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
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedNovember 15, 2022
November 1, 2022
1.8 years
March 6, 2020
November 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Neck pain intensity
numerical rating scale, 0 to 10 with higher scores indicating more severe pain
Through study duration to 12 weeks
Secondary Outcomes (9)
Neck Disability Index
Through study duration to 12 weeks
Arm pain intensity
Through study duration to 12 weeks
General health SF12
Through study duration to 12 weeks
Treatment satisfaction (% of patients satisfied)
Through study duration to 12 weeks
Time to meet discharge status (days)
day 2
- +4 more secondary outcomes
Study Arms (2)
Cervical Orthosis (CO)
ACTIVE COMPARATORCervical orthosis will be worn at all times for 6 weeks according the standard of care after posterior cervical fusion
No Orthosis (NO)
EXPERIMENTALNo cervical orthosis will be worn after posterior cervical fusion
Interventions
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.
Eligibility Criteria
You may qualify if:
- Undergoing multi-level (2- or more level), open, posterior cervical fusion which may extent into the second thoracic vertebrae (C1-T2)
- years of age and older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Related Publications (1)
Fernandes R, Thornley P, Urquhart J, Alahmari A, Alenezi N, Kelly S, Rasoulinejad P, Singh S, Siddiqi F, Gurr K, Bailey C. Cervical orthosis does not improve postoperative pain following posterior cervical fusion: a randomized controlled trial. Eur Spine J. 2024 Oct;33(10):4002-4011. doi: 10.1007/s00586-024-08456-7. Epub 2024 Aug 21.
PMID: 39167110DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris Bailey
London Health Science Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor and Staff Physician Department of Surgery, London Health Sciences Centre
Study Record Dates
First Submitted
March 6, 2020
First Posted
March 13, 2020
Study Start
October 1, 2020
Primary Completion
August 1, 2022
Study Completion
September 30, 2022
Last Updated
November 15, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share