Cervical RadiculopathyC-PASSNCT03842072
The Collar Post Anterior Cervical Spine Surgery Study
A study testing Cervical collar in people with Cervical Radiculopathy and Cervical Myelopathy, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Radiculopathy, Cervical Myelopathy
- What is being tested?
- Cervical collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Feb 2018to 1 Jul 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 18 and 80;
- presenting with cervical radiculopathy and/or myelopathy to one of the study centers;
- deemed appropriate by the attending surgeon involved for a one, two or three level plated ACDF or a one-level ACDF with a standalone interbody cage; and
- able to cooperate in the completion of all study consents, forms and documents. 5. Participants who are able to speak, read and write at an elementary school level
Who cannot join
- those with previous cervical surgery;
- those undergoing single or multi-level plated ACDF for a diagnosis related to malignancy, infection or trauma;
- those undergoing a single or multi-level plated ACDF augmented with a posterior cervical fusion or posterior cervical decompression and fusion;
- those undergoing a multi-level non-plated ACDF;
- those undergoing ACDF at greater than three levels, and;
- those with a pre-existent neurological or mental disorder which would preclude accurate evaluation and follow-up.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Hôpital Général de Montréal Montreal General Hospital
Montreal, Quebec, H3G 1A4
Francis Colagiacomo, B.A, 514.934.1934 ext. 45496
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Kayee Tung, RN
Jefferson R Wilson, MD, FRCSC
About this study
Official title: The Collar Post Anterior Cervical Spine Surgery (C-PASS) Study: Project Proposal for a Multi-Center Randomized Trial Evaluating the Impact of Post-Operative Bracing on Clinical Outcomes After Anterior Cervical Discectomy and Fusion.
The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position.
Our randomized trial comparing the impact of 6 weeks of post-operative bracing with a rigid cervical collar vs. no post-operative bracing, on a variety of clinical and radiological outcomes, for adult patients with cervical radiculopathy and/or myelopathy undergoing single or multi-level ACDF.
Read the detailed description
The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position.
- Conditions
- Cervical Radiculopathy, Cervical Myelopathy
- Being tested
- Cervical collar
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical collarDevice
cervical collars prescribed will be use immediately following anterior cervical discectomy and fusion surgery.
| Study group | Role | What they receive |
|---|---|---|
| No post-operative bracing | No intervention | patients in this arm will not be prescribed a cervical collar following anterior cervical discectomy and fusion surgery |
| Post-operative bracing | Active comparator | Patients in this arm will be prescribed a cervical collar following anterior cervical discectomy and fusion surgery. Receives: Device: Cervical collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability index
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
Measured: 6 month
Secondary outcomes (4)
Neck Disability Index
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
Measured: 3 and 12 month
EQ-5D
a standardized instrument for measuring generic health status.
Measured: 3, 6, 12 month
Visual analog score
a measurement instrument for pain where pain is measured from a score of 0 (represents no pain), and 10 (most pain, or worst pain imaginable.
Measured: 3, 6, 12 month
Plain Xray Radiography
An X-ray is a quick, painless test that produces images of the structures inside your body
Measured: 6 week, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start23 Feb 2018
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies 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
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jefferson Wilson, MD, FRCSC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842072
- Sponsor's protocol ID
- C-PASS
- Acronym
- C-PASS
- Status last verified
- Sep 2019
- First submitted
- 13 Feb 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Collar Post Anterior Cervical Spine Surgery (C-PASS) Study: Project Proposal for a Multi-Center Randomized Trial Evaluating the Impact of Post-Operative Bracing on Clinical Outcomes After Anterior Cervical Discectomy and Fusion.
- ClinicalTrials.gov ID
- NCT03842072
- Acronym / sponsor ID
- C-PASS / C-PASS
- Conditions
- Cervical Radiculopathy, Cervical Myelopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 15 Feb 2019 (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.
The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position.
Our randomized trial comparing the impact of 6 weeks of post-operative bracing with a rigid cervical collar vs. no post-operative bracing, on a variety of clinical and radiological outcomes, for adult patients with cervical radiculopathy and/or myelopathy undergoing single or multi-level ACDF.
Detailed description
The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No post-operative bracing | No intervention | –patients in this arm will not be prescribed a cervical collar following anterior cervical discectomy and fusion surgery |
| Post-operative bracing | Active comparator | Device: Cervical collarPatients in this arm will be prescribed a cervical collar following anterior cervical discectomy and fusion surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- between the ages of 18 and 80;
- presenting with cervical radiculopathy and/or myelopathy to one of the study centers;
- deemed appropriate by the attending surgeon involved for a one, two or three level plated ACDF or a one-level ACDF with a standalone interbody cage; and
- able to cooperate in the completion of all study consents, forms and documents. 5. Participants who are able to speak, read and write at an elementary school level
Key exclusion criteria (6 listed)
- those with previous cervical surgery;
- those undergoing single or multi-level plated ACDF for a diagnosis related to malignancy, infection or trauma;
- those undergoing a single or multi-level plated ACDF augmented with a posterior cervical fusion or posterior cervical decompression and fusion;
- those undergoing a multi-level non-plated ACDF;
- those undergoing ACDF at greater than three levels, and;
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 collarcervical collars prescribed will be use immediately following anterior cervical discectomy and fusion surgery. | Device | Post-operative bracing |
Primary outcome
Neck Disability index
Time frame: 6 month
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
4 secondary outcomes
Neck Disability Index
Time frame: 3 and 12 month
EQ-5D
Time frame: 3, 6, 12 month
Visual analog score
Time frame: 3, 6, 12 month
Plain Xray Radiography
Time frame: 6 week, 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- 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.
Jefferson Wilson, MD, FRCSC principal investigator
Unity Health Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical collar in people with Cervical Radiculopathy and Cervical Myelopathy, run by Unity Health Toronto at 2 sites 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kayee Tung (416.864.6060 ext. 2713, tungk@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability index (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.