Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0 (PCD 2)

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

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

Study Overview

• Status: Recruiting
• Conditions: Cervical Deformity
• Intervention / Treatment: Procedure: Surgical intervention

Detailed Description

Adult cervical deformity (ACD) is an uncommon but potentially severely debilitating condition with a broad range of causes that include but are not limited to spondylosis, inflammatory arthropathy, trauma, infection, iatrogenic, neoplastic, congenital, and neuromuscular processes. In general, sagittal plane deformities typically produce kyphosis, and coronal plane deformities result in scoliosis. Cervical kyphotic deformities are most commonly encountered in the setting of prior surgical destabilization, while cervical scoliosis is most commonly associated with congenital and neuromuscular conditions.

Cervical kyphosis may be progressive and can result in neurological symptoms, including myelopathy. The most severe forms, such as those associated with spondylotic arthropathies, can produce "chin-on-chest" deformity, which can compromise horizontal gaze, swallowing, and breathing. Even in the absence of these conditions, cervical deformity is often associated with pain and functional disability. For adult thoracolumbar deformities, substantial efforts have been made to characterize clinical presentations, develop standardized classification systems, define optimal treatment approaches, describes operative complication rates, and to present structured clinical outcomes. However, despite the potential for profound impact of cervical deformity on function and health-related quality of life, there remains a remarkable paucity of high-quality studies that address these complex conditions.

Health professionals providing nonoperative and surgical care for these patients are left to make important treatment decisions based on a combination of personal experience, anecdotal experience of colleagues and experts, and relatively small, often single-surgeon or single-center, retrospective case reports or case series in the literature. Recent systematic reviews have high-lighted the lack of studies relevant to cervical deformity and have failed to identify any prospective studies.

The International Spine Study Group (ISSG) consists of orthopedic and neurological spine surgeons with a practice emphasis on spinal deformity patients. These surgeons, from 12 busy surgical centers, meet regularly to design and perform clinical research focused on spinal deformity, including successful prospective enrollment of more than 1,000 adult thoracolumbar deformity patients into the ISSG database. This group has a proven track record and regularly presents a substantial number of abstracts to the major spine meetings and has an extensive publication record.

The ISSG members have currently enrolled more than 150 patients into the first generation prospective cervical deformity database and have produced approximately 50 abstracts and more than 25 manuscripts to date with the resulting data. The group has learned extensively from this first-generation database, but there is much yet to learn, as the literature remains relatively sparse on the topic of adult cervical deformity. Based on what we have learned from the first generation database; we have substantially modified the inclusion criteria for this second generation database. In addition, several new outcomes measures and functional assessments will be collected at baseline and follow-up intervals as part of this current proposal.

The resources of the ISSG offer an unprecedented opportunity to create a prospectively collected multicenter database of cervical deformity patients that includes standardized health-related quality of life measures at baseline and regular follow-up, clinical and surgical parameters, and complications. The database and questionnaires have been carefully redesigned based on what we have learned in order to better collect data that will help to clarify many of the unresolved issues that are important for the care of cervical deformity patients. This project has substantial potential to significantly impact the field of cervical deformity and the care of deformity patients beyond what we have already been able to accomplish based on the first generation cervical deformity database. Herein we propose the second iteration for this project that promises to further advance our evolving understanding of these complex deformities.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Christine Baldus, MS; Phone Number: 6184444130; Email: baldusc@wustl.edu
• Study Contact Backup: Name: Ray Pinteric; Email: ray.pinteric@outlook.com

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • Shiley Center for Orthopaedic Research and Education at Scripps Clinic
      • Principal Investigator: Robert Eastlack, MD
      • Sub-Investigator: Gregory Mundis, MD
      • Contact: Tina Iannacone, MPH; Phone Number: 858-554-7124; Email: iannacone.tina@scrippshealth.org
      • Contact: Julie McCauley, MPH; Email: McCauley.Julie@scrippshealth.org
    • Sacramento, California, United States, 95817
      • Active, not recruiting
      • University of California Davis, Department of Orthopedic Surgery
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California-San Francisco Medical Center
      • Principal Investigator: Christopher Ames, MD
      • Sub-Investigator: Vedat Deviren, MD
      • Contact: Terry Nguyen; Email: terry.nguyen@ucsf.edu
  • Colorado
    • Denver, Colorado, United States, 80128
      • Recruiting
      • Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
      • Contact: Breton Line, BS; Phone Number: 303-762-3472; Email: breton.line@healthonecares.com
      • Principal Investigator: Shay Bess, MD
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University, Department of Neurosurgery
      • Principal Investigator: Vince Traynelis, MD
      • Contact: Reehan Malhance; Email: Reehan_T_Malhance@rush.edu
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center, Department of Orthopedic Surgery
      • Contact: Stephanie Robinson; Phone Number: 913-588-0581; Email: srobinson6@kumc.edu
      • Principal Investigator: Douglas Burton, MD
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Leatherman Spine Center, Department of Orthopedic Surgery
      • Contact: Morgan Brown; Email: morgan.brown2@nortonhealthcare.org
      • Principal Investigator: Jeffrey Gum, MD
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins University, Department of Neurological Surgery
      • Principal Investigator: Khaled Kebaish, MD
      • Contact: Andrew Kim; Email: akim172@jh.edu
      • Sub-Investigator: Sang Lee, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Completed
      • University of Michigan, Department of Neurosurgery
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University, Department of Orthopedic Surgery
      • Sub-Investigator: Munish Gupta, MD
      • Contact: Alison Hageman; Email: hageman@wustl.edu
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
      • Contact: Meghana Vulapalli; Email: mv2748@cumc.columbia.edu
      • Principal Investigator: Daniel K Riew, MD
    • New York, New York, United States, 10003
      • Recruiting
      • New York University, Department of Orthopedic Surgery
      • Contact: Connie Maglaras; Email: constance.maglaras@nyulangone.org
      • Sub-Investigator: Peter Passias, MD
      • Principal Investigator: Themistocles Protopsaltis, MD
    • New York, New York, United States, 10003
      • Recruiting
      • Hospital for Special Surgery, Department of Orthopedic Surgery
      • Principal Investigator: Han Jo Kim, MD
      • Contact: Desmarie Sherwood; Email: sherwoodd@hss.edu
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Health System
      • Contact: Ronald Pegues; Email: ronald.pegues@duke.edu
      • Sub-Investigator: Khoi Than
      • Principal Investigator: Christopher I Shaffrey, MD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Lauren Puccio; Email: pucciolm@upmc.edu
      • Principal Investigator: Thomas Buell, MD
  • Texas
    • Dallas, Texas, United States, 75243
      • Recruiting
      • Medical City Spine Hospital - Southwest Scoliosis Institute
      • Principal Investigator: Richard Hostin, MD
      • Contact: Brenda Olivares; Email: brenda.olivares@hcahealthcare.com
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Contact: Lorrie Sipe; Phone Number: 434-924-8775; Email: lag3k@virginia.edu
      • Principal Investigator: Justin Smith, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Spine Surgeon Clinic

Description

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Operative; Inclusion criteria: ≥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 > 15o)T1S-CL > 35oSegmental cervical kyphosis > 10o between any 2 vertebra between C2-T1 or > 15o across any 3 vertebra between C2-T1Cervical scoliosis > 10o (Cobb angle must include end vertebra within the cervical spine)C2-C7 SVA > 4cmMcGregor's slope > 20 degrees or CBVA > 25 degrees; Plan for surgical correction of cervical deformity in the next 6 months

Procedure: Surgical intervention; Surgical interventions will be patient specified by treating surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EAT-10	Measures swallowing difficulties as reported by the patient.	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Voice Handicap Index (VHI-10)	Measures voice handicap as reported by the patient.	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Adverse evnts	Any adverse events occurring & meeting study established reporting criteria	3 months and 1, 2, 5 & 10 year post treatment
Edmonton Frail Scale	Frailty scale from 0 to 17 where the higher the score the more frail the patient	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
CHSF Frail Scale	Clinical Frailty Scale from 1 to 9 where the higher the score, the more frail the patient	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Dynamometer Hand Grip Strength test	With patient seated, patient will squeeze dynamometer as hard as he/she can with each hand.	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up

Collaborators and Investigators

• Sponsor: International Spine Study Group Foundation
• Collaborators: Orthofix Inc.; DePuy Synthes
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): July 31, 2033

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Scoliosis; Kyphosis; Cervical deformity
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No