DNA sequencing peers into the hidden bacteria of spine surgery
NCT ID NCT07877766
First seen Oct 16, 2026 · Last updated Oct 16, 2026
Summary
Researchers at the Hospital for Special Surgery are studying which bacteria are present at the surgical site during anterior cervical discectomy and fusion, a common neck surgery. They will take swabs from 76 adults during the procedure and use metagenomic sequencing, a DNA-based method, to identify bacteria. The team will compare those results with standard laboratory cultures and track neck and arm pain afterward. The goal is to better understand the bacteria involved in these surgeries, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If sequencing reveals bacteria that standard cultures miss, it could change how surgeons think about infection risk and prevention in cervical spine surgery.
- What could go wrong
- This is an observational study with no treatment, so it cannot prove that any bacterium causes problems. Swab results may reflect contamination rather than true infection, and the findings may not apply to other spine surgeries.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- 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.
- Ages
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18 to 80 years
- 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. Age between 18 and 80 years. 2. Indicated for primary anterior cervical discectomy and fusion involving one to three contiguous cervical levels. 3. Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete the required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol. 4. Medically cleared for surgery. 5. Able to understand the study requirements and provide written informed consent. Exclusion Criteria: 1. Have an active systemic infection or evidence of infection at the operative site. 2. Have a history of or anticipated treatment for active systemic infection, including HIV or hepatitis C. 3. Have congenital bony or spinal cord abnormalities that affect cervical spine stability, including but not limited to congenital fusion anomalies. 4. Have prior trauma to the cervical spine (C3-C7) resulting in significant bony, ligamentous, or spinal cord injury. 5. Have had any prior cervical spine surgery at the operative level. 6. Have had a prior cervical fusion procedure at any level. 7. Have a significantly increased risk of osteoporosis. Screening may include clinical assessment or prior bone mineral density testing. Subjects with a documented dual-energy X-ray absorptiometry (DEXA) T-score ≤ -1.5 within 24 months prior to surgery may be excluded at the discretion of the investigator. 8. Have active malignancy or a history of invasive malignancy, except for non-melanoma skin cancer. 9. Have known allergies to cobalt, chromium, molybdenum, nickel, or polyethylene. 10. Are pregnant or breastfeeding at the time of enrollment, or plan to become pregnant within three years following surgery. 11. Have rheumatoid arthritis, lupus, or other autoimmune diseases affecting the musculoskeletal system. 12. Have a Body Mass Index (BMI) greater than 40 kg/m². 13. Have medical or neurologic conditions that would preclude accurate clinical evaluation or compliance with follow-up (e.g., neuromuscular disorders). 14. Require chronic daily high-dose oral or inhaled corticosteroids or other immunosuppressive therapies. 15. Have a current or recent history (within one year prior to screening) of substance abuse, including alcoholism or narcotic addiction, requiring intervention. 16. Have used another investigational drug or medical device within 30 days prior to surgery. 17. Are taking medications known to interfere with bone or soft-tissue healing, including high-dose corticosteroids, immunosuppressive agents, or chemotherapeutic drugs. 18. Have pending personal litigation related to spinal injury (workers' compensation is not an exclusion). 19. Anticipate relocation greater than 50 miles that may interfere with completion of required follow-up visits. 20. Have mental illness or belong to a vulnerable population (e.g., prisoner or developmentally disabled) that would compromise the ability to provide informed consent or comply with study requirements. 21. Have an uncontrolled seizure disorder. 22. Have a history or evidence of psychosocial disorders that could interfere with accurate completion of self-reported outcome measures or adherence to the protocol. 23. Insulin-dependent diabetes mellitus or other medical conditions that significantly increase surgical risk or impair healing.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital for Special Surgery
New York, New York, 10021, United States
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Other studies related to the condition(s) this trial covers.
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- Can a new bone graft match the gold standard for spinal fusion?