Enrolling by invitationNCT07877766Updated Oct 16, 2026

Assessing Microbiome in Primary Anterior Cervical Fusion Patients

An interventional study of Primary Anterior Cervical Discectomy Procedures in Cervical Stenosis, Myelopathy and Cervical Spondylosis With Myelopathy, sponsored by Hospital for Special Surgery, New York. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Hospital for Special Surgery, New York · Not applicable, Interventional, and Diagnostic

From the registry’s dates

Registered 10 months after the study started (first participant enrolled Oct 2025, registered Aug 2026).

Updated Oct 16, 2026Newly registeredGo to Updates ↓

Phase: Not applicable
Study type: Interventional
Enrollment: 76
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study 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 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.

Conditions studied

Cervical Stenosis
Myelopathy
Cervical Spondylosis With Myelopathy
Degenerative Disc Disease
Radiculopathy

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Keywords

Microbiome
primary ACDF

In context

Spinal Cord Diseases

204 studies on the registry are indexed under Spinal Cord Diseases; 53 are open to participants now.

This study's planned enrollment of 76 is above the median of 40 across 140 interventional studies indexed under Spinal Cord Diseases.

Browse Spinal Cord Diseases studies →

Lead sponsor

Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.

Browse Hospital for Special Surgery, New York studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 76 participants (estimated)

Study arms

Experimental
Primary Anterior Cervical Discectomy Procedures
Adults 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).
Procedure: Primary Anterior Cervical Discectomy Procedures

Interventions

ProcedurePrimary Anterior Cervical Discectomy Procedures
Clinical swabs will be taken during the anterior cervical surgery to assess bacterial presence at the surgical site.

What researchers measure

Primary outcomes

Metagenomic sequencing to assess bacterial presence
Metagenomic sequencing will be compared to microbiological cultures
Time frame: perioperative

Secondary outcomes

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).
Time frame: Up to 1 year postoperatively
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).
Time frame: Up to 1 year postoperatively
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.
Time frame: Up to 1 year postoperatively
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.
Time frame: Up to 1 year postoperatively
Adverse events
To categorize any surgery-related adverse events
Time frame: Up to 1 year postoperatively

Study locations

1 site

Hospital for Special Surgery
New York, New York 10021, United States

References and documents

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 ↗

Study documents

Study protocol · Aug 15, 2026
Informed consent form · Oct 9, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared with other researchers.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for May 2027, 19 months after the start.

Of 59 non-industry interventional studies with no phase under Spinal Cord Diseases, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 75. This study's planned 19 months is below that.

Counting every sponsor, half of 64 studies reached it within 48 months; a quarter within 20 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 17, 2026
First posted: Oct 16, 2026
StartActual: Oct 14, 2025
Primary completionEst.: May 20, 2027
CompletionEst.: Jul 1, 2027
Last update: Oct 16, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 16, 2026

Show all 1 update

Oct 16, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07877766
Lead sponsor: Hospital for Special Surgery, New York
Responsible party: Sponsor
First posted: Oct 16, 2026
Start date: Oct 14, 2025
Primary completion: May 20, 2027 (estimated)
Completion: Jul 1, 2027 (estimated)
Last update: Oct 16, 2026

Study contacts

Frank P Cammisa, MD

principal investigator · Hospital for Special Surgery, New York

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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