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NCT01383876 · ClinicalTrials.gov registry record · NA
Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion
A NA study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT01383876 is a NA study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 11 participants.
The verdict
NCT01383876, a NA study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
Cervical collars are commonly used to provide external immobilization after elective Posterior Cervical Laminectomy and Interbody Fusion (PCLIF). The rationale for collar use is the perception and assumption that it can prevent early instrumentation failure and promote successful spinal fusion. However, there are a number of potential complications associated with cervical collars such as skin breakdown, ulceration, neck pain, impedance upon activities of daily living, and impaired swallowing. Considering these conflicting factors, there is wide disagreement among spinal surgeons about the utility, benefits, and necessity of collar use following elective PCLIF. Hypothesis: Wearing a cervical collar for 12 weeks after posterior cervical laminectomy and instrumented fusion will not demonstrate substantial benefits as measured by the incidence of instrumentation failure, rate of nonunion, or clinical outcome measures. Specific Aim I: To compare the outcomes of surgery in patients who will wear a cervical collar for 12 weeks following surgery versus those who will have the collar removed prior to discharge after surgery.
Interventions
- BEHAVIORAL Collar
- BEHAVIORAL No Collar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01383876
The ClinicalTrials.gov registry entry for NCT01383876 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Collar is the first listed.
NCT01383876 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01383876 about?
NCT01383876 is a clinical study titled "Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion". Cervical collars are commonly used to provide external immobilization after elective Posterior Cervical Laminectomy and Interbody Fusion (PCLIF). The rationale for collar use is the perception and assumption that it can prevent early instrumentation failure and promote successful spinal fusion. Howe...
What is the current status of trial NCT01383876?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2011-06. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01383876?
The interventions under investigation include: Collar (BEHAVIORAL), No Collar (BEHAVIORAL).
Who is sponsoring clinical trial NCT01383876?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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