New spine device aims to fix crooked necks
NCT ID NCT04912674
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new surgical system called Symphony for adults with severe neck deformities. About 100 patients will receive the device to straighten the spine and relieve pain. Researchers will track pain, disability, and complications for up to two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Symphony OCT System (a surgical device for spine fusion)
- What this could lead to
- If successful, this could provide a safe and effective surgical option for adults with severe neck deformities, reducing pain and improving quality of life.
- What could go wrong
- This is a non-randomized study with only 100 participants, so results may not apply to everyone. Surgery carries risks like infection, nerve damage, or device failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult cervical deformity patients from spine surgeon clinic
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ≥18 years old at time of treatment 2. Patient undergoing a posterior cervical instrumented fusion using the DePuy Synthes SymphonyTM OCT System for the treatment of adult cervical deformity, defined as any of below criteria: 1. Loss of cervical lordosis (≤ 0° cervical lordosis C2-7) 2. ≥ 5° of kyphosis across any 1 or 2 cervical segments 3. ≥ 10° of cervical scoliosis 4. C2-C7 SVA ≥ 4cm 5. T1 Slope minus Cervical Lordosis ≥ 20° 6. Grade I or greater Spondylolisthesis at any segment C1-T1 7. Horizontal Gaze ≤ 0 or ≥ 11 3. Plan for surgical correction of cervical deformity in the next 6 months 4. Willing to provide consent and complete study forms at baseline and follow-up intervals Exclusion Criteria: 1. Active spine tumor or infection 2. Deformity due to acute trauma 3. Unwilling to provide consent or to complete study forms 4. Prisoner 5. Pregnant or immediate plans to get pregnant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Colorado, 80128, United States
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Duke University
Durham, North Carolina, 27710, United States
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University of California Davis
Sacramento, California, 95817, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219, United States
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University of Virginia
Charlottesville, Virginia, 22908, United States
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Washington University
St Louis, Missouri, 63110, United States
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