Recruiting

Smith-Robinson vs. Strap-Splitting

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT07533864

Conditions

Anterior Cervical Spine Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Anterior Cervical Spine Surgery

Study ID

NCT07533864

Start date

Apr, 2026

Status verified date

Apr, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Standard Smith-Robinson

Approach with incision between the strap muscles and the sternocleidomastoid

Strap-splitting

Approach with incision splitting the infrahyoid strap muscles

Primary outcome measure

  • Dysphagia as per the HSS-DDI [ Time Frame: 6 weeks post-operative ]

Central Contacts and Locations

Central contacts

Locations

Hamilton Health Sciences - Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L2X2

Contacts

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2026-04-29.