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Cervical StenosisNCT07877766

Assessing Microbiome in Primary Anterior Cervical Fusion Patients

A study testing Primary Anterior Cervical Discectomy Procedures in people with Cervical Stenosis and Myelopathy, run by Hospital for Special Surgery, New York at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Patients who are about to undergo cervical fusion surgery at Hospital for Special Surgery (HSS) are being asked to take part in this research study. The purpose of this study is to better understand the presence of bacteria in cervical spine surgery, using next-generation sequencing to identify bacteria in swab… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Primary Anterior Cervical Discectomy Procedures
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteUnited States
Study dates
14 Oct 2025to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 80 years.
  • Indicated for primary anterior cervical discectomy and fusion involving one to three contiguous cervical levels.
  • 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.
  • Medically cleared for surgery.
  • Able to understand the study requirements and provide written informed consent.

Who cannot join

  • Have an active systemic infection or evidence of infection at the operative site.
  • Have a history of or anticipated treatment for active systemic infection, including HIV or hepatitis C.
  • Have congenital bony or spinal cord abnormalities that affect cervical spine stability, including but not limited to congenital fusion anomalies.
  • Have prior trauma to the cervical spine (C3-C7) resulting in significant bony, ligamentous, or spinal cord injury.
  • Have had any prior cervical spine surgery at the operative level.
  • Have had a prior cervical fusion procedure at any level.
Show all 23Show fewer
  • 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.
  • Have active malignancy or a history of invasive malignancy, except for non-melanoma skin cancer.
  • Have known allergies to cobalt, chromium, molybdenum, nickel, or polyethylene.
  • Are pregnant or breastfeeding at the time of enrollment, or plan to become pregnant within three years following surgery.
  • Have rheumatoid arthritis, lupus, or other autoimmune diseases affecting the musculoskeletal system.
  • Have a Body Mass Index (BMI) greater than 40 kg/m².
  • Have medical or neurologic conditions that would preclude accurate clinical evaluation or compliance with follow-up (e.g., neuromuscular disorders).
  • Require chronic daily high-dose oral or inhaled corticosteroids or other immunosuppressive therapies.
  • Have a current or recent history (within one year prior to screening) of substance abuse, including alcoholism or narcotic addiction, requiring intervention.
  • Have used another investigational drug or medical device within 30 days prior to surgery.
  • Are taking medications known to interfere with bone or soft-tissue healing, including high-dose corticosteroids, immunosuppressive agents, or chemotherapeutic drugs.
  • Have pending personal litigation related to spinal injury (workers' compensation is not an exclusion).
  • Anticipate relocation greater than 50 miles that may interfere with completion of required follow-up visits.
  • 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.
  • Have an uncontrolled seizure disorder.
  • Have a history or evidence of psychosocial disorders that could interfere with accurate completion of self-reported outcome measures or adherence to the protocol.
  • Insulin-dependent diabetes mellitus or other medical conditions that significantly increase surgical risk or impair healing.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Hospital for Special Surgery

    New York, New York, 10021

Other trials in United States

About this study

Patients who are about to undergo cervical fusion surgery at Hospital for Special Surgery (HSS) are being asked to take part in this research study. The purpose of this study is to better understand the presence of bacteria in cervical spine surgery, using next-generation sequencing to identify bacteria in swab samples. A total of 76 participants will take part in this study at HSS.

Read the detailed description

With the introduction of instrumentation, free-flowing bacteria can potentially collect in the biofilm formation. In this context, "free-flowing bacteria" refers to bacteria that are not contained within tissue or biofilm and can circulate in the fluids surrounding surgical implants. These bacteria can potentially colonize the implant and contribute to biofilm formation. As for the culture methodologies, the investigators will be using traditional microbiology cultures, including aerobic and anaerobic cultures, to grow and identify bacteria that are free-flowing and potentially could form biofilms on the implant surfaces. The cultures would be assessed by two different methodologies with the ultimate goal of understanding if the current microbiology methodology fully elucidates the bacterial flora compared to advanced metagenomic methodology. Ultimately, the investigators hope to improve primary surgical outcomes.

Being tested
Primary Anterior Cervical Discectomy Procedures
Keywords
Microbiome, primary ACDF
Medical subject headings
Spinal Cord Diseases, Intervertebral Disc Degeneration, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Primary Anterior Cervical Discectomy ProceduresProcedure or surgery

    Clinical swabs will be taken during the anterior cervical surgery to assess bacterial presence at the surgical site.

Study groups in NCT07877766
Study groupRoleWhat they receive
Primary Anterior Cervical Discectomy ProceduresExperimentalAdults undergoing primary anterior cervical discectomy and fusion (ACDF) involving one to three contiguous cervical levels. Clinical swabs will be collected from the surgical site during surgery and analyzed by standard microbiologic culture and by metagenomic next-generation sequencing (mNGS).
Receives: Procedure: Primary Anterior Cervical Discectomy Procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metagenomic sequencing to assess bacterial presence

    Metagenomic sequencing will be compared to microbiological cultures

    Measured: perioperative

Secondary outcomes (5)

  1. Visual Analog Scale (VAS) for Neck and Arm Pain

    Neck pain and arm pain (left and right arms rated separately) will be assessed using a 100 mm Visual Analog Scale (VAS). Scores range from 0 mm (no pain) to 100 mm (worst possible pain). Higher scores indicate more severe pain (a worse outcome).

    Measured: Up to 1 year postoperatively

  2. Neck Disability Index (NDI) Score

    The Neck Disability Index (NDI) is a 10-item questionnaire that measures how neck pain affects daily activities. Each item is scored from 0 to 5, and the total score (0 to 50) is expressed as a percentage ranging from 0% (no disability) to 100% (complete disability). Higher scores indicate greater disability (a worse outcome).

    Measured: Up to 1 year postoperatively

  3. Number of Participants With Radiographic Fusion

    Fusion status at the operative level(s) will be assessed using standard-of-care postoperative plain radiographs (X-ray) and computed tomography (CT) scans.

    Measured: Up to 1 year postoperatively

  4. Number of Participants With Radiographic Evidence of Screw Lucency or Loosening

    Radiographic evidence of lucency (radiolucency) around screws or implant loosening at the operative level(s) will be assessed using standard-of-care postoperative plain radiographs (X-ray) and computed tomography (CT) scans.

    Measured: Up to 1 year postoperatively

  5. Adverse events

    To categorize any surgery-related adverse events

    Measured: Up to 1 year postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2026
  2. Study start14 Oct 2025
  3. Primary completion20 May 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07877766
Sponsor's protocol ID
2023-1514
Status last verified
Oct 2026
First submitted
17 Aug 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared with other researchers.

Publications

  • Callanan TC, Abjornson C, DiCarlo E, Henry M, Sama AA, Girardi FP, Schroeder J, Kiely P, Lebl DR, Cammisa FP Jr. Prevalence of Occult Infections in Posterior Instrumented Spinal Fusion. Clin Spine Surg. 2021 Feb 1;34(1):25-31. doi: 10.1097/BSD.0000000000001014.

    PubMed 32453165

Questions about this trial

What is this clinical trial studying?

A study testing Primary Anterior Cervical Discectomy Procedures in people with Cervical Stenosis and Myelopathy, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metagenomic sequencing to assess bacterial presence (time frame: perioperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07877766, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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