Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion

A Randomized Trial of Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion

Sponsors

Lead Sponsor: Dr. Christopher Bailey

Source The London Spine Centre
Brief Summary

Use of cervical orthosis after instrumented posterior cervical spinal surgery is still widely practiced even though modern fusion techniques likely do not require additional stabilization from an external orthosis. This is a single, centre randomized, non-blinded equivalence trial. Patients undergoing multi-level posterior cervical fusion will be randomized to cervical orthosis (CO group) or no orthosis (NO group). Immediately following surgery patients in the CO group will be fitted with a Philadelphia collar prior to being transferred to the recovery room. On the patient ward a physiotherapist will fit the patient with a Cervimax/Aspen/Miami J collar which will be worn at all times for 6 weeks according the standard of care. The NO group will have no specific precautions applied to their neck range of motion. Outcomes will be assessed prior to surgery, on the second day after surgery, and at 2, 4, 6 and 12 weeks after surgery. The primary outcome will be neck pain score on the numerical rating scale (ranging from 0-10 with higher scores indicating more severe pain) during the first 4 weeks after surgery with an equivalence margin of 2.0 points. Secondary outcomes will be neck disability, general health, treatment satisfaction, pain medication use, adverse events, neck range of motion, time meeting discharge status, and compliance in wearing the collar.

Overall Status Not yet recruiting
Start Date June 1, 2020
Completion Date July 31, 2023
Primary Completion Date May 31, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Neck pain intensity Through study duration to 12 weeks
Secondary Outcome
Measure Time Frame
Neck Disability Index Through study duration to 12 weeks
Arm pain intensity Through study duration to 12 weeks
General health SF12 Through study duration to 12 weeks
Treatment satisfaction (% of patients satisfied) Through study duration to 12 weeks
Time to meet discharge status (days) day 2
Adverse Events rate (%) Through study duration to 12 weeks
Pain medication usage Through study duration to 12 weeks
Range of motion Through study duration to 12 weeks
Compliance with wearing the collar (collar group only) Through study duration to 12 weeks
Enrollment 40
Condition
Intervention

Intervention Type: Device

Intervention Name: Cervical Orthosis (CO)

Description: Immediately following surgery patients in the CO group will be fitted with a Philadelphia collar prior to being transferred to the recovery room. On the patient ward a physiotherapist will fit the patient with a Cervimax/Aspen/Miami J collar which will be worn at all times for 6 weeks according the standard of care.

Arm Group Label: Cervical Orthosis (CO)

Intervention Type: Device

Intervention Name: No Orthosis

Description: The NO group will have no specific precautions applied to their neck range of motion.

Arm Group Label: No Orthosis (NO)

Eligibility

Criteria:

Inclusion Criteria:

1. Undergoing multi-level (2- or more level), open, posterior cervical fusion which may extent into the second thoracic vertebrae (C1-T2)

2. Able to consent to inclusion in the study

3. 18 years of age and older

Exclusion Criteria:

1. Spinal cord injury

2. Primary cervical spine infection

3. Cervical spine tumor

4. Inability to comprehend patient rated outcome instruments

5. Substance abuse

6. Dementia

7. Psychosis

8. Previous surgery at same level

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Chris Bailey Principal Investigator London Health Science Centre
Overall Contact

Last Name: Jennifer Urquhart

Phone: 5196858500

Email: [email protected]

Verification Date

May 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: The London Spine Centre

Investigator Full Name: Dr. Christopher Bailey

Investigator Title: Associate Professor and Staff Physician Department of Surgery, London Health Sciences Centre

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Cervical Orthosis (CO)

Type: Active Comparator

Description: Cervical orthosis will be worn at all times for 6 weeks according the standard of care after posterior cervical fusion

Label: No Orthosis (NO)

Type: Experimental

Description: No cervical orthosis will be worn after posterior cervical fusion

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov