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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Posterior Cervical Spinal Surgery Myelopathy Cervical Radiculopathy, Cervical Spinal Stenosis Cervical Spondylosis, Cervical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cervical Orthosis (CO)

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

Group Type ACTIVE_COMPARATOR

Cervical Orthosis (CO)

Intervention Type DEVICE

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.

No Orthosis (NO)

No cervical orthosis will be worn after posterior cervical fusion

Group Type EXPERIMENTAL

No Orthosis

Intervention Type DEVICE

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

Interventions

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Cervical Orthosis (CO)

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.

Intervention Type DEVICE

No Orthosis

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No