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NCT06938607 · ClinicalTrials.gov registry record
Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement
A clinical trial, sponsored by University of Nebraska.
- Not yet
- Registry status
- 360
- Enrollment target
NCT06938607: Clinical Trial study, sponsored by University of Nebraska.
NCT06938607 is a clinical trial that has not yet begun recruiting, run by University of Nebraska. The registered enrollment target is 360 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06938607 has not yet begun recruiting, sponsored by University of Nebraska.
- NOT YET RECRUITING
- Registry status
- 360 participants
- Enrollment target
Study 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. 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 placemen
Primary Outcome
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.
Interventions
- DEVICE Drain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2026-06 |
| Est. Completion | 2029-06 |
What is known before NCT06938607 opens enrollment
NCT06938607 is an observational study that tracks outcomes without assigning an intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Drain is the first listed.
NCT06938607 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06938607 about?
NCT06938607 is a clinical study titled "Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement". 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 a...
What is the current status of trial NCT06938607?
This trial is currently not yet recruiting. The enrollment target is 360 participants. The study started on 2026-06. Estimated completion is 2029-06.
What interventions are being tested in trial NCT06938607?
The interventions under investigation include: Drain (DEVICE).
Who is sponsoring clinical trial NCT06938607?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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