Clinical trial NCT04308122: Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion
Official title: A Randomized Trial of Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Cervical Spinal Surgery
Myelopathy Cervical
Radiculopathy, Cervical
Spinal Stenosis Cervical
Spondylosis, Cervical
Lead sponsor: The London Spine Centre
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Neck pain intensity
timeFrame: Through study duration to 12 weeks
Secondary outcomes:
measure: Neck Disability Index
timeFrame: Through study duration to 12 weeks
measure: Arm pain intensity
timeFrame: Through study duration to 12 weeks
measure: General health SF12
timeFrame: Through study duration to 12 weeks
measure: Treatment satisfaction (% of patients satisfied)
timeFrame: Through study duration to 12 weeks
measure: Time to meet discharge status (days)
timeFrame: day 2
measure: Adverse Events rate (%)
timeFrame: Through study duration to 12 weeks
measure: Pain medication usage
timeFrame: Through study duration to 12 weeks
measure: Range of motion
timeFrame: Through study duration to 12 weeks
measure: Compliance with wearing the collar (collar group only)
timeFrame: Through study duration to 12 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Science Centre
name: Chris Bailey
role: PRINCIPAL_INVESTIGATOR
References: