Trial Outcomes & Findings for Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion (NCT NCT02539394)
NCT ID: NCT02539394
Last Updated: 2023-07-10
Results Overview
SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
128 participants
Primary outcome timeframe
Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Results posted on
2023-07-10
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
64
|
|
Overall Study
COMPLETED
|
56
|
53
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Incomplete dataset
|
6
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment
n=56 Participants
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.
|
Control
n=53 Participants
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.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 10.5 • n=56 Participants
|
58.4 years
STANDARD_DEVIATION 11.5 • n=53 Participants
|
58.2 years
STANDARD_DEVIATION 11.0 • n=109 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=56 Participants
|
24 Participants
n=53 Participants
|
53 Participants
n=109 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=56 Participants
|
29 Participants
n=53 Participants
|
56 Participants
n=109 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
56 participants
n=56 Participants
|
53 participants
n=53 Participants
|
109 participants
n=109 Participants
|
|
Smoking status
Not Applicable
|
27 Participants
n=56 Participants
|
35 Participants
n=53 Participants
|
62 Participants
n=109 Participants
|
|
Smoking status
Former (quit > 30 days)
|
23 Participants
n=56 Participants
|
14 Participants
n=53 Participants
|
37 Participants
n=109 Participants
|
|
Smoking status
Current (within the last 30 days)
|
6 Participants
n=56 Participants
|
4 Participants
n=53 Participants
|
10 Participants
n=109 Participants
|
|
Diagnosis
Spondylosis
|
39 Participants
n=56 Participants
|
32 Participants
n=53 Participants
|
71 Participants
n=109 Participants
|
|
Diagnosis
Herniated disc
|
8 Participants
n=56 Participants
|
4 Participants
n=53 Participants
|
12 Participants
n=109 Participants
|
|
Diagnosis
Stenosis
|
10 Participants
n=56 Participants
|
10 Participants
n=53 Participants
|
20 Participants
n=109 Participants
|
|
Diagnosis
Osteoarthritis of the Cervical Spine
|
0 Participants
n=56 Participants
|
1 Participants
n=53 Participants
|
1 Participants
n=109 Participants
|
|
Diagnosis
Myelopathy
|
14 Participants
n=56 Participants
|
14 Participants
n=53 Participants
|
28 Participants
n=109 Participants
|
|
Diagnosis
Radiculopathy
|
31 Participants
n=56 Participants
|
23 Participants
n=53 Participants
|
54 Participants
n=109 Participants
|
|
Diagnosis
Myeloradiculopathy
|
15 Participants
n=56 Participants
|
17 Participants
n=53 Participants
|
32 Participants
n=109 Participants
|
|
Diagnosis
Cervical disk disorder
|
1 Participants
n=56 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=109 Participants
|
|
Diagnosis
Foraminal Stenosis
|
1 Participants
n=56 Participants
|
6 Participants
n=53 Participants
|
7 Participants
n=109 Participants
|
|
Diagnosis
Disk degrative disease
|
2 Participants
n=56 Participants
|
5 Participants
n=53 Participants
|
7 Participants
n=109 Participants
|
|
Charlson Comorbidities Index (CCI)
|
2 index
n=56 Participants
|
2 index
n=53 Participants
|
2 index
n=109 Participants
|
PRIMARY outcome
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Analysis performed on patient with completed follow-up
SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Degree of Dysphagia Patients Experience (Burden)
POD1
|
50 score on a scale
Interval 25.0 to 87.5
|
75 score on a scale
Interval 50.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Burden)
POD2
|
62.5 score on a scale
Interval 25.0 to 87.5
|
75 score on a scale
Interval 50.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Burden)
Pre-operative
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Burden)
4-6 weeks
|
100 score on a scale
Interval 62.5 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Burden)
3 months
|
100 score on a scale
Interval 87.5 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Burden)
6 months
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Burden)
1 year
|
100 score on a scale
Interval 87.5 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Degree of Dysphagia Patients Experience (Eating Desire)
Pre-operative
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Desire)
POD1
|
83.3 score on a scale
Interval 58.3 to 100.0
|
87.5 score on a scale
Interval 60.4 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Desire)
POD2
|
83.3 score on a scale
Interval 58.3 to 100.0
|
91.7 score on a scale
Interval 68.75 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Desire)
4-6 weeks
|
100 score on a scale
Interval 83.3 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Desire)
3 months
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Desire)
6 months
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Desire)
1 year
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Degree of Dysphagia Patients Experience (Eating Duration)
Pre-operative
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Duration)
POD1
|
75 score on a scale
Interval 25.0 to 93.75
|
75 score on a scale
Interval 37.5 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Duration)
POD2
|
50 score on a scale
Interval 18.75 to 87.5
|
75 score on a scale
Interval 37.5 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Duration)
4-6 weeks
|
87.5 score on a scale
Interval 43.75 to 100.0
|
100 score on a scale
Interval 75.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Duration)
3 months
|
100 score on a scale
Interval 75.0 to 100.0
|
100 score on a scale
Interval 87.5 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Duration)
6 months
|
100 score on a scale
Interval 87.5 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Eating Duration)
1 year
|
100 score on a scale
Interval 87.5 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Degree of Dysphagia Patients Experience (Food Selection)
Pre-operative
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Food Selection)
POD1
|
75 score on a scale
Interval 37.5 to 93.75
|
93.75 score on a scale
Interval 50.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Food Selection)
POD2
|
62.5 score on a scale
Interval 25.0 to 100.0
|
75 score on a scale
Interval 62.5 to 100.0
|
|
Degree of Dysphagia Patients Experience (Food Selection)
4-6 weeks
|
100 score on a scale
Interval 75.0 to 100.0
|
100 score on a scale
Interval 75.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Food Selection)
3 months
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Food Selection)
6 months
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Food Selection)
1 year
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Degree of Dysphagia Patients Experience (Communication)
Pre-operative
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Communication)
POD1
|
100 score on a scale
Interval 81.25 to 100.0
|
100 score on a scale
Interval 87.5 to 100.0
|
|
Degree of Dysphagia Patients Experience (Communication)
POD2
|
100 score on a scale
Interval 75.0 to 100.0
|
100 score on a scale
Interval 90.625 to 100.0
|
|
Degree of Dysphagia Patients Experience (Communication)
4-6 weeks
|
100 score on a scale
Interval 75.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Communication)
3 months
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Communication)
6 months
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Communication)
1 year
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Degree of Dysphagia Patients Experience (Fear Swallow)
Pre-operative
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Fear Swallow)
POD1
|
93.75 score on a scale
Interval 75.0 to 100.0
|
100 score on a scale
Interval 87.5 to 100.0
|
|
Degree of Dysphagia Patients Experience (Fear Swallow)
POD2
|
87.5 score on a scale
Interval 56.25 to 100.0
|
100 score on a scale
Interval 76.6 to 100.0
|
|
Degree of Dysphagia Patients Experience (Fear Swallow)
4-6 weeks
|
93.75 score on a scale
Interval 84.4 to 100.0
|
100 score on a scale
Interval 87.5 to 100.0
|
|
Degree of Dysphagia Patients Experience (Fear Swallow)
3 months
|
100 score on a scale
Interval 87.5 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Fear Swallow)
6 months
|
100 score on a scale
Interval 93.75 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Fear Swallow)
1 year
|
100 score on a scale
Interval 87.5 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Degree of Dysphagia Patients Experience (Social)
Pre-operative
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Social)
POD1
|
95 score on a scale
Interval 67.5 to 100.0
|
100 score on a scale
Interval 75.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Social)
POD2
|
85 score on a scale
Interval 25.0 to 100.0
|
100 score on a scale
Interval 56.25 to 100.0
|
|
Degree of Dysphagia Patients Experience (Social)
4-6 weeks
|
100 score on a scale
Interval 85.0 to 100.0
|
100 score on a scale
Interval 95.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Social)
3 months
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Social)
6 months
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Social)
1 year
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Degree of Dysphagia Patients Experience (Mental)
Pre-operative
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Mental)
POD1
|
80 score on a scale
Interval 50.0 to 100.0
|
100 score on a scale
Interval 75.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Mental)
POD2
|
85 score on a scale
Interval 50.0 to 100.0
|
97.5 score on a scale
Interval 70.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Mental)
4-6 weeks
|
95 score on a scale
Interval 77.5 to 100.0
|
100 score on a scale
Interval 80.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Mental)
3 months
|
100 score on a scale
Interval 85.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Mental)
6 months
|
100 score on a scale
Interval 95.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Degree of Dysphagia Patients Experience (Mental)
1 year
|
100 score on a scale
Interval 90.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Degree of Dysphagia Patients Experience (Sleep)
3 months
|
62.5 score on a scale
Interval 50.0 to 87.5
|
75 score on a scale
Interval 62.5 to 100.0
|
|
Degree of Dysphagia Patients Experience (Sleep)
Pre-operative
|
75 score on a scale
Interval 50.0 to 100.0
|
81.25 score on a scale
Interval 62.5 to 100.0
|
|
Degree of Dysphagia Patients Experience (Sleep)
POD1
|
62.5 score on a scale
Interval 37.5 to 75.0
|
56.25 score on a scale
Interval 37.5 to 87.5
|
|
Degree of Dysphagia Patients Experience (Sleep)
POD2
|
50 score on a scale
Interval 25.0 to 75.0
|
62.5 score on a scale
Interval 50.0 to 75.0
|
|
Degree of Dysphagia Patients Experience (Sleep)
4-6 weeks
|
50 score on a scale
Interval 37.5 to 81.25
|
75 score on a scale
Interval 50.0 to 87.5
|
|
Degree of Dysphagia Patients Experience (Sleep)
6 months
|
62.5 score on a scale
Interval 50.0 to 100.0
|
75 score on a scale
Interval 62.5 to 100.0
|
|
Degree of Dysphagia Patients Experience (Sleep)
1 year
|
75 score on a scale
Interval 50.0 to 87.5
|
87.5 score on a scale
Interval 50.0 to 100.0
|
PRIMARY outcome
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Degree of Dysphagia Patients Experience (Fatigue)
Pre-operative
|
83.33 score on a scale
Interval 54.17 to 100.0
|
83.33 score on a scale
Interval 60.42 to 100.0
|
|
Degree of Dysphagia Patients Experience (Fatigue)
POD1
|
58.33 score on a scale
Interval 25.0 to 70.83
|
58.33 score on a scale
Interval 25.0 to 83.33
|
|
Degree of Dysphagia Patients Experience (Fatigue)
POD2
|
58.33 score on a scale
Interval 33.33 to 75.0
|
66.67 score on a scale
Interval 41.67 to 83.33
|
|
Degree of Dysphagia Patients Experience (Fatigue)
4-6 weeks
|
58.33 score on a scale
Interval 41.67 to 75.0
|
75 score on a scale
Interval 58.33 to 97.92
|
|
Degree of Dysphagia Patients Experience (Fatigue)
3 months
|
75 score on a scale
Interval 58.33 to 91.67
|
83.33 score on a scale
Interval 70.83 to 100.0
|
|
Degree of Dysphagia Patients Experience (Fatigue)
6 months
|
75 score on a scale
Interval 58.33 to 91.67
|
83.33 score on a scale
Interval 66.67 to 100.0
|
|
Degree of Dysphagia Patients Experience (Fatigue)
1 year
|
75 score on a scale
Interval 66.67 to 91.67
|
91.67 score on a scale
Interval 66.67 to 100.0
|
SECONDARY outcome
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
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
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Patient Reported Swallowing Difficulty Over 1 Year
Pre-operative Eat-10
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Patient Reported Swallowing Difficulty Over 1 Year
Pre-operative Eat-10 modified
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Patient Reported Swallowing Difficulty Over 1 Year
POD1 Eat-10
|
16 score on a scale
Interval 7.0 to 19.5
|
9 score on a scale
Interval 4.25 to 20.75
|
|
Patient Reported Swallowing Difficulty Over 1 Year
POD1 Eat-10 modified
|
14 score on a scale
Interval 7.0 to 19.5
|
8.5 score on a scale
Interval 4.0 to 18.0
|
|
Patient Reported Swallowing Difficulty Over 1 Year
POD2 Eat-10
|
16 score on a scale
Interval 7.0 to 25.5
|
8 score on a scale
Interval 3.25 to 21.75
|
|
Patient Reported Swallowing Difficulty Over 1 Year
POD2 Eat-10 modified
|
14 score on a scale
Interval 7.0 to 20.5
|
7 score on a scale
Interval 3.0 to 17.75
|
|
Patient Reported Swallowing Difficulty Over 1 Year
4-6 weeks Eat-10
|
5 score on a scale
Interval 0.0 to 11.5
|
2 score on a scale
Interval 0.0 to 6.0
|
|
Patient Reported Swallowing Difficulty Over 1 Year
4-6 weeks Eat-10 modified
|
4 score on a scale
Interval 0.0 to 9.5
|
2 score on a scale
Interval 0.0 to 5.0
|
|
Patient Reported Swallowing Difficulty Over 1 Year
3 months Eat-10
|
2 score on a scale
Interval 0.0 to 6.0
|
0 score on a scale
Interval 0.0 to 4.0
|
|
Patient Reported Swallowing Difficulty Over 1 Year
3 months Eat-10 modified
|
2 score on a scale
Interval 0.0 to 6.0
|
0 score on a scale
Interval 0.0 to 4.0
|
|
Patient Reported Swallowing Difficulty Over 1 Year
6 months Eat-10
|
1 score on a scale
Interval 0.0 to 5.0
|
0 score on a scale
Interval 0.0 to 2.0
|
|
Patient Reported Swallowing Difficulty Over 1 Year
6 months Eat-10 modified
|
1 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 2.0
|
|
Patient Reported Swallowing Difficulty Over 1 Year
1 year Eat-10
|
0 score on a scale
Interval 0.0 to 5.0
|
0 score on a scale
Interval 0.0 to 2.0
|
|
Patient Reported Swallowing Difficulty Over 1 Year
1 year Eat-10 modified
|
0 score on a scale
Interval 0.0 to 5.0
|
0 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods.
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Patients' Bazaz Dysphagia Score - Liquid
POD1 · None
|
20 Participants
|
36 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
Pre-operative · None
|
47 Participants
|
54 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
Pre-operative · Rare
|
6 Participants
|
2 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
POD1 · Rare
|
33 Participants
|
20 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
POD2 · None
|
17 Participants
|
23 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
POD2 · Rare
|
34 Participants
|
31 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
6-4 weeks · None
|
35 Participants
|
39 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
6-4 weeks · Rare
|
18 Participants
|
17 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
3 months · None
|
39 Participants
|
39 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
3 months · Rare
|
11 Participants
|
13 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
6 months · None
|
42 Participants
|
41 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
6 months · Rare
|
9 Participants
|
10 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
1 year · None
|
35 Participants
|
40 Participants
|
|
Patients' Bazaz Dysphagia Score - Liquid
1 year · Rare
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods.
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Patients' Bazaz Dysphagia Score - Solid
POD1 · None
|
9 Participants
|
17 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
POD1 · Rare
|
8 Participants
|
11 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
6-4 weeks · None
|
18 Participants
|
27 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
6-4 weeks · Rare
|
18 Participants
|
16 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
Pre-operative · None
|
44 Participants
|
52 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
Pre-operative · Rare
|
8 Participants
|
2 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
Pre-operative · Occasionally (only with specific food)
|
0 Participants
|
2 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
Pre-operative · Frequent (majority of solids)
|
1 Participants
|
0 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
POD1 · Occasionally (only with specific food)
|
21 Participants
|
18 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
POD1 · Frequent (majority of solids)
|
15 Participants
|
10 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
POD2 · None
|
6 Participants
|
15 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
POD2 · Rare
|
9 Participants
|
13 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
POD2 · Occasionally (only with specific food)
|
19 Participants
|
15 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
POD2 · Frequent (majority of solids)
|
17 Participants
|
11 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
6-4 weeks · Occasionally (only with specific food)
|
11 Participants
|
11 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
6-4 weeks · Frequent (majority of solids)
|
6 Participants
|
2 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
3 months · None
|
25 Participants
|
34 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
3 months · Rare
|
11 Participants
|
8 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
3 months · Occasionally (only with specific food)
|
12 Participants
|
10 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
3 months · Frequent (majority of solids)
|
2 Participants
|
0 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
6 months · None
|
30 Participants
|
37 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
6 months · Rare
|
15 Participants
|
10 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
6 months · Occasionally (only with specific food)
|
5 Participants
|
3 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
6 months · Frequent (majority of solids)
|
1 Participants
|
1 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
1 year · None
|
29 Participants
|
35 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
1 year · Rare
|
7 Participants
|
6 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
1 year · Occasionally (only with specific food)
|
9 Participants
|
4 Participants
|
|
Patients' Bazaz Dysphagia Score - Solid
1 year · Frequent (majority of solids)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Pre-Op, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: People with completed follow-up
Neck Disability Index (NDI) Range from 0 to 100 (best-worst)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Patients' Neck Disability
Pre-operative
|
35.5 index
Standard Deviation 20.1
|
29.9 index
Standard Deviation 19.4
|
|
Patients' Neck Disability
4-6 weeks
|
35.3 index
Standard Deviation 17.5
|
30.8 index
Standard Deviation 20.6
|
|
Patients' Neck Disability
3 months
|
27.3 index
Standard Deviation 15.8
|
17.7 index
Standard Deviation 14.3
|
|
Patients' Neck Disability
6 months
|
23.9 index
Standard Deviation 17.7
|
15.4 index
Standard Deviation 13.8
|
|
Patients' Neck Disability
1 year
|
20.6 index
Standard Deviation 17.9
|
13.2 index
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Patients' Pain Scores on the Visual Analog Scale - Neck Pain
4-6 weeks
|
20 units on a scale
Interval 5.5 to 40.0
|
14.5 units on a scale
Interval 4.5 to 30.25
|
|
Patients' Pain Scores on the Visual Analog Scale - Neck Pain
3 months
|
22 units on a scale
Interval 5.0 to 49.0
|
9.5 units on a scale
Interval 2.0 to 25.0
|
|
Patients' Pain Scores on the Visual Analog Scale - Neck Pain
Pre-operative
|
54.5 units on a scale
Interval 22.5 to 70.0
|
26 units on a scale
Interval 5.8 to 61.5
|
|
Patients' Pain Scores on the Visual Analog Scale - Neck Pain
POD1
|
51.5 units on a scale
Interval 25.0 to 77.0
|
48.25 units on a scale
Interval 8.025 to 61.125
|
|
Patients' Pain Scores on the Visual Analog Scale - Neck Pain
POD2
|
51 units on a scale
Interval 21.5 to 69.0
|
26.5 units on a scale
Interval 11.5 to 49.125
|
|
Patients' Pain Scores on the Visual Analog Scale - Neck Pain
6 months
|
14 units on a scale
Interval 5.5 to 45.0
|
6 units on a scale
Interval 1.5 to 19.375
|
|
Patients' Pain Scores on the Visual Analog Scale - Neck Pain
1 year
|
12.25 units on a scale
Interval 0.7 to 52.125
|
6.5 units on a scale
Interval 0.875 to 14.125
|
SECONDARY outcome
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
Pre-operative
|
17.5 units on a scale
Interval 1.0 to 52.0
|
19 units on a scale
Interval 2.1 to 53.9
|
|
Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
POD1
|
10 units on a scale
Interval 0.0 to 38.0
|
5.35 units on a scale
Interval 0.0 to 17.0
|
|
Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
POD2
|
5 units on a scale
Interval 0.0 to 38.0
|
6.45 units on a scale
Interval 0.0 to 16.5
|
|
Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
4-6 weeks
|
6.45 units on a scale
Interval 0.0 to 28.0
|
2.75 units on a scale
Interval 0.125 to 13.0
|
|
Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
3 months
|
5.8 units on a scale
Interval 0.0 to 16.0
|
2.5 units on a scale
Interval 0.0 to 16.0
|
|
Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
6 months
|
2 units on a scale
Interval 0.0 to 17.5
|
1.175 units on a scale
Interval 0.0 to 11.0
|
|
Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
1 year
|
4 units on a scale
Interval 0.0 to 21.5
|
1 units on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: Patient with completed follow-up
Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
1 year
|
3.5 units on a scale
Interval 0.0 to 26.25
|
2.4 units on a scale
Interval 0.0 to 9.0
|
|
Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
Pre-operative
|
20 units on a scale
Interval 2.0 to 67.0
|
15.5 units on a scale
Interval 0.0 to 38.4
|
|
Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
POD1
|
2 units on a scale
Interval 0.0 to 20.5
|
2.25 units on a scale
Interval 0.0 to 10.0
|
|
Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
POD2
|
3 units on a scale
Interval 0.0 to 22.0
|
4 units on a scale
Interval 0.0 to 16.0
|
|
Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
4-6 weeks
|
7 units on a scale
Interval 0.0 to 32.0
|
2 units on a scale
Interval 0.0 to 11.9
|
|
Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
3 months
|
4 units on a scale
Interval 0.0 to 30.0
|
2 units on a scale
Interval 0.0 to 15.0
|
|
Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
6 months
|
6 units on a scale
Interval 0.0 to 40.0
|
2 units on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 MonthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Subjects with 12 month follow up visit with X-rays. All others were excluded.
1. Flex-Ex X-rays 2. Bony bridging on a CT scan 3. Obvious bony remodeling on lateral X-ray
Outcome measures
| Measure |
Control
n=50 Participants
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.
|
Treatment
n=45 Participants
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.
|
|---|---|---|
|
Fusion Rate
|
25 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 12 monthAdverse 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)
Outcome measures
| Measure |
Control
n=53 Participants
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.
|
Treatment
n=56 Participants
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.
|
|---|---|---|
|
Adverse Event
Any Adverse Event?
|
44 Participants
|
47 Participants
|
|
Adverse Event
Adverse Event Related to Operated Site?
|
38 Participants
|
38 Participants
|
|
Adverse Event
Mild/Moderate Adverse Event Related to Operated Site?
|
36 Participants
|
37 Participants
|
|
Adverse Event
Mild/Moderate Adverse Event Unrelated to Operated Site?
|
26 Participants
|
30 Participants
|
|
Adverse Event
Severe Adverse Event Potentially Related to Steroid Use?
|
2 Participants
|
1 Participants
|
|
Adverse Event
Severe Adverse Event Unrelated to Steroid use?
|
1 Participants
|
2 Participants
|
|
Adverse Event
Adverse Event Potentially Related to Steroid Use?
|
11 Participants
|
16 Participants
|
|
Adverse Event
Mild/Moderate Adverse Event?
|
42 Participants
|
46 Participants
|
|
Adverse Event
Severe Adverse Event?
|
3 Participants
|
3 Participants
|
|
Adverse Event
Adverse Event Unrelated to Operated Site?
|
26 Participants
|
30 Participants
|
|
Adverse Event
Severe Adverse Event Related to Operated Site?
|
3 Participants
|
3 Participants
|
|
Adverse Event
Severe Adverse Event Unrelated to Operated Site?
|
0 Participants
|
0 Participants
|
|
Adverse Event
Adverse Event Unrelated to Steroid use?
|
43 Participants
|
42 Participants
|
|
Adverse Event
Mild/Moderate Adverse Event Potentially Related to Steroid Use?
|
9 Participants
|
15 Participants
|
|
Adverse Event
Mild/Moderate Adverse Event Unrelated to Steroid use?
|
42 Participants
|
41 Participants
|
Adverse Events
Control
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Treatment
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=53 participants at risk
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.
|
Treatment
n=56 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
GastroIntestinal
|
0.00%
0/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
1.8%
1/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
Musculoskeletal and connective tissue disorders
Skeletal
|
5.7%
3/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
3.6%
2/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
Other adverse events
| Measure |
Control
n=53 participants at risk
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.
|
Treatment
n=56 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Cardiovascular
|
32.1%
17/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
26.8%
15/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
General disorders
Digestive
|
1.9%
1/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
0.00%
0/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
Endocrine disorders
Endocrine
|
0.00%
0/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
10.7%
6/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
Reproductive system and breast disorders
Genitourinary
|
1.9%
1/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
0.00%
0/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
Gastrointestinal disorders
Gastrointestinal
|
45.3%
24/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
41.1%
23/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
Blood and lymphatic system disorders
Hematologic
|
13.2%
7/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
16.1%
9/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
Immune system disorders
Immune
|
1.9%
1/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
1.8%
1/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
3.8%
2/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
1.8%
1/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
Nervous system disorders
Neurologic
|
1.9%
1/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
5.4%
3/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
General disorders
Pain
|
35.8%
19/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
50.0%
28/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
18.9%
10/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
10.7%
6/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
Musculoskeletal and connective tissue disorders
Skeletal
|
0.00%
0/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
0.00%
0/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
|
Surgical and medical procedures
Wound
|
9.4%
5/53 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
5.4%
3/56 • 12 months
For standardization for mild-mod-severe AE was mostly based on the AO-ISSG criteria: 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place