 or \> 15 degrees across any 3 vertebra between C2-T1

⁃ Cervical scoliosis \> 10 degrees (Cobb angle must include end vertebra within the cervical spine)

⁃ C2-C7 SVA \> 4cm

⁃ McGregor's slope \> 20 degrees or CBVA \> 25 degrees

• 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
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
RECRUITING
La Jolla
University of California Davis, Department of Orthopedic Surgery
ACTIVE_NOT_RECRUITING
Sacramento
University of California-San Francisco Medical Center
RECRUITING
San Francisco
Colorado
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
RECRUITING
Denver
Illinois
Rush University, Department of Neurosurgery
RECRUITING
Chicago
Kansas
University of Kansas Medical Center, Department of Orthopedic Surgery
RECRUITING
Kansas City
Kentucky
Leatherman Spine Center, Department of Orthopedic Surgery
RECRUITING
Louisville
Maryland
Johns Hopkins University, Department of Neurological Surgery
RECRUITING
Baltimore
Michigan
University of Michigan, Department of Neurosurgery
COMPLETED
Ann Arbor
Missouri
Washington University, Department of Orthopedic Surgery
RECRUITING
St Louis
North Carolina
Duke University Health System
RECRUITING
Durham
New York
Columbia University Medical Center
RECRUITING
New York
Hospital for Special Surgery, Department of Orthopedic Surgery
RECRUITING
New York
New York University, Department of Orthopedic Surgery
RECRUITING
New York
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Texas
Medical City Spine Hospital - Southwest Scoliosis Institute
RECRUITING
Dallas
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Christine Baldus, MS
baldusc@wustl.edu
6184444130
Backup
Ray Pinteric
ray.pinteric@outlook.com
Time Frame
Start Date: 2019-08-01
Estimated Completion Date: 2033-07-31
Participants
Target number of participants: 200
Treatments
Operative
Inclusion criteria:~1. ≥18 years old at time of treatment~2. Diagnosis of cervical deformity- must meet one or more of the following criteria:~ * C2-C7 sagittal kyphosis (Cobb \> 15o)~ * T1S-CL \> 35o~ * Segmental cervical kyphosis \> 10o between any 2 vertebra between C2-T1 or \> 15o across any 3 vertebra between C2-T1~ * Cervical scoliosis \> 10o (Cobb angle must include end vertebra within the cervical spine)~ * C2-C7 SVA \> 4cm~ * McGregor's slope \> 20 degrees or CBVA \> 25 degrees~3. Plan for surgical correction of cervical deformity in the next 6 months
Authors
Paul Park, Frank Schwab, Eric Klineberg
Related Therapeutic Areas
Scoliosis
Kyphosis
Sponsors
Collaborators: DePuy Synthes, Orthofix Inc.
Leads: International Spine Study Group Foundation

This content was sourced from clinicaltrials.gov

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