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NCT Number: NCT04308122

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

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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Key information

Conditions

Posterior Cervical Spinal Surgery Bone Diseases Musculoskeletal Diseases Myelopathy Cervical Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy Radiculopathy, Cervical Spinal Diseases Spinal Stenosis Cervical Spondylosis Spondylosis, Cervical

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical Orthosis (CO)

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

Device

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

Primary outcomes

  1. Neck pain intensity

    Time frame: Through study duration to 12 weeks

    numerical rating scale, 0 to 10 with higher scores indicating more severe pain

Secondary outcomes

  1. Neck Disability Index

    Time frame: Through study duration to 12 weeks

    NDI is a self-administered questionnaire with 10 questions. Each question is scored from 0 to 5 for a maximum score of 50 and the score converted to a percentage score. The scale ranges from 0 to 100 with a higher score denoting worse disability.

  2. Arm pain intensity

    Time frame: Through study duration to 12 weeks

    numerical rating scale, 0 to 10 with higher scores indicating more severe pain

  3. General health SF12

    Time frame: Through study duration to 12 weeks

    is a generic, multidimensional self-report health questionnaireQuestions are categorized into scales for general health, physical functioning, social functioning, role limitation-physical, role limitation-emotional, mental health, energy/fatigue, pain, comparative health. These are summarized into the SF12-physical component summary score (PCS) and mental component summary score (MCS). Scores range from 0 to 100 with higher scores impling better functioning.

  4. Treatment satisfaction (% of patients satisfied)

    Time frame: Through study duration to 12 weeks

    Treatment satisfaction will be assessed by the following question: "Are you satisfied with the results of your spine surgery?" using a 5-category scale as follows: 1) extremely satisfied, 2) somewhat satisfied, 3) Neither satisfied nor dissatisfied, 4) somewhat dissatisfied, 5) extremely dissatisfied.

  5. Time to meet discharge status (days)

    Time frame: day 2

    measured as the number of days it takes to meet all discharge criteria including:

    • Ambulating safely and independently as assessed by the physiotherapist
    • Pain controlled with oral analgesics
    • Minimal wound drainage following drain removal
    • For the CO group only: proficient donning and doffing the CO as assessed by physiotherapy/occupation therapy

  6. Adverse Events rate (%)

    Time frame: Through study duration to 12 weeks

    The Spinal Adverse Events Severity Grading System (SAVES) form will be used to capture intra-operative, peri-operative, and post-operative adverse events and serious adverse events.

  7. Pain medication usage

    Time frame: Through study duration to 12 weeks

    The total dosage of opioids and NSAID for the hospital length of stay will be calculated. The type of medication used (over the counter, NSAID, muscle relaxant, narcotics, anti-depressant, neuroeleptic and other) will be indicated as not taken, as needed, and daily at week 2, 4, 6, and 12 after surgery.

  8. Range of motion

    Time frame: Through study duration to 12 weeks

    Change in cobb angle in flexion-extension xrays and a goniometer to measure flexion-extension and rotation

  9. Compliance with wearing the collar (collar group only)

    Time frame: Through study duration to 12 weeks

    Patients will be asked they used the collar as prescribed. If not, they will be asked if they wore the collar at all, and if yes for how many hours per day. Compliance will be defined as prescribed, irregular or aborted. Patients will be compliant if they wear the collar for> 20 hours per day.

Sponsors and collaborators

Lead sponsor

Dr. Christopher Bailey

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2020
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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