Surgical Treatment for Cervical Deformity Study
This study is looking at how well surgery works for people with cervical deformity (a problem with the natural curve of your neck). It's an observational study, meaning researchers will follow patients who are already getting surgery for this condition. The goal is to see how surgery affects pain in the head, neck, and arms over time. You might be able to join if you are at least 18 years old and have a diagnosis of cervical deformity, which includes specific measurements of neck curvature. Researchers plan to include about 200 people in this study. The current status of this study is unclear.
- Study design
- This is an observational study, meaning researchers will follow patients who are already receiving surgical treatment. It aims to include about 200 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 10 years after surgery, with check-ups at 3 months, 6 months, and 1, 2, 5, and 10 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0
At a glance
Conditions
NCT04194996
Where you'd take part
This study runs at 16 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Columbia University Medical Center
New York, New Yorkstudy coordinator listed
Recruiting
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Coloradostudy coordinator listed
Recruiting
Duke University Health System
Durham, North Carolinastudy coordinator listed
Recruiting
Hospital for Special Surgery, Department of Orthopedic Surgery
New York, New Yorkstudy coordinator listed
Recruiting
Johns Hopkins University, Department of Neurological Surgery
Baltimore, Marylandstudy coordinator listed
Recruiting
Leatherman Spine Center, Department of Orthopedic Surgery
Louisville, Kentuckystudy coordinator listed
Recruiting
Medical City Spine Hospital - Southwest Scoliosis Institute
Dallas, Texasstudy coordinator listed
Recruiting
New York University, Department of Orthopedic Surgery
New York, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Justin Smith, MD · PRINCIPAL_INVESTIGATOR · University of Virginia, Department of Neurosurgery
- Christopher Ames, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco, Department on Neurosurgery
- Christopher I Shaffrey, MD · PRINCIPAL_INVESTIGATOR · Duke University, Departments of Neurosurgery and Orthopaedic Surgery
Who to contact
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Inclusion
Exclusion
What this trial measures
- Pain Numeric rating scale (NRS) - HeadachesChange 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) - NeckChange 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 extremityChange 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 extremityChange 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) - BackChange 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)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)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) - AnxietyChange 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) - DepressionChange 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 InterferenceChange 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 FunctionChange 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)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)Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PROs
- Spine RadiographsChange 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)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.