ACDF SurgeryNCT06938607
Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement
An observational study of ACDF Surgery, run by University of Nebraska at 1 site in United States.
Trial summary
Anterior Cervical Discectomy and Fusion (ACDF) is a widely performed surgical procedure used to treat cervical spondylosis and cervical disc herniations with cervical nerve root compression and or cervical spinal cord compression when conservative treatment options have been exhausted. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- ACDF Surgery
- What is being tested?
- Drain
- Type of treatment
- Medical device
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2029
- Phase
- Observational
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants scheduled to undergo a primary or revision single or multilevel anterior cervical discectomy and fusion (ACDF).
Who may be able to join
- 19-75 years of age
- Having elective anterior cervical discectomy and fusion (ACDF) surgery
Who cannot join
- Unable to stop anticoagulation medication
- Cervical (neck) cancer or tumor
- Combined anterior cervical discectomy and fusion, and posterior cervical fusion
- Active infection or trauma
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
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Chris Cornett, MD, 402-559-5626, chris.cornett@unmc.edu
About this study
Official title: Post-operative Outcomes Comparing Drain vs No Drain Placement Following Anterior Cervical Discectomy and Fusion Surgery
Anterior Cervical Discectomy and Fusion (ACDF) is a widely performed surgical procedure used to treat cervical spondylosis and cervical disc herniations with cervical nerve root compression and or cervical spinal cord compression when conservative treatment options have been exhausted. The primary aim of ACDF is to alleviate neck, shoulder, and upper extremity pain associated with degenerative cervical disc disease by removing one or more affected discs, decompressing the nerves, and restoring cervical spine anatomy through the implantation of structural allograft/autograft bone or artificial spacers, plates, and screws. Historically, ACDF has demonstrated substantial long-term benefits in pain relief and quality of life improvements for patients. In the United States alone, the annual number of ACDF procedures exceeds 150,000 and is projected to rise significantly over the next four decades. Despite its technical complexity, ACDF is considered a relatively safe procedure. Common postoperative complications include dysphagia (1.7-9.5%), hematoma (0.4-5.6%), worsening myelopathy (0.2-3.3%), recurrent laryngeal nerve palsy (0.9-3.1%), cerebrospinal fluid leakage (0.5-1.7%), and surgical site infections (0.9-1.6%). One strategy employed to mitigate postoperative complications such as hematoma, surgical site infection, and the need for reoperation is the placement of an indwelling subfascial drain within the surgical site. These drains facilitate the removal of accumulated blood or serous fluid, thereby reducing localized pressure and potentially preventing adverse outcomes. Despite its theoretical benefits, the utility of subfascial drains remains a topic of debate among surgeons. Given the limited evidence on the efficacy of subfascial drain placement following ACDF, this study proposes a randomized controlled trial to evaluate the necessity and impact of subfascial drain placement on postoperative outcomes.
This study will determine whether subfascial drain placement reduces the incidence of postoperative complications, including hematoma, infection, airway compromise and secondary surgeries, compared to no drain placement following ACDF surgery; assess the impact of subfascial drain placement on the severity and duration of postoperative dysphagia compared to no drain placement; and evaluate participant-reported outcomes and satisfaction, including postoperative pain and recovery experience, between the drain and no-drain groups.
Read the detailed description
Anterior Cervical Discectomy and Fusion (ACDF) is a widely performed surgical procedure used to treat cervical spondylosis and cervical disc herniations with cervical nerve root compression and or cervical spinal cord compression when conservative treatment options have been exhausted. The primary aim of ACDF is to alleviate neck, shoulder, and upper extremity pain associated with degenerative cervical disc disease by removing one or more affected discs, decompressing the nerves, and restoring cervical spine anatomy through the implantation of structural allograft/autograft bone or artificial spacers, plates, and screws. Historically, ACDF has demonstrated substantial long-term benefits in pain relief and quality of life improvements for patients. In the United States alone, the annual number of ACDF procedures exceeds 150,000 and is projected to rise significantly over the next four decades. Despite its technical complexity, ACDF is considered a relatively safe procedure. Common postoperative complications include dysphagia (1.7-9.5%), hematoma (0.4-5.6%), worsening myelopathy (0.2-3.3%), recurrent laryngeal nerve palsy (0.9-3.1%), cerebrospinal fluid leakage (0.5-1.7%), and surgical site infections (0.9-1.6%). One strategy employed to mitigate postoperative complications such as hematoma, surgical site infection, and the need for reoperation is the placement of an indwelling subfascial drain within the surgical site. These drains facilitate the removal of accumulated blood or serous fluid, thereby reducing localized pressure and potentially preventing adverse outcomes. Despite its theoretical benefits, the utility of subfascial drains remains a topic of debate among surgeons. Given the limited evidence on the efficacy of subfascial drain placement following ACDF, this study proposes a randomized controlled trial to evaluate the necessity and impact of subfascial drain placement on postoperative outcomes.
This study will determine whether subfascial drain placement reduces the incidence of postoperative complications, including hematoma, infection, airway compromise and secondary surgeries, compared to no drain placement following ACDF surgery; assess the impact of subfascial drain placement on the severity and duration of postoperative dysphagia compared to no drain placement; and evaluate participant-reported outcomes and satisfaction, including postoperative pain and recovery experience, between the drain and no-drain groups. Up to 360 participants will be randomly assigned to one of two groups. Those signed to the drain group will have a surgical drain placed on the surface of the wound during closure. The drain will be removed within 24 hours. Those in the no-drain group will have their wound closed without a drain. All other aspects of participants' care before and after surgery will be the same. No additional visits are required for this study. Basic information will be collected from participants' medical records, such as age, gender, type of surgery. For 180 days following surgery, participants' health will be monitored through clinical visit notes, phone calls with their doctor or clinic staff, and records of any hospital visits due to complications.
- Conditions
- ACDF Surgery
- Being tested
- Drain
- Keywords
- ACDF Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrainDevice
Participants assigned to the drain group will have a surgical drain placed on the surface of the wound during closure. The drain will be removed within 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| No-drain group | Participants assigned to the no-drain group will have their wound closed without a drain. | |
| Drain group | Participants assigned to the drain group will have a surgical drain placed on the surface of the wound during closure. The drain will be removed within 24 hours. Receives: Device: Drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Complications
Complications such as hematoma, infection, airway-compromise, and other complications will be recorded and monitored immediately after surgery and at followed-up visits, 1-2 weeks, 3 months and 6 months.
Measured: Post-surgery 1-2 weeks, 3 months and 6 months
Secondary outcomes (3)
Dysphagia Assessment EAT-10
Dysphagia, the difficulty swallowing foods or liquids, will be assessed assessed at 1-2 weeks, 3 months and 6 months,using EAT-10 assessment tool. This tool has ten questions that are rated from 0 (no problem) to 4 (severe problem). Scores of 3 or above are considered abnormal.
Measured: Post-surgery 1-2 weeks, 3 months and 6 months
Length of Hospital Stay
The total length of the post-surgical hospital stay will be obtained from medical records.
Measured: Post-surgery typically up to 1 week
Post-operative Pain Assessment
Post-operative pain will be assessed using the self-reported numerical scale (0 - no pain, 10 - worst pain imaginable) at 1-2 weeks, 3 months and 6 months.
Measured: Post-surgery 1-2 weeks, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study startNov 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACDF SurgeryStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Cornett, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938607
- Sponsor's protocol ID
- 0199-25-FB
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Outcomes Comparing Drain vs No Drain Placement Following Anterior Cervical Discectomy and Fusion Surgery
- ClinicalTrials.gov ID
- NCT06938607
- Acronym / sponsor ID
- 0199-25-FB
- Conditions
- ACDF Surgery
- Keywords
- ACDF Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anterior Cervical Discectomy and Fusion (ACDF) is a widely performed surgical procedure used to treat cervical spondylosis and cervical disc herniations with cervical nerve root compression and or cervical spinal cord compression when conservative treatment options have been exhausted. The primary aim of ACDF is to alleviate neck, shoulder, and upper extremity pain associated with degenerative cervical disc disease by removing one or more affected discs, decompressing the nerves, and restoring cervical spine anatomy through the implantation of structural allograft/autograft bone or artificial spacers, plates, and screws. Historically, ACDF has demonstrated substantial long-term benefits in pain relief and quality of life improvements for patients. In the United States alone, the annual number of ACDF procedures exceeds 150,000 and is projected to rise significantly over the next four decades. Despite its technical complexity, ACDF is considered a relatively safe procedure. Common postoperative complications include dysphagia (1.7-9.5%), hematoma (0.4-5.6%), worsening myelopathy (0.2-3.3%), recurrent laryngeal nerve palsy (0.9-3.1%), cerebrospinal fluid leakage (0.5-1.7%), and surgical site infections (0.9-1.6%). One strategy employed to mitigate postoperative complications such as hematoma, surgical site infection, and the need for reoperation is the placement of an indwelling subfascial drain within the surgical site. These drains facilitate the removal of accumulated blood or serous fluid, thereby reducing localized pressure and potentially preventing adverse outcomes. Despite its theoretical benefits, the utility of subfascial drains remains a topic of debate among surgeons. Given the limited evidence on the efficacy of subfascial drain placement following ACDF, this study proposes a randomized controlled trial to evaluate the necessity and impact of subfascial drain placement on postoperative outcomes.
This study will determine whether subfascial drain placement reduces the incidence of postoperative complications, including hematoma, infection, airway compromise and secondary surgeries, compared to no drain placement following ACDF surgery; assess the impact of subfascial drain placement on the severity and duration of postoperative dysphagia compared to no drain placement; and evaluate participant-reported outcomes and satisfaction, including postoperative pain and recovery experience, between the drain and no-drain groups.
Detailed description
Anterior Cervical Discectomy and Fusion (ACDF) is a widely performed surgical procedure used to treat cervical spondylosis and cervical disc herniations with cervical nerve root compression and or cervical spinal cord compression when conservative treatment options have been exhausted. The primary aim of ACDF is to alleviate neck, shoulder, and upper extremity pain associated with degenerative cervical disc disease by removing one or more affected discs, decompressing the nerves, and restoring cervical spine anatomy through the implantation of structural allograft/autograft bone or artificial spacers, plates, and screws. Historically, ACDF has demonstrated substantial long-term benefits in pain relief and quality of life improvements for patients. In the United States alone, the annual number of ACDF procedures exceeds 150,000 and is projected to rise significantly over the next four decades. Despite its technical complexity, ACDF is considered a relatively safe procedure. Common postoperative complications include dysphagia (1.7-9.5%), hematoma (0.4-5.6%), worsening myelopathy (0.2-3.3%), recurrent laryngeal nerve palsy (0.9-3.1%), cerebrospinal fluid leakage (0.5-1.7%), and surgical site infections (0.9-1.6%). One strategy employed to mitigate postoperative complications such as hematoma, surgical site infection, and the need for reoperation is the placement of an indwelling subfascial drain within the surgical site. These drains facilitate the removal of accumulated blood or serous fluid, thereby reducing localized pressure and potentially preventing adverse outcomes. Despite its theoretical benefits, the utility of subfascial drains remains a topic of debate among surgeons. Given the limited evidence on the efficacy of subfascial drain placement following ACDF, this study proposes a randomized controlled trial to evaluate the necessity and impact of subfascial drain placement on postoperative outcomes.
This study will determine whether subfascial drain placement reduces the incidence of postoperative complications, including hematoma, infection, airway compromise and secondary surgeries, compared to no drain placement following ACDF surgery; assess the impact of subfascial drain placement on the severity and duration of postoperative dysphagia compared to no drain placement; and evaluate participant-reported outcomes and satisfaction, including postoperative pain and recovery experience, between the drain and no-drain groups. Up to 360 participants will be randomly assigned to one of two groups. Those signed to the drain group will have a surgical drain placed on the surface of the wound during closure. The drain will be removed within 24 hours. Those in the no-drain group will have their wound closed without a drain. All other aspects of participants' care before and after surgery will be the same. No additional visits are required for this study. Basic information will be collected from participants' medical records, such as age, gender, type of surgery. For 180 days following surgery, participants' health will be monitored through clinical visit notes, phone calls with their doctor or clinic staff, and records of any hospital visits due to complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-drain group | – | –Participants assigned to the no-drain group will have their wound closed without a drain. |
| Drain group | – | Device: DrainParticipants assigned to the drain group will have a surgical drain placed on the surface of the wound during closure. The drain will be removed within 24 hours. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants scheduled to undergo a primary or revision single or multilevel anterior cervical discectomy and fusion (ACDF).
Key inclusion criteria (2 listed)
- 19-75 years of age
- Having elective anterior cervical discectomy and fusion (ACDF) surgery
Key exclusion criteria (4 listed)
- Unable to stop anticoagulation medication
- Cervical (neck) cancer or tumor
- Combined anterior cervical discectomy and fusion, and posterior cervical fusion
- Active infection or trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DrainParticipants assigned to the drain group will have a surgical drain placed on the surface of the wound during closure. The drain will be removed within 24 hours. | Device | Drain group |
Primary outcome
Surgical Complications
Time frame: Post-surgery 1-2 weeks, 3 months and 6 months
Complications such as hematoma, infection, airway-compromise, and other complications will be recorded and monitored immediately after surgery and at followed-up visits, 1-2 weeks, 3 months and 6 months.
3 secondary outcomes
Dysphagia Assessment EAT-10
Time frame: Post-surgery 1-2 weeks, 3 months and 6 months
Length of Hospital Stay
Time frame: Post-surgery typically up to 1 week
Post-operative Pain Assessment
Time frame: Post-surgery 1-2 weeks, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for ACDF Surgery
Recruiting
Function After Anterior Cervical Discectomy and Fusion Surgery: Timing of Physical Therapy
Cervical Spine Degeneration, ACDF Surgery
Recruiting
Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention
Dysphagia
Enrolling by invitation
Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures
Cervical Stenosis, Spondylolisthesis
Recruiting
Cervical Arthroplasty Cost Effectiveness Study (CACES)
Radiculopathy, Cervical, Myelopathy Cervical
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Cornett, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACDF Surgery, run by University of Nebraska 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 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?
Contact Chris Cornett, MD (402-559-5626, chris.cornett@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Complications (time frame: Post-surgery 1-2 weeks, 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.