NCT04194996 · International Spine Study Group Foundation
Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0
(PCD 2)
What this study is about
Multi-center, forward-looking, non-randomly assigned study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.
View original scientific description
Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.
Interventions
PROCEDURE
Surgical intervention
Surgical interventions will be patient specified by treating surgeon.
Primary outcome measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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.
Exclusion criteria
- Active spine tumor or infection
- Deformity due to acute trauma
- Unwilling to provide consent or to complete study forms
- Pregnant or immediate plans to get pregnant
Where
- La Jolla, California
- Sacramento, California
- San Francisco, California
- Denver, Colorado
- Chicago, Illinois
- Kansas City, Kansas
- Louisville, Kentucky
- Baltimore, Maryland
- Ann Arbor, Michigan
- New York, New York
- Durham, North Carolina
- Pittsburgh, Pennsylvania
And 2 more locations — see the full list below.
Collaborators
DePuy Synthes, Orthofix Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations