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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    40
  • sponsor
    Dr. Christopher Bailey
Updated on 3 May 2022
analgesics
aspen
neck pain
cervical fusion

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.

Details
Condition Posterior Cervical Spinal Surgery, Myelopathy Cervical, Radiculopathy, Cervical, Spinal Stenosis Cervical, Spondylosis, Cervical
Treatment No orthosis, Cervical Orthosis (CO)
Clinical Study IdentifierNCT04308122
SponsorDr. Christopher Bailey
Last Modified on3 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Undergoing multi-level (2- or more level), open, posterior cervical fusion which may extent into the second thoracic vertebrae (C1-T2)
Able to consent to inclusion in the study
18 years of age and older

Exclusion Criteria

Spinal cord injury
Primary cervical spine infection
Cervical spine tumor
Inability to comprehend patient rated outcome instruments
Substance abuse
Dementia
Psychosis
Previous surgery at same level
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