Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion
Stopped early · Not applicable
Conditions studied: Cervical Spondylosis Symptomatic Neurological Compression
In brief
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.
Key facts
- Study ID
- NCT01383876
- Run by
- Brigham and Women's Hospital
- People needed
- 11
- Starts
- 2011-06-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2013-10-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older
- English Speaking
- Diagnosis of degenerative cervical spondylosis with symptomatic neurological compression (spinal cord and/or nerve root) requiring posterior decompression and instrumentation fusion
- Surgical construct to include instrumentation and fusion as proximal as C2 and as distal as T2
- Ability to provide written consent
- Ability to complete pre- and postoperative questionnaires
You may not qualify if…
- Diagnosis of malignancy, infection, fracture/dislocation of the cervical spine
- Posterior cervical constructs including the occiput or C1
- Previous cervical fusion to the occiput or C1
- Non-English speaking
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Brigham & Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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