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Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion

Primary Purpose

Cervical Spondylosis Symptomatic Neurological Compression

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collar
No Collar
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spondylosis Symptomatic Neurological Compression focused on measuring cervical, laminectomy, fusion, neurological compression, spondylosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Brigham & Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Collar

No Collar

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fusion Rates
To compare the solid fusion rates between collar and no collar groups.

Secondary Outcome Measures

Clinical Outcomes
VAS and Neck Disability Index scores will be used to assess the clinical outcomes of both the collar and no collar groups.

Full Information

First Posted
June 27, 2011
Last Updated
October 21, 2013
Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01383876
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Enrollment too slow
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis Symptomatic Neurological Compression
Keywords
cervical, laminectomy, fusion, neurological compression, spondylosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collar
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Collar
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Collar
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No Collar
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fusion Rates
Description
To compare the solid fusion rates between collar and no collar groups.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Clinical Outcomes
Description
VAS and Neck Disability Index scores will be used to assess the clinical outcomes of both the collar and no collar groups.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M Bono, M.D.
Organizational Affiliation
Brigham & Women's Hospital, Harvard Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dana A Leonard, B.A.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion

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