Posterior Cervical Spinal SurgeryNCT04308122
Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion
A study testing Cervical Orthosis (CO) and No Orthosis in people with Posterior Cervical Spinal Surgery and Myelopathy Cervical, run by Dr. Christopher Bailey at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Cervical Spinal Surgery, Myelopathy Cervical, Radiculopathy, Cervical
- What is being tested?
- Cervical Orthosis (CO) and No Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Posterior Cervical Spinal Surgery, Myelopathy Cervical, Radiculopathy, Cervical, Spinal Stenosis Cervical, Spondylosis, Cervical
- Being tested
- Cervical Orthosis (CO), No Orthosis
- Medical subject headings
- Radiculopathy, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 OrthosisDevice
The NO group will have no specific precautions applied to their neck range of motion.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Orthosis (CO) | Active comparator | Cervical orthosis will be worn at all times for 6 weeks according the standard of care after posterior cervical fusion Receives: Device: Cervical Orthosis (CO) |
| No Orthosis (NO) | Experimental | No cervical orthosis will be worn after posterior cervical fusion Receives: Device: No Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain intensity
numerical rating scale, 0 to 10 with higher scores indicating more severe pain
Measured: Through study duration to 12 weeks
Secondary outcomes (9)
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.
Measured: Through study duration to 12 weeks
Arm pain intensity
numerical rating scale, 0 to 10 with higher scores indicating more severe pain
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Through study duration to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Oct 2020
- Primary completion1 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posterior Cervical Spinal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Christopher Bailey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Christopher Bailey, The London Spine Centre
- Investigators
- Chris Bailey, Principal investigator, London Health Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308122
- Sponsor's protocol ID
- 1.1 - 22-Apr-2020
- Status last verified
- Nov 2022
- First submitted
- 6 Mar 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39167110
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion
- ClinicalTrials.gov ID
- NCT04308122
- Acronym / sponsor ID
- 1.1 - 22-Apr-2020
- Conditions
- Posterior Cervical Spinal Surgery, Myelopathy Cervical, Radiculopathy, Cervical, Spinal Stenosis Cervical, Spondylosis, Cervical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dr. Christopher BaileyUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Orthosis (CO) | Active comparator | Device: Cervical Orthosis (CO)Cervical orthosis will be worn at all times for 6 weeks according the standard of care after posterior cervical fusion |
| No Orthosis (NO) | Experimental | Device: No OrthosisNo cervical orthosis will be worn after posterior cervical fusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Spinal cord injury
- Primary cervical spine infection
- Cervical spine tumor
- Inability to comprehend patient rated outcome instruments
- Substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Cervical Orthosis (CO) |
| No OrthosisThe NO group will have no specific precautions applied to their neck range of motion. | Device | No Orthosis (NO) |
Primary outcome
Neck pain intensity
Time frame: Through study duration to 12 weeks
numerical rating scale, 0 to 10 with higher scores indicating more severe pain
9 secondary outcomes
Neck Disability Index
Time frame: Through study duration to 12 weeks
Arm pain intensity
Time frame: Through study duration to 12 weeks
General health SF12
Time frame: Through study duration to 12 weeks
Treatment satisfaction (% of patients satisfied)
Time frame: Through study duration to 12 weeks
Time to meet discharge status (days)
Time frame: day 2
Adverse Events rate (%)
Time frame: Through study duration to 12 weeks
Pain medication usage
Time frame: Through study duration to 12 weeks
Range of motion
Time frame: Through study duration to 12 weeks
Compliance with wearing the collar (collar group only)
Time frame: Through study duration to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 39167110Fernandes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Bailey principal investigator
London Health Science Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Orthosis (CO) and No Orthosis in people with Posterior Cervical Spinal Surgery and Myelopathy Cervical, run by Dr. Christopher Bailey at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain intensity (time frame: Through study duration to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04308122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.