Cervical Disc Herniation, Cervical Degenerative Disc Disease, Cervical Spondylotic Myelopathy, Dysphagia, Osteoarthritis of Cervical Spine
Conditions
Keywords
Anterior Cervical Discectomy and Fusion, Dysphagia, ACDF
Brief summary
The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.
Detailed description
Background: Dysphagia is a serious post-operative concern in patients following anterior cervical surgery. Although many experts have acknowledged that dysphagia is often incompletely understood and defined, there is a significant amount of literature to support the significance of this clinical entity. This is the first randomized study to examine the use of topical steroids for the prevention of dysphagia postoperatively after anterior cervical discectomy and fusion. Study Design: This study is a single site, double blinded randomized control trial. All individuals undergoing 2-4 level ACDF that meet the inclusion criteria will be randomized to either: 1. treatment arm or 2. control arm. Both arms will undergo their planned surgeries and will receive the exact same procedure and standard of care as if they were not enrolled in a study. The only difference is that the treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with one Hemostatic Matrix Kit injectable delivery vehicle prior to closure in the prevertebral soft tissues. The control group will receive only Hemostatic Matrix Kit prior to closure in the prevertebral soft tissues. Outcomes: Patients will be asked to fill out questionnaires that assess dysphagia, general swallowing difficulty, and how neck pain impacts their quality of life. Additionally Radiographic images will be obtained at set time points to evaluate soft tissue inflammation and bony fusion.
Interventions
Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.
OTHERHemostatic Matrix Kit
Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient \> 18 years undergoing a 2-4 level Anterior Cervical Discectomy and Fusion
Exclusion criteria
* Patients undergoing revision surgery * Pediatric patients * Trauma patients with cervical spine fractures * Patients with cancer * Patients with active infection * Patients with a known allergy to Methylprednisolone Acetate * Patients who refuse to participate * Non English speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Dysphagia Patients Experience (Fatigue) | Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best) |
| Degree of Dysphagia Patients Experience (Burden) | Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best) |
| Degree of Dysphagia Patients Experience (Eating Desire) | Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best) |
| Degree of Dysphagia Patients Experience (Eating Duration) | Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best) |
| Degree of Dysphagia Patients Experience (Food Selection) | Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best) |
| Degree of Dysphagia Patients Experience (Communication) | Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best) |
| Degree of Dysphagia Patients Experience (Fear Swallow) | Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best) |
| Degree of Dysphagia Patients Experience (Social) | Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best) |
| Degree of Dysphagia Patients Experience (Mental) | Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best) |
| Degree of Dysphagia Patients Experience (Sleep) | Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Swallowing Difficulty Over 1 Year | Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | The Eating Assessment Tool (EAT-10) is used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of OD. Modified Eat-10 : Eat-10 questionnaire without questions 1 (My swallowing problem has caused me to lose weight) and 2 (My swallowing problem interferes with my ability to go out for meals) to be applicable during hospitalization. Eat-10 interpretation: Score ranging from 0 to 40 (best-worst) * each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response Modified EAT-10 interpretation: Score ranging from 0 to 32 (best-worst) * each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response |
| Patients' Bazaz Dysphagia Score - Liquid | Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods. |
| Patients' Bazaz Dysphagia Score - Solid | Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods. |
| Patients' Neck Disability | Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months | Neck Disability Index (NDI) Range from 0 to 100 (best-worst) |
| Patients' Pain Scores on the Visual Analog Scale - Neck Pain | Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst) |
| Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst) |
| Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months | Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst) |
| Change in Pre-vertebral Soft Tissue Swelling Over 1 Year | Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months | We are unable to report this outcome measure because soft tissue swelling was not assessed. The PI deemed it would not be included for this study as there is not a clinical or research standard to do so, nor is there normative data over time to compare against. Thus, data were not collected. |
| Fusion Rate | 12 Months | 1. Flex-Ex X-rays 2. Bony bridging on a CT scan 3. Obvious bony remodeling on lateral X-ray |
| Adverse Event | 12 month | Adverse Event (AE) following surgical treatment. Adverse event were classified by severity based on the AO-ISSG criteria and treatment required: Mild: Observed, medication, consult, X-ray. Essentially any management that was quick and easy and could be done at bedside Moderate: ICU admission, re-intubation, complication that had a documented prolonged hospital stay, medical procedure (such as flexible endoscopy), re-presentation to ED Severe: Inpatient re-admission, return to OR for any reason, mortality, failed OR. AE were also categorize as Surgery-site related or unrelated adverse event. Finally, AE were also categorize as potentially related to steroid use (example: leukocytosis, pseudoarthrosis, or wound complications) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.
Methylprednisolone Acetate: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.
Hemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure. | 56 |
| Control Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.
Hemostatic Matrix Kit: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure. | 53 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete dataset | 6 | 6 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 3 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 10.5 | 58.4 years STANDARD_DEVIATION 11.5 | 58.2 years STANDARD_DEVIATION 11 |
| Charlson Comorbidities Index (CCI) | 2 index | 2 index | 2 index |
| Diagnosis Cervical disk disorder | 1 Participants | 0 Participants | 1 Participants |
| Diagnosis Disk degrative disease | 2 Participants | 5 Participants | 7 Participants |
| Diagnosis Foraminal Stenosis | 1 Participants | 6 Participants | 7 Participants |
| Diagnosis Herniated disc | 8 Participants | 4 Participants | 12 Participants |
| Diagnosis Myelopathy | 14 Participants | 14 Participants | 28 Participants |
| Diagnosis Myeloradiculopathy | 15 Participants | 17 Participants | 32 Participants |
| Diagnosis Osteoarthritis of the Cervical Spine | 0 Participants | 1 Participants | 1 Participants |
| Diagnosis Radiculopathy | 31 Participants | 23 Participants | 54 Participants |
| Diagnosis Spondylosis | 39 Participants | 32 Participants | 71 Participants |
| Diagnosis Stenosis | 10 Participants | 10 Participants | 20 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 56 participants | 53 participants | 109 participants |
| Sex: Female, Male Female | 29 Participants | 24 Participants | 53 Participants |
| Sex: Female, Male Male | 27 Participants | 29 Participants | 56 Participants |
| Smoking status Current (within the last 30 days) | 6 Participants | 4 Participants | 10 Participants |
| Smoking status Former (quit > 30 days) | 23 Participants | 14 Participants | 37 Participants |
| Smoking status Not Applicable | 27 Participants | 35 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 56 |
| other Total, other adverse events | 42 / 53 | 46 / 56 |
| serious Total, serious adverse events | 3 / 53 | 3 / 56 |
Outcome results
Primary
Degree of Dysphagia Patients Experience (Burden)
SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best)
Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Analysis performed on patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Degree of Dysphagia Patients Experience (Burden) | POD2 | 62.5 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Burden) | 3 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Burden) | POD1 | 50 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Burden) | 6 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Burden) | 4-6 weeks | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Burden) | 1 year | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Burden) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Burden) | 1 year | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Burden) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Burden) | POD1 | 75 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Burden) | POD2 | 75 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Burden) | 4-6 weeks | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Burden) | 3 months | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Burden) | 6 months | 100 score on a scale |
Comparison: The distribution of Pre-operative SWAL-QOL - Burden is the same across the 2 armsp-value: 0.394Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 SWAL-QOL - Burden is the same across the 2 armsp-value: 0.017Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD2 SWAL-QOL - Burden is the same across the 2 armsp-value: 0.015Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks SWAL-QOL - Burden is the same across the 2 armsp-value: 0.125Wilcoxon (Mann-Whitney)
Primary
Degree of Dysphagia Patients Experience (Communication)
SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best)
Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Degree of Dysphagia Patients Experience (Communication) | 1 year | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Communication) | Pre-operative | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Communication) | POD1 | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Communication) | POD2 | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Communication) | 4-6 weeks | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Communication) | 3 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Communication) | 6 months | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Communication) | 1 year | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Communication) | 4-6 weeks | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Communication) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Communication) | 6 months | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Communication) | POD1 | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Communication) | 3 months | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Communication) | POD2 | 100 score on a scale |
Comparison: The distribution of Pre-operative SWAL-QOL - Communication is the same across the 2 armsp-value: 0.037Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 SWAL-QOL - Communication is the same across the 2 armsp-value: 0.858Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD2 SWAL-QOL - Communication is the same across the 2 armsp-value: 0.042Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks SWAL-QOL - Communication is the same across the 2 armsp-value: 0.031Wilcoxon (Mann-Whitney)
Primary
Degree of Dysphagia Patients Experience (Eating Desire)
SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best)
Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Degree of Dysphagia Patients Experience (Eating Desire) | POD2 | 83.3 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Desire) | 3 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Desire) | POD1 | 83.3 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Desire) | 6 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Desire) | 4-6 weeks | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Desire) | 1 year | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Desire) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Desire) | 1 year | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Desire) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Desire) | POD1 | 87.5 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Desire) | POD2 | 91.7 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Desire) | 4-6 weeks | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Desire) | 3 months | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Desire) | 6 months | 100 score on a scale |
Comparison: The distribution of POD2 SWAL-QOL - Eating desire is the same across the 2 armsp-value: 0.155Wilcoxon (Mann-Whitney)
Comparison: The distribution of Pre-operative SWAL-QOL - Eating desire is the same across the 2 armsp-value: 0.043Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 SWAL-QOL - Eating desire is the same across the 2 armsp-value: 0.606Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks SWAL-QOL - Eating desire is the same across the 2 armsp-value: 0.019Wilcoxon (Mann-Whitney)
Primary
Degree of Dysphagia Patients Experience (Eating Duration)
SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best)
Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Degree of Dysphagia Patients Experience (Eating Duration) | POD2 | 50 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Duration) | 3 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Duration) | POD1 | 75 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Duration) | 6 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Duration) | 4-6 weeks | 87.5 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Duration) | 1 year | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Eating Duration) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Duration) | 1 year | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Duration) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Duration) | POD1 | 75 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Duration) | POD2 | 75 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Duration) | 4-6 weeks | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Duration) | 3 months | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Eating Duration) | 6 months | 100 score on a scale |
Comparison: The distribution of Pre-operative SWAL-QOL - Eating duration is the same across the 2 armsp-value: 0.25Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 SWAL-QOL - Eating duration is the same across the 2 armsp-value: 0.478Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD2 SWAL-QOL - Eating duration is the same across the 2 armsp-value: 0.019Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks SWAL-QOL - Eating duration is the same across the 2 armsp-value: 0.049Wilcoxon (Mann-Whitney)
Primary
Degree of Dysphagia Patients Experience (Fatigue)
SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best)
Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Degree of Dysphagia Patients Experience (Fatigue) | Pre-operative | 83.33 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fatigue) | 3 months | 75 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fatigue) | POD2 | 58.33 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fatigue) | 6 months | 75 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fatigue) | POD1 | 58.33 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fatigue) | 1 year | 75 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fatigue) | 4-6 weeks | 58.33 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fatigue) | 1 year | 91.67 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fatigue) | POD2 | 66.67 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fatigue) | Pre-operative | 83.33 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fatigue) | 4-6 weeks | 75 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fatigue) | 3 months | 83.33 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fatigue) | 6 months | 83.33 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fatigue) | POD1 | 58.33 score on a scale |
Comparison: The distribution of Pre-operative SWAL-QOL - Fatigue is the same across the 2 armsp-value: 0.602Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 SWAL-QOL - Fatigue is the same across the 2 armsp-value: 0.302Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD2 SWAL-QOL - Fatigue is the same across the 2 armsp-value: 0.114Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks SWAL-QOL - Fatigue is the same across the 2 armsp-value: 0.005Wilcoxon (Mann-Whitney)
Primary
Degree of Dysphagia Patients Experience (Fear Swallow)
SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best)
Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Degree of Dysphagia Patients Experience (Fear Swallow) | POD2 | 87.5 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fear Swallow) | 3 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fear Swallow) | POD1 | 93.75 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fear Swallow) | 6 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fear Swallow) | 4-6 weeks | 93.75 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fear Swallow) | 1 year | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Fear Swallow) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fear Swallow) | 1 year | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fear Swallow) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fear Swallow) | POD1 | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fear Swallow) | POD2 | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fear Swallow) | 4-6 weeks | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fear Swallow) | 3 months | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Fear Swallow) | 6 months | 100 score on a scale |
Comparison: The distribution of Pre-operative SWAL-QOL - Fear swallow is the same across the 2 armsp-value: 0.343Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 SWAL-QOL - Fear swallow is the same across the 2 armsp-value: 0.022Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD2 SWAL-QOL - Fear swallow is the same across the 2 armsp-value: 0.018Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks SWAL-QOL - Fear swallow is the same across the 2 armsp-value: 0.008Wilcoxon (Mann-Whitney)
Primary
Degree of Dysphagia Patients Experience (Food Selection)
SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best)
Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Degree of Dysphagia Patients Experience (Food Selection) | POD2 | 62.5 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Food Selection) | 3 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Food Selection) | POD1 | 75 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Food Selection) | 6 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Food Selection) | 4-6 weeks | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Food Selection) | 1 year | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Food Selection) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Food Selection) | 1 year | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Food Selection) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Food Selection) | POD1 | 93.75 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Food Selection) | POD2 | 75 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Food Selection) | 4-6 weeks | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Food Selection) | 3 months | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Food Selection) | 6 months | 100 score on a scale |
Comparison: The distribution of Pre-operative SWAL-QOL - Food selection is the same across the 2 armsp-value: 0.376Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 SWAL-QOL - Food selection is the same across the 2 armsp-value: 0.013Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD2 SWAL-QOL - Food selection is the same across the 2 armsp-value: 0.049Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks SWAL-QOL - Food selection is the same across the 2 armsp-value: 0.3Wilcoxon (Mann-Whitney)
Primary
Degree of Dysphagia Patients Experience (Mental)
SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best)
Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Degree of Dysphagia Patients Experience (Mental) | POD2 | 85 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Mental) | 3 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Mental) | POD1 | 80 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Mental) | 6 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Mental) | 4-6 weeks | 95 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Mental) | 1 year | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Mental) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Mental) | 1 year | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Mental) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Mental) | POD1 | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Mental) | POD2 | 97.5 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Mental) | 4-6 weeks | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Mental) | 3 months | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Mental) | 6 months | 100 score on a scale |
Comparison: The distribution of Pre-operative SWAL-QOL - Mental is the same across the 2 armsp-value: 0.148Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 SWAL-QOL - Mental is the same across the 2 armsp-value: 0.04Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD2 SWAL-QOL - Mental is the same across the 2 armsp-value: 0.042Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks SWAL-QOL - Mental is the same across the 2 armsp-value: 0.319Wilcoxon (Mann-Whitney)
Primary
Degree of Dysphagia Patients Experience (Sleep)
SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best)
Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Degree of Dysphagia Patients Experience (Sleep) | POD2 | 50 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Sleep) | 3 months | 62.5 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Sleep) | POD1 | 62.5 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Sleep) | 6 months | 62.5 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Sleep) | 4-6 weeks | 50 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Sleep) | 1 year | 75 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Sleep) | Pre-operative | 75 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Sleep) | 1 year | 87.5 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Sleep) | Pre-operative | 81.25 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Sleep) | POD1 | 56.25 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Sleep) | POD2 | 62.5 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Sleep) | 4-6 weeks | 75 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Sleep) | 3 months | 75 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Sleep) | 6 months | 75 score on a scale |
Comparison: The distribution of Pre-operative SWAL-QOL - Sleep is the same across the 2 armsp-value: 0.161Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 SWAL-QOL - Sleep is the same across the 2 armsp-value: 0.763Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD2 SWAL-QOL - Sleep is the same across the 2 armsp-value: 0.178Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks SWAL-QOL - Sleep is the same across the 2 armsp-value: 0.091Wilcoxon (Mann-Whitney)
Primary
Degree of Dysphagia Patients Experience (Social)
SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best)
Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Degree of Dysphagia Patients Experience (Social) | POD2 | 85 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Social) | 3 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Social) | POD1 | 95 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Social) | 6 months | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Social) | 4-6 weeks | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Social) | 1 year | 100 score on a scale |
| Control | Degree of Dysphagia Patients Experience (Social) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Social) | 1 year | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Social) | Pre-operative | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Social) | POD1 | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Social) | POD2 | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Social) | 4-6 weeks | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Social) | 3 months | 100 score on a scale |
| Treatment | Degree of Dysphagia Patients Experience (Social) | 6 months | 100 score on a scale |
Comparison: The distribution of Pre-operative SWAL-QOL - Social is the same across the 2 armsp-value: 0.28Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 SWAL-QOL - Social is the same across the 2 armsp-value: 0.483Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD2 SWAL-QOL - Social is the same across the 2 armsp-value: 0.07Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks SWAL-QOL - Social is the same across the 2 armsp-value: 0.2Wilcoxon (Mann-Whitney)
Secondary
Adverse Event
Adverse Event (AE) following surgical treatment. Adverse event were classified by severity based on the AO-ISSG criteria and treatment required: Mild: Observed, medication, consult, X-ray. Essentially any management that was quick and easy and could be done at bedside Moderate: ICU admission, re-intubation, complication that had a documented prolonged hospital stay, medical procedure (such as flexible endoscopy), re-presentation to ED Severe: Inpatient re-admission, return to OR for any reason, mortality, failed OR. AE were also categorize as Surgery-site related or unrelated adverse event. Finally, AE were also categorize as potentially related to steroid use (example: leukocytosis, pseudoarthrosis, or wound complications)
Time frame: 12 month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Adverse Event | Adverse Event Unrelated to Operated Site? | 26 Participants |
| Control | Adverse Event | Severe Adverse Event Unrelated to Operated Site? | 0 Participants |
| Control | Adverse Event | Mild/Moderate Adverse Event? | 42 Participants |
| Control | Adverse Event | Adverse Event Potentially Related to Steroid Use? | 11 Participants |
| Control | Adverse Event | Mild/Moderate Adverse Event Related to Operated Site? | 36 Participants |
| Control | Adverse Event | Adverse Event Unrelated to Steroid use? | 43 Participants |
| Control | Adverse Event | Adverse Event Related to Operated Site? | 38 Participants |
| Control | Adverse Event | Mild/Moderate Adverse Event Potentially Related to Steroid Use? | 9 Participants |
| Control | Adverse Event | Mild/Moderate Adverse Event Unrelated to Operated Site? | 26 Participants |
| Control | Adverse Event | Mild/Moderate Adverse Event Unrelated to Steroid use? | 42 Participants |
| Control | Adverse Event | Severe Adverse Event? | 3 Participants |
| Control | Adverse Event | Severe Adverse Event Potentially Related to Steroid Use? | 2 Participants |
| Control | Adverse Event | Severe Adverse Event Related to Operated Site? | 3 Participants |
| Control | Adverse Event | Severe Adverse Event Unrelated to Steroid use? | 1 Participants |
| Control | Adverse Event | Any Adverse Event? | 44 Participants |
| Treatment | Adverse Event | Severe Adverse Event Unrelated to Steroid use? | 2 Participants |
| Treatment | Adverse Event | Any Adverse Event? | 47 Participants |
| Treatment | Adverse Event | Mild/Moderate Adverse Event? | 46 Participants |
| Treatment | Adverse Event | Severe Adverse Event? | 3 Participants |
| Treatment | Adverse Event | Adverse Event Related to Operated Site? | 38 Participants |
| Treatment | Adverse Event | Adverse Event Unrelated to Operated Site? | 30 Participants |
| Treatment | Adverse Event | Mild/Moderate Adverse Event Related to Operated Site? | 37 Participants |
| Treatment | Adverse Event | Mild/Moderate Adverse Event Unrelated to Operated Site? | 30 Participants |
| Treatment | Adverse Event | Severe Adverse Event Related to Operated Site? | 3 Participants |
| Treatment | Adverse Event | Severe Adverse Event Unrelated to Operated Site? | 0 Participants |
| Treatment | Adverse Event | Adverse Event Potentially Related to Steroid Use? | 16 Participants |
| Treatment | Adverse Event | Adverse Event Unrelated to Steroid use? | 42 Participants |
| Treatment | Adverse Event | Mild/Moderate Adverse Event Potentially Related to Steroid Use? | 15 Participants |
| Treatment | Adverse Event | Mild/Moderate Adverse Event Unrelated to Steroid use? | 41 Participants |
| Treatment | Adverse Event | Severe Adverse Event Potentially Related to Steroid Use? | 1 Participants |
Secondary
Change in Pre-vertebral Soft Tissue Swelling Over 1 Year
We are unable to report this outcome measure because soft tissue swelling was not assessed. The PI deemed it would not be included for this study as there is not a clinical or research standard to do so, nor is there normative data over time to compare against. Thus, data were not collected.
Time frame: Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months
Population: We are unable to report this outcome measure because soft tissue swelling was not assessed. The PI deemed it would not be included for this study as there is not a clinical or research standard to do so, nor is there normative data over time to compare against.
Secondary
Fusion Rate
1. Flex-Ex X-rays 2. Bony bridging on a CT scan 3. Obvious bony remodeling on lateral X-ray
Time frame: 12 Months
Population: Subjects with 12 month follow up visit with X-rays. All others were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Fusion Rate | 25 Participants |
| Treatment | Fusion Rate | 23 Participants |
p-value: 0.99Fisher Exact
Secondary
Patient Reported Swallowing Difficulty Over 1 Year
The Eating Assessment Tool (EAT-10) is used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of OD. Modified Eat-10 : Eat-10 questionnaire without questions 1 (My swallowing problem has caused me to lose weight) and 2 (My swallowing problem interferes with my ability to go out for meals) to be applicable during hospitalization. Eat-10 interpretation: Score ranging from 0 to 40 (best-worst) * each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response Modified EAT-10 interpretation: Score ranging from 0 to 32 (best-worst) * each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Patient Reported Swallowing Difficulty Over 1 Year | Pre-operative Eat-10 | 0 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | Pre-operative Eat-10 modified | 0 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | POD1 Eat-10 | 16 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | POD1 Eat-10 modified | 14 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | POD2 Eat-10 | 16 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | POD2 Eat-10 modified | 14 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | 4-6 weeks Eat-10 | 5 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | 4-6 weeks Eat-10 modified | 4 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | 3 months Eat-10 | 2 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | 3 months Eat-10 modified | 2 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | 6 months Eat-10 | 1 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | 6 months Eat-10 modified | 1 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | 1 year Eat-10 | 0 score on a scale |
| Control | Patient Reported Swallowing Difficulty Over 1 Year | 1 year Eat-10 modified | 0 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | 6 months Eat-10 | 0 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | Pre-operative Eat-10 | 0 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | 4-6 weeks Eat-10 modified | 2 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | Pre-operative Eat-10 modified | 0 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | 1 year Eat-10 | 0 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | POD1 Eat-10 | 9 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | 3 months Eat-10 | 0 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | POD1 Eat-10 modified | 8.5 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | 6 months Eat-10 modified | 0 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | POD2 Eat-10 | 8 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | 3 months Eat-10 modified | 0 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | POD2 Eat-10 modified | 7 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | 1 year Eat-10 modified | 0 score on a scale |
| Treatment | Patient Reported Swallowing Difficulty Over 1 Year | 4-6 weeks Eat-10 | 2 score on a scale |
Comparison: The distribution of Pre-operative Eat-10 is the same across the 2 armsp-value: 0.933Wilcoxon (Mann-Whitney)
Comparison: The distribution of Pre-operative modified Eat-10 is the same across the 2 armsp-value: 0.95Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 Eat-10 is the same across the 2 armsp-value: 0.059Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD1 modified Eat-10 is the same across the 2 armsp-value: 0.042Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD2 Eat-10 is the same across the 2 armsp-value: 0.032Wilcoxon (Mann-Whitney)
Comparison: The distribution of POD2 modified Eat-10 is the same across the 2 armsp-value: 0.014Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks Eat-10 is the same across the 2 armsp-value: 0.03Wilcoxon (Mann-Whitney)
Comparison: The distribution of 4-6 weeks modified Eat-10 is the same across the 2 armsp-value: 0.039Wilcoxon (Mann-Whitney)
Secondary
Patients' Bazaz Dysphagia Score - Liquid
Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods.
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control | Patients' Bazaz Dysphagia Score - Liquid | Pre-operative | None | 47 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | Pre-operative | Rare | 6 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | POD1 | None | 20 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | POD1 | Rare | 33 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | POD2 | None | 17 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | POD2 | Rare | 34 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | 6-4 weeks | None | 35 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | 6-4 weeks | Rare | 18 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | 3 months | None | 39 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | 3 months | Rare | 11 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | 6 months | None | 42 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | 6 months | Rare | 9 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | 1 year | None | 35 Participants |
| Control | Patients' Bazaz Dysphagia Score - Liquid | 1 year | Rare | 10 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | 6 months | None | 41 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | Pre-operative | None | 54 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | 6-4 weeks | Rare | 17 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | Pre-operative | Rare | 2 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | 1 year | None | 40 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | POD1 | None | 36 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | 3 months | None | 39 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | POD1 | Rare | 20 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | 6 months | Rare | 10 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | POD2 | None | 23 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | 3 months | Rare | 13 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | POD2 | Rare | 31 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | 1 year | Rare | 7 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Liquid | 6-4 weeks | None | 39 Participants |
Comparison: Proportion of Pre-operative Bazaz Liquid is the same between the 2 armsp-value: 0.121Chi-squared
Comparison: Proportion of POD1 Bazaz Liquid is the same between the 2 armsp-value: 0.006Chi-squared
Comparison: Proportion of POD2 Bazaz Liquid is the same between the 2 armsp-value: 0.329Chi-squared
Comparison: Proportion of 4-6 weeks Bazaz Liquid is the same between the 2 armsp-value: 0.687Chi-squared
Secondary
Patients' Bazaz Dysphagia Score - Solid
Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods.
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control | Patients' Bazaz Dysphagia Score - Solid | 6-4 weeks | Occasionally (only with specific food) | 11 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | POD1 | None | 9 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 6-4 weeks | Frequent (majority of solids) | 6 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | POD2 | None | 6 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 3 months | None | 25 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | Pre-operative | Rare | 8 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 3 months | Rare | 11 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | POD2 | Rare | 9 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 3 months | Occasionally (only with specific food) | 12 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | POD1 | Rare | 8 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 3 months | Frequent (majority of solids) | 2 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | POD2 | Occasionally (only with specific food) | 19 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 6 months | None | 30 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | Pre-operative | Frequent (majority of solids) | 1 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 6 months | Rare | 15 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | POD2 | Frequent (majority of solids) | 17 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 6 months | Occasionally (only with specific food) | 5 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | POD1 | Occasionally (only with specific food) | 21 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 6 months | Frequent (majority of solids) | 1 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 6-4 weeks | None | 18 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 1 year | None | 29 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | Pre-operative | Occasionally (only with specific food) | 0 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 1 year | Rare | 7 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 6-4 weeks | Rare | 18 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 1 year | Occasionally (only with specific food) | 9 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | POD1 | Frequent (majority of solids) | 15 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | 1 year | Frequent (majority of solids) | 0 Participants |
| Control | Patients' Bazaz Dysphagia Score - Solid | Pre-operative | None | 44 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 1 year | Frequent (majority of solids) | 2 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | Pre-operative | None | 52 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | Pre-operative | Rare | 2 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | Pre-operative | Occasionally (only with specific food) | 2 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | Pre-operative | Frequent (majority of solids) | 0 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | POD1 | None | 17 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | POD1 | Rare | 11 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | POD1 | Occasionally (only with specific food) | 18 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | POD1 | Frequent (majority of solids) | 10 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | POD2 | None | 15 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | POD2 | Rare | 13 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | POD2 | Occasionally (only with specific food) | 15 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | POD2 | Frequent (majority of solids) | 11 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 6-4 weeks | None | 27 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 6-4 weeks | Rare | 16 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 6-4 weeks | Occasionally (only with specific food) | 11 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 6-4 weeks | Frequent (majority of solids) | 2 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 3 months | None | 34 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 3 months | Rare | 8 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 3 months | Occasionally (only with specific food) | 10 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 3 months | Frequent (majority of solids) | 0 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 6 months | None | 37 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 6 months | Rare | 10 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 6 months | Occasionally (only with specific food) | 3 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 6 months | Frequent (majority of solids) | 1 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 1 year | None | 35 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 1 year | Rare | 6 Participants |
| Treatment | Patients' Bazaz Dysphagia Score - Solid | 1 year | Occasionally (only with specific food) | 4 Participants |
Comparison: Proportion of Pre-operative Bazaz Solid is the same between the 2 armsp-value: 0.066Chi-squared
Comparison: Proportion of POD1 Bazaz Solid is the same between the 2 armsp-value: 0.252Chi-squared
Comparison: Proportion of POD2 Bazaz Solid is the same between the 2 armsp-value: 0.1Chi-squared
Comparison: Proportion of 4-6 weeks Bazaz Solid is the same between the 2 armsp-value: 0.279Chi-squared
Secondary
Patients' Neck Disability
Neck Disability Index (NDI) Range from 0 to 100 (best-worst)
Time frame: Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months
Population: People with completed follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Patients' Neck Disability | 4-6 weeks | 35.3 index | Standard Deviation 17.5 |
| Control | Patients' Neck Disability | 6 months | 23.9 index | Standard Deviation 17.7 |
| Control | Patients' Neck Disability | 3 months | 27.3 index | Standard Deviation 15.8 |
| Control | Patients' Neck Disability | 1 year | 20.6 index | Standard Deviation 17.9 |
| Control | Patients' Neck Disability | Pre-operative | 35.5 index | Standard Deviation 20.1 |
| Treatment | Patients' Neck Disability | 1 year | 13.2 index | Standard Deviation 12 |
| Treatment | Patients' Neck Disability | Pre-operative | 29.9 index | Standard Deviation 19.4 |
| Treatment | Patients' Neck Disability | 4-6 weeks | 30.8 index | Standard Deviation 20.6 |
| Treatment | Patients' Neck Disability | 3 months | 17.7 index | Standard Deviation 14.3 |
| Treatment | Patients' Neck Disability | 6 months | 15.4 index | Standard Deviation 13.8 |
Comparison: The means Pre-operative NDI for the two populations is equalp-value: 0.145t-test, 2 sided
Comparison: The means 4-6 weeks NDI for the two populations is equalp-value: 0.234t-test, 2 sided
Secondary
Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst)
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | POD2 | 5 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | 3 months | 5.8 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | POD1 | 10 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | 6 months | 2 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | 4-6 weeks | 6.45 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | 1 year | 4 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | Pre-operative | 17.5 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | 1 year | 1 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | Pre-operative | 19 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | POD1 | 5.35 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | POD2 | 6.45 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | 4-6 weeks | 2.75 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | 3 months | 2.5 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain | 6 months | 1.175 units on a scale |
Secondary
Patients' Pain Scores on the Visual Analog Scale - Neck Pain
Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst)
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | POD2 | 51 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | 3 months | 22 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | POD1 | 51.5 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | 6 months | 14 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | 4-6 weeks | 20 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | 1 year | 12.25 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | Pre-operative | 54.5 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | 1 year | 6.5 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | Pre-operative | 26 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | POD1 | 48.25 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | POD2 | 26.5 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | 4-6 weeks | 14.5 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | 3 months | 9.5 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Neck Pain | 6 months | 6 units on a scale |
Secondary
Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst)
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Population: Patient with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | POD1 | 2 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | 3 months | 4 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | Pre-operative | 20 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | 6 months | 6 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | 4-6 weeks | 7 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | 1 year | 3.5 units on a scale |
| Control | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | POD2 | 3 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | 1 year | 2.4 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | POD2 | 4 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | Pre-operative | 15.5 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | POD1 | 2.25 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | 4-6 weeks | 2 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | 3 months | 2 units on a scale |
| Treatment | Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain | 6 months | 2 units on a scale |