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

A Randomized Trial of 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.

Study Overview

• Status: Completed
• Conditions: Myelopathy Cervical; Radiculopathy, Cervical; Spinal Stenosis Cervical; Posterior Cervical Spinal Surgery; Spondylosis, Cervical
• Intervention / Treatment: Device: Cervical Orthosis (CO); Device: No Orthosis

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck pain intensity	numerical rating scale, 0 to 10 with higher scores indicating more severe pain	Through study duration to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index	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.	Through study duration to 12 weeks
Arm pain intensity	numerical rating scale, 0 to 10 with higher scores indicating more severe pain	Through study duration to 12 weeks
General health SF12	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.	Through study duration to 12 weeks
Treatment satisfaction (% of patients satisfied)	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.	Through study duration to 12 weeks
Time to meet discharge status (days)	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	day 2
Adverse Events rate (%)	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.	Through study duration to 12 weeks
Pain medication usage	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.	Through study duration to 12 weeks
Range of motion	Change in cobb angle in flexion-extension xrays and a goniometer to measure flexion-extension and rotation	Through study duration to 12 weeks
Compliance with wearing the collar (collar group only)	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.	Through study duration to 12 weeks

Collaborators and Investigators

• Sponsor: Dr. Christopher Bailey
• Investigators: Principal Investigator: Chris Bailey, London Health Science Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Radiculopathy; Spinal Cord Diseases; Spinal Stenosis; Spondylosis
• Other Study ID Numbers: 1.1 - 22-Apr-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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