- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03400644
Are Rigid Cervical Collars Necessary for Open-door Laminoplasty and Titanium Arch Plates for Cervical Myelopathy?
February 9, 2019 updated by: Dr. Jason Pui Yin Cheung, The University of Hong Kong
Are Rigid Cervical Collars Necessary for Patients Undergoing Open-door Laminoplasty and Titanium Arch Plates for Cervical Myelopathy? - A Randomized Clinical Trial
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- Queen Mary Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months
|
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
|
24 months
|
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
|
24 months
|
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
|
24 months
|
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
|
24 months
|
Spinal canal diameters at C3, C4, C5, C6
Time Frame: 24 months
|
To measure any difference between 2 study groups at various time points
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of recovery (in percentage)
Time Frame: 24 months
|
to be derived from the JOA scores
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
February 28, 2017
Study Completion (Actual)
February 28, 2018
Study Registration Dates
First Submitted
December 23, 2017
First Submitted That Met QC Criteria
January 13, 2018
First Posted (Actual)
January 17, 2018
Study Record Updates
Last Update Posted (Actual)
February 12, 2019
Last Update Submitted That Met QC Criteria
February 9, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- neck_collar1.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Myelopathy
-
Valérie SchuermansRecruitingCervical Disc Disease | Cervical Fusion | Fusion of Spine | Cervical Spondylosis | Cervical Disc Herniation | Myelopathy Cervical | Cervical Disc Degeneration | Radiculopathy, Cervical | Myelopathy, Compressive | Radiculopathy, Cervical Region | Radiculopathy; in Spondylosis | Radiculopathy; in Intervertebral... and other conditionsNetherlands
-
Cambridge University Hospitals NHS Foundation TrustNational Institute for Health Research, United Kingdom; Wolfson Brain Imaging...RecruitingCervical Spondylosis With Myelopathy | Degenerative Cervical MyelopathyUnited Kingdom
-
Peking University Third HospitalCompleted
-
National Taiwan University HospitalCompletedCervical Radiculopathy | Cervical MyelopathyTaiwan
-
Unity Health TorontoUnknownCervical Radiculopathy | Cervical MyelopathyCanada
-
Shanghai Changzheng HospitalRecruitingMyelopathy CervicalChina
-
University of KentuckyRecruiting
-
Imperial College Healthcare NHS TrustNot yet recruitingCervical Myelopathy
-
University of UtahEnrolling by invitationCervical MyelopathyUnited States
-
The University of Hong KongCompleted
Clinical Trials on Cervical collar
-
Oslo University HospitalTerminatedCollar Treatment of Stable Subaxial Spine FracturesNorway
-
More FoundationDJO LLCCompletedCervical PainUnited States
-
Unity Health TorontoUnknownCervical Radiculopathy | Cervical MyelopathyCanada
-
Hadassah Medical OrganizationCompletedElective Surgical ProcedureIsrael
-
Medical Center HaaglandenCompleted
-
Uppsala UniversityActive, not recruiting
-
Tanta UniversityUnknownOptic Nerve Sheath Diameter | Point of Care UltrasoundEgypt
-
Ullevaal University HospitalNorwegian Fund for Postgraduate Training in PhysiotherapyCompleted
-
Taipei Veterans General Hospital, TaiwanCompleted
-
Johns Hopkins UniversityRecruiting