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Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion

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ClinicalTrials.gov Identifier: NCT01383876
Recruitment Status : Terminated (Enrollment too slow)
First Posted : June 28, 2011
Last Update Posted : October 22, 2013
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Christopher Bono, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE June 27, 2011
First Posted Date  ICMJE June 28, 2011
Last Update Posted Date October 22, 2013
Study Start Date  ICMJE June 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2011)
Fusion Rates [ Time Frame: 1 year ]
To compare the solid fusion rates between collar and no collar groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01383876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2011)
Clinical Outcomes [ Time Frame: 1 year ]
VAS and Neck Disability Index scores will be used to assess the clinical outcomes of both the collar and no collar groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion
Official Title  ICMJE Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Cervical Spondylosis Symptomatic Neurological Compression
Intervention  ICMJE
  • 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.
Study Arms
  • 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.
    Intervention: Behavioral: Collar
  • 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.
    Intervention: Behavioral: No Collar
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 21, 2013)
11
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2011)
250
Actual Study Completion Date July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01383876
Other Study ID Numbers  ICMJE 2010P002931
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christopher Bono, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
Investigators  ICMJE
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
PRS Account Brigham and Women's Hospital
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP