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

Cervical Myelopathy Clinical Trial

Official title:

Are Rigid Cervical Collars Necessary for Patients Undergoing Open-door Laminoplasty and Titanium Arch Plates for Cervical Myelopathy? - A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400644
• Other study ID #: neck_collar1.0
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: February 28, 2018

Study information

• Verified date: February 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Myelopathy
• Spinal Cord Diseases

Intervention

Device:
• Cervical collar
Cervical neck collar which is routinely made for post-laminoplasty patients

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical spine range of motion (absolute values and changes from baseline, with standard deviations)	To be measured by a single operator using a goniometer	24 months
Primary	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	24 months
Primary	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	24 months
Primary	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	24 months
Primary	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	24 months
Primary	Spinal canal diameters at C3, C4, C5, C6	To measure any difference between 2 study groups at various time points	24 months
Secondary	Rate of recovery (in percentage)	to be derived from the JOA scores	24 months