Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion

Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion: A Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Cervical Spondylosis Symptomatic Neurological Compression
• Intervention / Treatment: Behavioral: Collar; Behavioral: No Collar

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Collar; 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: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion Rates	To compare the solid fusion rates between collar and no collar groups.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcomes	VAS and Neck Disability Index scores will be used to assess the clinical outcomes of both the collar and no collar groups.	1 year

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts General Hospital; Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Christopher M Bono, M.D., Brigham & Women's Hospital, Harvard Medical School; Study Director: Dana A Leonard, B.A., Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: June 27, 2011
• First Posted (Estimate): June 28, 2011

Study Record Updates

• Last Update Posted (Estimate): October 22, 2013
• Last Update Submitted That Met QC Criteria: October 21, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: fusion; cervical; laminectomy; spondylosis; neurological compression
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylosis
• Other Study ID Numbers: 2010P002931