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

NCT03400644 | Completed

• 1 other identifier: neck_collar1.0
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Myelopathy

Keywords

open-door laminoplasty, laminoplasty, cervical collars

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• Spinal canal diameters at C3, C4, C5, C6

  To measure any difference between 2 study groups at various time points

  24 months

Secondary Outcomes (1)

• Rate of recovery (in percentage)

  24 months

Study Arms (2)

With Collar

ACTIVE COMPARATOR

Subjects are prescribed with custom-made rigid cervical collar which are to be worn for 3 weeks postoperatively

Device: Cervical collar

Without Collar

NO INTERVENTION

Subjects do not need to wear any cervical collar postoperatively

Interventions

Cervical collar DEVICE

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

With Collar

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Prospective, parallel single-blinded randomized controlled trial

Study Record Dates

• First Submitted: December 23, 2017
• First Posted: January 17, 2018
• Study Start: April 1, 2015
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2018
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

HK (1)