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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 is a clinical trial that has not yet begun recruiting, run by University of Nebraska. The registered enrollment target is 360 participants.
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
Interventions
- DEVICE Drain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2026-06 |
| Est. Completion | 2029-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06938607
The ClinicalTrials.gov registry entry for NCT06938607 describes a study currently listed as not yet recruiting, categorized as an unspecified phase. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Drain is the first listed.
NCT06938607 reports 0 study locations.
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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