Clinical trial NCT01383876: Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion
Official title: Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Spondylosis Symptomatic Neurological Compression
Keywords: cervical
laminectomy
fusion
neurological compression
spondylosis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2011-06-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Following the informed consent process, subjects will fill out a baseline questionnaire consisting of demographic information, visual analog scale (VAS) pain scores for neck and arm pain, and the Neck Disability Index Questionnaire (NDI).

Following surgery, the surgeon will fill out an operative data collection sheet to record information such as: levels fused, type of instrumentation, pre- and post-operative sagittal alignment, and intra-operative complications (if applicable). Subjects will be randomized into the "collar" or "no collar" group immediately following surgery, using a computer generated randomization scheme, so as not to influence the surgeon's operative technique. If the patient is randomized to the "no collar" group, he or she will actually 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. If the patient is randomized to the "collar" group, he or she will have the hard cervical collar placed after surgery. The collar will be removed/exchanged for bathing, grooming, and dressing changes only. It will remain in place for 12 weeks.

The patient will undergo usual and customary clinical and radiographic follow-up. This includes physical examination and cervical radiographs taken at 2 weeks, 12 weeks, 6 month, and 1 year. VAS and Neck Disability Index scores will be obtained at the 2 week, 12 week, 6 month, and 1 year follow-up visits. Radiographs will be assessed by a two independent radiologists for instrumentation failure (defined as any of the following: screw loosening, screw breakage, rod breakage, screw dislodgement) and fusion status. Solid fusion will be defined as bridging trabecular bone between or along the lateral masses/facet joints of the operated segments as assessed on a lateral cervical radiograph. In addition, the overall sagittal alignment of the spine will be measured. For the primary outcome of the study, final follow-up at 1 year would be considered satisfactory to determine differences in pseudarthrosis and instrumentation failure.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fusion Rates
timeFrame: 1 year
Secondary outcomes:
measure: Clinical Outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham & Women's Hospital, Harvard Medical School
name: Christopher M Bono, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Dana A Leonard, B.A.
role: STUDY_DIRECTOR
References: