DNA sequencing peers into the hidden bacteria of spine surgery

NCT ID NCT07877766

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

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

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Hospital for Special Surgery

    New York, New York, 10021, United States

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