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Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion

NCT01383876 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2013-10-22

No results posted yet for this 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.

Conditions

  • Cervical Spondylosis Symptomatic Neurological Compression

Interventions

BEHAVIORAL

Collar

Have a hard cervical collar placed in the operating room after surgery. The collar will be removed/exchanged for bathing, grooming, and dressing changes only. It will remain in place for 12 weeks.

BEHAVIORAL

No Collar

Have a hard cervical collar placed in the operating room after surgery. This will remain in place for 1 to 2 days and be discontinued prior to discharge.

Sponsors & Collaborators

Principal Investigators

  • Christopher M Bono, M.D. · Brigham & Women's Hospital, Harvard Medical School

  • Dana A Leonard, B.A. · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01383876 on ClinicalTrials.gov