Cervical MyelopathyNCT03400644
Are Rigid Cervical Collars Necessary for Open-door Laminoplasty and Titanium Arch Plates for Cervical Myelopathy?
A study testing Cervical collar in people with Cervical Myelopathy, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Myelopathy
- What is being tested?
- Cervical collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2015to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Myelopathy
- Being tested
- Cervical collar
- Keywords
- open-door laminoplasty, laminoplasty, cervical collars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical collarDevice
Cervical neck collar which is routinely made for post-laminoplasty patients
| Study group | Role | What they receive |
|---|---|---|
| With Collar | Active comparator | Subjects are prescribed with custom-made rigid cervical collar which are to be worn for 3 weeks postoperatively Receives: Device: Cervical collar |
| Without Collar | No intervention | Subjects do not need to wear any cervical collar postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical spine range of motion (absolute values and changes from baseline, with standard deviations)
To be measured by a single operator using a goniometer
Measured: 24 months
Axial neck pain (absolute values and changes from baseline, with standard deviations)
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
Measured: 24 months
SF-36 (absolute values and changes from baseline, with standard deviations)
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
Measured: 24 months
JOA scores (absolute values and changes from baseline, with standard deviations)
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
Measured: 24 months
Neck Disability Index (absolute values and changes from baseline, with standard deviations)
An outcome score in assessing how neck pain affecting subjects' daily life activities
Measured: 24 months
Spinal canal diameters at C3, C4, C5, C6
To measure any difference between 2 study groups at various time points
Measured: 24 months
Secondary outcomes (1)
Rate of recovery (in percentage)
to be derived from the JOA scores
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Apr 2015
- Primary completion28 Feb 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel single-blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jason Pui Yin Cheung, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400644
- Sponsor's protocol ID
- neck_collar1.0
- Status last verified
- Feb 2019
- First submitted
- 23 Dec 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Rigid Cervical Collars Necessary for Patients Undergoing Open-door Laminoplasty and Titanium Arch Plates for Cervical Myelopathy? - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03400644
- Acronym / sponsor ID
- neck_collar1.0
- Conditions
- Cervical Myelopathy
- Keywords
- open-door laminoplasty, laminoplasty, cervical collars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, parallel single-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| With Collar | Active comparator | Device: Cervical collarSubjects are prescribed with custom-made rigid cervical collar which are to be worn for 3 weeks postoperatively |
| Without Collar | No intervention | –Subjects do not need to wear any cervical collar postoperatively |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical collarCervical neck collar which is routinely made for post-laminoplasty patients | Device | With Collar |
Primary outcome
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
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
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
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
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
Spinal canal diameters at C3, C4, C5, C6
Time frame: 24 months
To measure any difference between 2 study groups at various time points
1 secondary outcome
Rate of recovery (in percentage)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical collar in people with Cervical Myelopathy, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical spine range of motion (absolute values and changes from baseline, with standard deviations) (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.