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

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ClinicalTrials.gov Identifier: NCT04308122
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Christopher Bailey, The London Spine Centre

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.

Condition or disease Intervention/treatment Phase
Posterior Cervical Spinal Surgery Myelopathy Cervical Radiculopathy, Cervical Spinal Stenosis Cervical Spondylosis, Cervical Device: Cervical Orthosis (CO) Device: No Orthosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Active Comparator: Cervical Orthosis (CO)
Cervical orthosis will be worn at all times for 6 weeks according the standard of care after posterior cervical fusion
Device: 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.

Experimental: No Orthosis (NO)
No cervical orthosis will be worn after posterior cervical fusion
Device: No Orthosis
The NO group will have no specific precautions applied to their neck range of motion.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308122


Contacts
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Contact: Jennifer Urquhart 5196858500 Jennifer.Urquhart@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Jennifer Urquhart    519-685-8500 ext 53062    jennifer.urquhart@lhsc.on.ca   
Sponsors and Collaborators
Dr. Christopher Bailey
Investigators
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Principal Investigator: Chris Bailey London Health Science Centre
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Responsible Party: Dr. Christopher Bailey, Associate Professor and Staff Physician Department of Surgery, London Health Sciences Centre, The London Spine Centre
ClinicalTrials.gov Identifier: NCT04308122    
Other Study ID Numbers: 1.1 - 22-Apr-2020
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spinal Stenosis
Spondylosis
Radiculopathy
Spinal Cord Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Central Nervous System Diseases