Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion

This study has been terminated.
(Enrollment too slow)
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Christopher Bono, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01383876
First received: June 27, 2011
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Cervical Spondylosis Symptomatic Neurological Compression
Behavioral: Collar
Behavioral: No Collar

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion: A Randomized Controlled Trial

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Fusion Rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To compare the solid fusion rates between collar and no collar groups.


Secondary Outcome Measures:
  • Clinical Outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    VAS and Neck Disability Index scores will be used to assess the clinical outcomes of both the collar and no collar groups.


Enrollment: 11
Study Start Date: June 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383876

Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Brigham and Women's Hospital
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
  More Information

No publications provided

Responsible Party: Christopher Bono, Christopher M. Bono, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01383876     History of Changes
Other Study ID Numbers: 2010P002931
Study First Received: June 27, 2011
Last Updated: October 21, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
cervical
laminectomy
fusion
neurological compression
spondylosis

Additional relevant MeSH terms:
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 22, 2014