Health TrialsbyHealthPanel

ACSS Approach on Dysphagia

ConditionAnterior Cervical Spine Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHamilton Health Sciences Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Planned use of anterior odontoid screws

Revision anterior surgery

Trauma patient

Trial population

Patients undergoing index anterior cervical spinal surgery (C2-C7)

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Standard Smith-Robinson
Group B: Strap-splitting

Trial outcomes

Primary outcomes

1

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)

Time frame
6 weeks post-operative

Secondary outcomes

1

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)

Time frame
post-operative day 1, 6 months, and 12 months
2

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)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hamilton Health Sciences Corporation

Lead sponsor

McMaster University

Collaborator

Source ClinicalTrials.gov
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