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NCT Number: NCT07533864

ACSS Approach on Dysphagia

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location status: Recruiting

Location contact

Study Coordinator

CONTACT

[email protected]

905-521-2100 ext. 44155

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Dysphagia as measured by the HSS-DDI

    Time frame: post-operative day 1, 6 months, and 12 months

    Hospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms)

  2. Changes in voice as measured by the HSS-DDI

    Time frame: Post-operative day 1, 6 weeks, 6 months, and 12 months

    Hospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms)

  3. Length of intraoperative time in minutes, adjusting for surgeon, surgical type, and number of levels

    Time frame: Time of surgery

  4. Injury to vital neurovascular structures

    Time frame: Time of surgery

  5. Blood loss during surgery measured in mL

    Time frame: Time of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

950-521-2100 ext. 44155

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • McMaster University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 16, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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