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

NCT04194996 | Recruiting

• 1 other identifier: 2131
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 16

Brief Summary

Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 year follow-up

• Neck Disability Index (NDI)

  Patient reported neck disability tool

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

• Veterans RAND 12 Item Health Survey (VR-12)

  Patient reported outcome

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety

  Computer adaptive PROs

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Depression

  Computer adaptive PROs

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference

  Computer adaptive PROs

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function

  Computer adaptive PROs

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (Role)

  Computer adaptive PROs

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)

  Computer adaptive PROs

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 year follow-up

Secondary Outcomes (6)

• EAT-10

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

• Voice Handicap Index (VHI-10)

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

• Adverse evnts

  3 months and 1, 2, 5 & 10 year post treatment

• Edmonton Frail Scale

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

• CHSF Frail Scale

  Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

Study Arms (1)

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

Procedure: Surgical intervention

Interventions

Surgical intervention PROCEDURE

Surgical interventions 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

Spine Surgeon Clinic

You may qualify if:

• ≥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 OR
• Planned Revision surgery for proximal junctional failure with an anticipated UIV in the cervical spine and an anticipated LIV in the thoracic or lumbar spine.
• 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
• Upright AP/Lateral entire spine (EOS or 36")
• Upright AP/Lateral C spine ONLY IF C spine is not completely visible on entire spine films
• Flex/Ext lateral C spine. Admin may allow exceptions w/ valid documentation.

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

• DePuy Synthes: collaborator
• Orthofix Inc.: collaborator
• International Spine Study Group Foundation: lead

Study Sites (16)

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

La Jolla, California, 92037, United States

RECRUITING

University of California Davis, Department of Orthopedic Surgery

Sacramento, California, 95817, United States

ACTIVE NOT RECRUITING

University of California-San Francisco Medical Center

San Francisco, California, 94143, United States

RECRUITING

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

Denver, Colorado, 80128, United States

RECRUITING

Rush University, Department of Neurosurgery

Chicago, Illinois, 60612, United States

WITHDRAWN

University of Kansas Medical Center, Department of Orthopedic Surgery

Kansas City, Kansas, 66160, United States

RECRUITING

Leatherman Spine Center, Department of Orthopedic Surgery

Louisville, Kentucky, 40202, United States

RECRUITING

Johns Hopkins University, Department of Neurological Surgery

Baltimore, Maryland, 21224, United States

RECRUITING

University of Michigan, Department of Neurosurgery

Ann Arbor, Michigan, 48109, United States

COMPLETED

Hospital for Special Surgery, Department of Orthopedic Surgery

New York, New York, 10003, United States

RECRUITING

New York University, Department of Orthopedic Surgery

New York, New York, 10003, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Duke University Health System

Durham, North Carolina, 27708, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

Medical City Spine Hospital - Southwest Scoliosis Institute

Dallas, Texas, 75243, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Kyphosis; Scoliosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Justin Smith, MD

  University of Virginia, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

• Christopher Ames, MD

  University of California, San Francisco, Department on Neurosurgery

  PRINCIPAL INVESTIGATOR

• Christopher I Shaffrey, MD

  Duke University, Departments of Neurosurgery and Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Baldus, MS

CONTACT

6184444130; baldusc@wustl.edu

Ray Pinteric

CONTACT

ray.pinteric@outlook.com

Study Design

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

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 11, 2019
• Study Start: August 1, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)