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Are Rigid Cervical Collars Necessary for Open-door Laminoplasty and Titanium Arch Plates for Cervical Myelopathy?

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ClinicalTrials.gov Identifier: NCT03400644
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Jason Pui Yin Cheung, The University of Hong Kong

Brief Summary:
This is a randomized controlled trial to assess the use of rigid neck collar postoperatively. It consists of patients with cervical myelopathy undergoing open-door laminoplasty with titanium arch plates. Patients are divided into two groups: one group are not using rigid neck collar whereas the second group of patients wear rigid neck collar for three weeks postoperatively. Both groups of patients will then be assessed at fixed intervals. Clinical assessments include the cervical spine range of motion, any axial neck pain and also a full neurological examination. Radiographs will be used to assess for any complications. Cervical spine alignment and relevant questionnaires will be done and recorded. These results will help to conclude whether we can avoid the use of rigid cervical collars postoperatively, in view of the associated problems arising from restricted neck movement.

Condition or disease Intervention/treatment Phase
Cervical Myelopathy Device: Cervical collar Not Applicable

Detailed Description:
Current management protocols regarding cervical laminoplasty is to provide early immobilization with rigid cervical neck collars to avoid implant failure, loss of correction and recurrence of neurological deficit. However, there is no strong evidence supporting the need for neck collars in laminoplasty especially since modern plating fixation methods are already very rigid. Cervical neck collars should also not be used haphazardly due to possible complications and cost implications. Cervical range of motion has been shown to reduce with rigid cervical collars. Decreased voluntary eye movement and postural stability has also been illustrated. Longer duration of neck collar use may even lead to postoperative axial neck pain. Neck collars has also been linked to complications such as pressure ulcers, nerve palsy, skin reactions, dysphagia and respiratory problems. The costs of collar manufacturing and maintenance is not small and must also be taken into consideration. With stronger fixation devices like plates, the above complications can be avoided. Most clinicians still use neck collars for protection mainly due to historical reasons. However this is not an evidence-based approach. By eliminating the need for neck collars, patients are allowed earlier mobilization, less neck stiffness and axial neck pain while reducing its cost. Hence this study is important to provide a basis for changing clinical practice. The study is a prospective randomized controlled trial. Patients are consecutively and randomly divided into two groups . One group of patients will receive no cervical collar postoperatively and a second group will receive rigid neck collar for 3 weeks postoperatively. Operative techniques will be standardized. All assessments are performed 3 and 6 weeks, and 3, 6, 12 and 24 months postoperatively. The subjects were analysed in terms of clinical and functional outcomes through radiographic measurements, clinical assessment and questionnaires.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, parallel single-blinded randomized controlled trial
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Are Rigid Cervical Collars Necessary for Patients Undergoing Open-door Laminoplasty and Titanium Arch Plates for Cervical Myelopathy? - A Randomized Clinical Trial
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: With Collar
Subjects are prescribed with custom-made rigid cervical collar which are to be worn for 3 weeks postoperatively
Device: Cervical collar
Cervical neck collar which is routinely made for post-laminoplasty patients

No Intervention: Without Collar
Subjects do not need to wear any cervical collar postoperatively



Primary Outcome Measures :
  1. Cervical spine range of motion (absolute values and changes from baseline, with standard deviations) [ Time Frame: 24 months ]
    To be measured by a single operator using a goniometer

  2. Axial neck pain (absolute values and changes from baseline, with standard deviations) [ Time Frame: 24 months ]
    Patient is asked to rate their axial neck pain on the day of follow-up, with the VAS scale 0-10 with 0 being the least and 10 being the worst pain experienced

  3. SF-36 (absolute values and changes from baseline, with standard deviations) [ Time Frame: 24 months ]
    As a utility score and for assessing any difference between the cervical collar versus the without cervical collar group. The physical health component and mental health component are derived from the following subscales: Physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality, mental health, social functioning, bodily pain and general health perception

  4. JOA scores (absolute values and changes from baseline, with standard deviations) [ Time Frame: 24 months ]
    JOA consists of 6 domain scores and allow assessment as a composite scores or from individual domain: motor dysfunction in the upper and lower extremities; sensory function in the upper and lower extremities and in the trunk; and the bladder function

  5. Neck Disability Index (absolute values and changes from baseline, with standard deviations) [ Time Frame: 24 months ]
    An outcome score in assessing how neck pain affecting subjects' daily life activities

  6. Spinal canal diameters at C3, C4, C5, C6 [ Time Frame: 24 months ]
    To measure any difference between 2 study groups at various time points


Secondary Outcome Measures :
  1. Rate of recovery (in percentage) [ Time Frame: 24 months ]
    to be derived from the JOA scores



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients attending either Queen Mary Hospital or Duchess of Kent Children's Hospital, who are over 18 years of age, and present with clinical and radiological signs compatible with cervical myelopathy undergoing laminoplasty. Patients must be literate and able to comprehend the study to be enrolled.

Exclusion Criteria:

  • All patients with previous cervical spine surgery, congenital deformities, spine infection or inflammation, tumour, fusion surgery, non-Chinese, undergoing workman's compensation and unable or refuse to follow the standardized rehabilitation protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400644


Locations
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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong

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Responsible Party: Dr. Jason Pui Yin Cheung, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03400644     History of Changes
Other Study ID Numbers: neck_collar1.0
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Jason Pui Yin Cheung, The University of Hong Kong:
open-door laminoplasty, laminoplasty, cervical collars

Additional relevant MeSH terms:
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Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases