Skip to content

ACSS Approach on Dysphagia

Anterior Cervical Spine Strap Muscle Splitting Versus Smith-Robinson Approach: A Single-Centre Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07533864
Enrollment
100
Registered
2026-04-16
Start date
2026-04-01
Completion date
2029-07-01
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cervical Spine Surgery

Keywords

anterior cervical spine surgery, dysphagia, Smith-Robinson, strap-splitting

Brief 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. 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.

Interventions

None listed

Sponsors

Hamilton Health Sciences Corporation
Lead SponsorOTHER
McMaster University
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Planned use of anterior odontoid screws * Revision anterior surgery * Trauma patient

Design outcomes

Primary

MeasureTime frameDescription
Dysphagia as per the HSS-DDI6 weeks post-operativeHospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms)

Secondary

MeasureTime frameDescription
Dysphagia as measured by the HSS-DDIpost-operative day 1, 6 months, and 12 monthsHospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms)
Changes in voice as measured by the HSS-DDIPost-operative day 1, 6 weeks, 6 months, and 12 monthsHospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms)
Length of intraoperative time in minutes, adjusting for surgeon, surgical type, and number of levelsTime of surgery
Injury to vital neurovascular structuresTime of surgery
Blood loss during surgery measured in mLTime of surgery

Countries

Canada

Contacts

CONTACTStudy Coordinator
martynia@mcmaster.ca950-521-2100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026