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

NCT ID: NCT03400644

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2018-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

With Collar

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

Group Type: ACTIVE_COMPARATOR

Cervical collar

Intervention Type: DEVICE

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

Without Collar

Subjects do not need to wear any cervical collar postoperatively

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cervical collar

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

Intervention Type: DEVICE

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Jason Pui Yin Cheung

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

neck_collar1.0

Identifier Type: -

Identifier Source: org_study_id