Anterior Cervical Spine SurgeryNCT07533864
ACSS Approach on Dysphagia
An observational study of Anterior Cervical Spine Surgery, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Anterior cervical spine surgery (ACSS) is a procedure for the treatment of several neck problems. Even though the procedure is overall safe and effective, there are possible complications after surgery, which include problems swallowing, hoarseness of the voice, and pain when swallowing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cervical Spine Surgery
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2026to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients undergoing index anterior cervical spinal surgery (C2-C7)
Who may be able to join
- Adult patients (18 years of age or older).
- Patients undergoing anterior cervical spine surgery including Anterior cervical discectomy and fusion (ACDF), Anterior cervical arthroplasty (ACA) and Anterior cervical corpectomy and fusion (ACCF)
- Ability to complete HSS-DDI questionnaire in English
Who cannot join
- Planned use of anterior odontoid screws
- Revision anterior surgery
- Trauma patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences - Hamilton General Hospital
Hamilton, Ontario, L8L2X2
Study Coordinator, 905-521-2100 ext. 44155, martynia@mcmaster.ca
About this study
Official title: Anterior Cervical Spine Strap Muscle Splitting Versus Smith-Robinson Approach: A Single-Centre Observational Study
Anterior cervical spine surgery (ACSS) is a procedure for the treatment of several neck problems. Even though the procedure is overall safe and effective, there are possible complications after surgery, which include problems swallowing, hoarseness of the voice, and pain when swallowing.
There are two different ways the spinal surgeon can approach the spine from the front of the neck. One is called a Smith-Robinson approach, and the other is called a strap-splitting approach. Each approach uses the same skin cut, the difference is only in how the next layer is approached, whether on the outside (Smith-Robinson) or through (strap-splitting) one of the small muscles in your neck. Because of the slightly different approaches to the surgery, we want to see if there are differences in complications related to swallowing and speaking between these two approaches.
Participants will undergo one of the two surgical approaches, based on surgeon preference. Participants will complete a questionnaire at several time points during their clinical follow-up to assess any difficulties swallowing and speaking.
- Conditions
- Anterior Cervical Spine Surgery
- Keywords
- anterior cervical spine surgery, dysphagia, Smith-Robinson, strap-splitting
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard Smith-Robinson | Approach with incision between the strap muscles and the sternocleidomastoid | |
| Strap-splitting | Approach with incision splitting the infrahyoid strap muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia as per the HSS-DDI
Hospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms)
Measured: 6 weeks post-operative
Secondary outcomes (5)
Dysphagia as measured by the HSS-DDI
Hospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms)
Measured: post-operative day 1, 6 months, and 12 months
Changes in voice as measured by the HSS-DDI
Hospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms)
Measured: Post-operative day 1, 6 weeks, 6 months, and 12 months
Length of intraoperative time in minutes, adjusting for surgeon, surgical type, and number of levels
Measured: Time of surgery
Injury to vital neurovascular structures
Measured: Time of surgery
Blood loss during surgery measured in mL
Measured: Time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cervical Spine 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533864
- Sponsor's protocol ID
- 17392
- Status last verified
- Sep 2026
- First submitted
- 9 Apr 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cervical Spine Strap Muscle Splitting Versus Smith-Robinson Approach: A Single-Centre Observational Study
- ClinicalTrials.gov ID
- NCT07533864
- Acronym / sponsor ID
- 17392
- Conditions
- Anterior Cervical Spine Surgery
- Keywords
- anterior cervical spine surgery, dysphagia, Smith-Robinson, strap-splitting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 16 Apr 2026 (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.
Anterior cervical spine surgery (ACSS) is a procedure for the treatment of several neck problems. Even though the procedure is overall safe and effective, there are possible complications after surgery, which include problems swallowing, hoarseness of the voice, and pain when swallowing.
There are two different ways the spinal surgeon can approach the spine from the front of the neck. One is called a Smith-Robinson approach, and the other is called a strap-splitting approach. Each approach uses the same skin cut, the difference is only in how the next layer is approached, whether on the outside (Smith-Robinson) or through (strap-splitting) one of the small muscles in your neck. Because of the slightly different approaches to the surgery, we want to see if there are differences in complications related to swallowing and speaking between these two approaches.
Participants will undergo one of the two surgical approaches, based on surgeon preference. Participants will complete a questionnaire at several time points during their clinical follow-up to assess any difficulties swallowing and speaking.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Smith-Robinson | – | –Approach with incision between the strap muscles and the sternocleidomastoid |
| Strap-splitting | – | –Approach with incision splitting the infrahyoid strap muscles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing index anterior cervical spinal surgery (C2-C7)
Key inclusion criteria (3 listed)
- Adult patients (18 years of age or older).
- Patients undergoing anterior cervical spine surgery including Anterior cervical discectomy and fusion (ACDF), Anterior cervical arthroplasty (ACA) and Anterior cervical corpectomy and fusion (ACCF)
- Ability to complete HSS-DDI questionnaire in English
Key exclusion criteria (3 listed)
- Planned use of anterior odontoid screws
- Revision anterior surgery
- Trauma patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dysphagia as per the HSS-DDI
Time frame: 6 weeks post-operative
Hospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms)
5 secondary outcomes
Dysphagia as measured by the HSS-DDI
Time frame: post-operative day 1, 6 months, and 12 months
Changes in voice as measured by the HSS-DDI
Time frame: Post-operative day 1, 6 weeks, 6 months, and 12 months
Length of intraoperative time in minutes, adjusting for surgeon, surgical type, and number of levels
Time frame: Time of surgery
Injury to vital neurovascular structures
Time frame: Time of surgery
Blood loss during surgery measured in mL
Time frame: Time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Function After Anterior Cervical Discectomy and Fusion Surgery: Timing of Physical Therapy
Cervical Spine Degeneration, ACDF Surgery
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Cervical Movement Control Before and After Anterior Cervical Discectomy and Fusion
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cervical Spine Surgery, run by Hamilton Health Sciences Corporation 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 3 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (950-521-2100 ext. 44155, martynia@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia as per the HSS-DDI (time frame: 6 weeks post-operative). 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 30 Sep 2026.