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

Dr. Christopher Bailey

Status: Completed

Conditions: Spondylosis, Cervical; Myelopathy Cervical; Radiculopathy, Cervical; Spinal Stenosis Cervical; Posterior Cervical Spinal Surgery

Treatments: Device: No Orthosis; Device: Cervical Orthosis (CO)

Study type: Interventional

Funder types: Other

Identifiers

NCT04308122

1.1 - 22-Apr-2020

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Cervical Orthosis (CO)

Active Comparator group

Description:

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

Treatment:

Device: Cervical Orthosis (CO)

No Orthosis (NO)

Experimental group

Description:

No cervical orthosis will be worn after posterior cervical fusion

Treatment:

Device: No Orthosis