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

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ClinicalTrials.gov Identifier: NCT04194996
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : May 6, 2021
Sponsor:
Collaborators:
DePuy Synthes
Orthofix Inc.
Information provided by (Responsible Party):
International Spine Study Group Foundation

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

Condition or disease Intervention/treatment
Cervical Deformity Procedure: Surgical intervention

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2032
Estimated Study Completion Date : July 31, 2033

Group/Cohort Intervention/treatment
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
Surgical interventions will be patient specified by treating surgeon.




Primary Outcome Measures :
  1. Pain Numeric rating scale (NRS) - Headaches [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Self-reported pain in Head where 0=no pain/10=severe pain

  2. Pain Numeric rating scale (NRS) - Neck [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Self-reported pain in Neck where 0=no pain/10=severe pain

  3. Pain Numeric rating scale (NRS) - Upper extremity [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Self-reported pain in Arms where 0=no pain/10=severe pain

  4. Pain Numeric rating scale (NRS) - Lower extremity [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Self-reported pain in Legs where 0=no pain/10=severe pain

  5. Pain Numeric rating scale (NRS) - Back [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Self-reported pain in Back where 0=no pain/10=severe pain

  6. Neck Disability Index (NDI) [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Patient reported neck disability tool

  7. Veterans RAND 12 Item Health Survey (VR-12) [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Patient reported outcome

  8. Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Computer adaptive PROs

  9. Patient-Reported Outcome Measurement Information System (PROMIS) - Depression [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Computer adaptive PROs

  10. Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Computer adaptive PROs

  11. Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Computer adaptive PROs

  12. Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (Role) [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Computer adaptive PROs

  13. Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA) [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Computer adaptive PROs

  14. Spine Radiographs [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    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.

  15. Modified Japanese Orthopaedic Association Scale (mJOA) [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Patient reported outcome measuring functional status using scale of 0 to 18. The higher the score, the less disability.


Secondary Outcome Measures :
  1. EAT-10 [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Measures swallowing difficulties as reported by the patient.

  2. Voice Handicap Index (VHI-10) [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Measures voice handicap as reported by the patient.

  3. Adverse evnts [ Time Frame: 3 months and 1, 2, 5 & 10 year post treatment ]
    Any adverse events occurring & meeting study established reporting criteria

  4. Edmonton Frail Scale [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Frailty scale from 0 to 17 where the higher the score the more frail the patient

  5. CHSF Frail Scale [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    Clinical Frailty Scale from 1 to 9 where the higher the score, the more frail the patient

  6. Dynamometer Hand Grip Strength test [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
    With patient seated, patient will squeeze dynamometer as hard as he/she can with each hand.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Spine Surgeon Clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194996


Contacts
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Contact: Christine Baldus, MS 6184444130 baldusc@wustl.edu
Contact: Ray Pinteric ray.pinteric@outlook.com

Locations
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United States, California
Shiley Center for Orthopaedic Research and Education at Scripps Clinic Recruiting
La Jolla, California, United States, 92037
Contact: Tina Iannacone, MPH    858-554-7124    iannacone.tina@scrippshealth.org   
Contact: Tina McCauley, MPH       McCauley.Julie@scrippshealth.org   
Principal Investigator: Robert Eastlack, MD         
Sub-Investigator: Gregory Mundis, MD         
University of California Davis, Department of Orthopedic Surgery Not yet recruiting
Sacramento, California, United States, 95817
Contact: Lauren Agatstein, MA    916-551-3242    lagatstein@ucdavis.edu   
Principal Investigator: Eric Klineberg, MD         
University of California-San Francisco Medical Center Not yet recruiting
San Francisco, California, United States, 94143
Contact: Dennis Lambert       dennis.lambert@ucsf.edu   
Principal Investigator: Christopher Ames, MD         
Sub-Investigator: Vedat Deviren, MD         
United States, Colorado
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80128
Contact: Breton Line, BS    303-762-3472    breton.line@healthonecares.com   
Principal Investigator: Shay Bess, MD         
United States, Illinois
Rush University, Department of Neurosurgery Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Corey Woods       Corey_J_Woods@rush.edu   
Contact: ewa Gliwa       ewa_gliwa@rush.edu   
Principal Investigator: Vince Traynelis, MD         
United States, Kansas
University of Kansas Medical Center, Department of Orthopedic Surgery Recruiting
Kansas City, Kansas, United States, 66160
Contact: Stephanie Robinson    913-588-0581    srobinson6@kumc.edu   
Principal Investigator: Douglas Burton, MD         
United States, Kentucky
Leatherman Spine Center, Department of Orthopedic Surgery Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Morgan Brown       morgan.brown2@nortonhealthcare.org   
Principal Investigator: Jeffrey Gum, MD         
United States, Maryland
Johns Hopkins University, Department of Neurological Surgery Recruiting
Baltimore, Maryland, United States, 21224
Contact: Emmanuel McNeely       emcneel4@jhmi.edu   
Principal Investigator: Khaled Kebaish, MD         
United States, Michigan
University of Michigan, Department of Neurosurgery Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Karen Sagher       kfrisch@med.umich.edu   
Principal Investigator: Paul Park, MD         
United States, Missouri
Washington University, Department of Orthopedic Surgery Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Colleen Peters       petersc@wustl.edu   
Sub-Investigator: Munish Gupta, MD         
Principal Investigator: Michael P Kelly, MD         
United States, New York
Hospital for Special Surgery, Department of Orthopedic Surgery Not yet recruiting
New York, New York, United States, 10003
Contact: Tom Ross, RN       rosst@hss.edu   
Principal Investigator: Han Jo Kim, MD         
Sub-Investigator: Frank Schwab, MD         
New York University, Department of Orthopedic Surgery Recruiting
New York, New York, United States, 10003
Contact: Brooke O'Connell         
Sub-Investigator: Peter Passias, MD         
Principal Investigator: Themistocles Protopsaltis, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Meghana Vulapalli       mv2748@cumc.columbia.edu   
Principal Investigator: Daniel K Riew, MD         
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Karen Grace, RN    919-613-3801    Karen.grace@duke.edu   
Principal Investigator: Christopher I Shaffrey, MD         
United States, Texas
Medical City Spine Hospital - Southwest Scoliosis Institute Recruiting
Dallas, Texas, United States, 75243
Contact: Julia Kincaide, MPH    214-556-0578    Julia.Kincaide@HCAhealthcare.com   
Principal Investigator: Richard Hostin, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Lorrie Sipe    434-924-8775    lag3k@virginia.edu   
Principal Investigator: Justin Smith, MD         
Sponsors and Collaborators
International Spine Study Group Foundation
DePuy Synthes
Orthofix Inc.
Investigators
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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
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Responsible Party: International Spine Study Group Foundation
ClinicalTrials.gov Identifier: NCT04194996    
Other Study ID Numbers: 2131
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Spine Study Group Foundation:
Cervical deformity
Kyphosis
Scoliosis
Additional relevant MeSH terms:
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Congenital Abnormalities