Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center… (NCT04194996) | Clinical Trial Compass
RecruitingNot Applicable
Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0
United States200 participantsStarted 2019-08-01
Plain-language summary
Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Prisoner
* Pregnant or immediate plans to get pregnant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Numeric rating scale (NRS) - Headaches
Timeframe: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
2
Pain Numeric rating scale (NRS) - Neck
Timeframe: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
3
Pain Numeric rating scale (NRS) - Upper extremity
Timeframe: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
4
Pain Numeric rating scale (NRS) - Lower extremity
Timeframe: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
5
Pain Numeric rating scale (NRS) - Back
Timeframe: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
6
Neck Disability Index (NDI)
Timeframe: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up