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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: Clinical Trial NA study, sponsored by Brigham and Women's Hospital.

NCT01383876 is a NA study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

To compare the solid fusion rates between collar and no collar groups.

Interventions

  • BEHAVIORAL Collar
  • BEHAVIORAL No Collar

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2011-06
Est. Completion 2013-07
Phase NA
Brigham and Women's Hospital

937 total trials

Why NCT01383876 stopped before completion

NCT01383876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Collar is the first listed.

NCT01383876 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01383876's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01383876, the US trial registry maintained by the National Library of Medicine. NCT01383876 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.