Effect of Topical Corticosteroids on Dysphagia in Anterio... | NCT02539394

NCT02539394

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	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.	Drug: Methylprednisolone Acetate Other: Hemostatic Matrix Kit
Control	Placebo Comparator	Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.	Other: Hemostatic Matrix Kit

Name	Type	Description	Arm Group Labels	Other Names
Methylprednisolone Acetate	Drug	Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of Dysphagia Patients Experience (Burden)	SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Eating Desire)	SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Eating Duration)	SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Food Selection)	SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Communication)	SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Fear Swallow)	SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Social)

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Todd Albert, MD	Hospital for Special Surgery, New York	Principal Investigator

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 23, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00056 BG00153 BG002109

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Pre-operative

- ParticipantsOG00053
- ParticipantsOG00156

Title	Measurements
	OG000100(100 to 100)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The distribution of Pre-operative SWAL-QOL - Burden is the same across the 2 arms	Wilcoxon (Mann-Whitney)		0.394														Equivalence	43 patient in each group need to achieved >80% power to detect a 15 point differences in SWAL-QOL survey
OG000 OG001

Primary

Degree of Dysphagia Patients Experience (Eating Desire)

SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

score on a scale

Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Primary

Degree of Dysphagia Patients Experience (Eating Duration)

SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

score on a scale

Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Primary

Degree of Dysphagia Patients Experience (Food Selection)

SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

score on a scale

Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Primary

Degree of Dysphagia Patients Experience (Communication)

SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

score on a scale

Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Primary

Degree of Dysphagia Patients Experience (Fear Swallow)

SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

score on a scale

Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Primary

Degree of Dysphagia Patients Experience (Social)

SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

score on a scale

Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Primary

Degree of Dysphagia Patients Experience (Mental)

SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

score on a scale

Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Primary

Degree of Dysphagia Patients Experience (Sleep)

SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

score on a scale

Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Primary

Degree of Dysphagia Patients Experience (Fatigue)

SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

score on a scale

Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

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

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

score on a scale

Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

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.

Patient with completed follow-up

Posted

Count of Participants

Participants

Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

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.

Patient with completed follow-up

Posted

Count of Participants

Participants

Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Patients' Neck Disability

Neck Disability Index (NDI) Range from 0 to 100 (best-worst)

People with completed follow-up

Posted

Mean

Standard Deviation

index

Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Patients' Pain Scores on the Visual Analog Scale - Neck Pain

Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

units on a scale

Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

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)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

units on a scale

Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

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)

Patient with completed follow-up

Posted

Median

Inter-Quartile Range

units on a scale

Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
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.

Posted

Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Fusion Rate

Flex-Ex X-rays
Bony bridging on a CT scan
Obvious bony remodeling on lateral X-ray

Subjects with 12 month follow up visit with X-rays. All others were excluded.

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

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)

Posted

Count of Participants

Participants

12 month

ID	Title	Description
OG000	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	53	3	53	42	53
EG001	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.	0	56	3	56	46	56

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
GastroIntestinal	Gastrointestinal disorders		Non-systematic Assessment	Constipation, Dysphagia, Nausea / Vomiting, Reflux	EG0000 affected53 at risk EG0011 affected56 at risk
Skeletal	Musculoskeletal and connective tissue disorders		Non-systematic Assessment	Hardware Complication, Pseudoarthrosis	EG0003 affected53 at risk EG0012 affected56 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Cardiovascular	Cardiac disorders	Non-systematic Assessment	ABLA, Acute Cardiac, Arrhythmia, DVT, Hyperkalemia, Hypertension, Hyponatremia, Hypotension/Hypovolemia, Leukocytosis, VTE	EG00017 affected53 at risk EG00115 affected56 at risk
Digestive	General disorders	Non-systematic Assessment	Dysphagia	EG0001 affected53 at risk EG0010 affected56 at risk
Endocrine	Endocrine disorders	Non-systematic Assessment	Hyperglycemia	EG0000 affected53 at risk EG0016 affected56 at risk
Genitourinary	Reproductive system and breast disorders	Non-systematic Assessment	Urinary Retention	EG0001 affected53 at risk EG0010 affected56 at risk
Gastrointestinal	Gastrointestinal disorders	Non-systematic Assessment	Constipation, Dysphagia, Nausea / Vomiting, Reflux	EG00024 affected53 at risk EG00123 affected56 at risk
Hematologic	Blood and lymphatic system disorders	Non-systematic Assessment	Leukocytosis	EG0007 affected53 at risk EG0019 affected56 at risk
Immune	Immune system disorders	Non-systematic Assessment		EG0001 affected53 at risk EG0011 affected56 at risk
Integumentary	Skin and subcutaneous tissue disorders	Non-systematic Assessment		EG0002 affected53 at risk EG0011 affected56 at risk
Neurologic	Nervous system disorders	Non-systematic Assessment	Dizziness/Vertigo, Migraine	EG0001 affected53 at risk EG0013 affected56 at risk
Pain	General disorders	Non-systematic Assessment	Non-Radicular, Radicular	EG00019 affected53 at risk EG00128 affected56 at risk
Respiratory	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	Aspiration, Atelectasis, Hypoxia	EG00010 affected53 at risk EG0016 affected56 at risk
Skeletal	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	Hardware Complication, Pseudoarthrosis	EG0000 affected53 at risk EG0010 affected56 at risk
Wound	Surgical and medical procedures	Non-systematic Assessment	Hematoma, Infection, SSI	EG0005 affected53 at risk EG0013 affected56 at risk

ID	Term
D003680	Deglutition Disorders

ID	Term
D000077555	Methylprednisolone Acetate

ParticipantsBG002109

OG001100(100 to 100)

The distribution of POD1 SWAL-QOL - Burden is the same across the 2 arms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases
D010038	Otorhinolaryngologic Diseases

ID	Term
D008775	Methylprednisolone
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds