Cervical Disc HerniationNCT02539394

Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion

A study testing Methylprednisolone Acetate and Hemostatic Matrix Kit in people with Cervical Disc Herniation and Cervical Degenerative Disc Disease, run by Hospital for Special Surgery, New York.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cervical Disc Herniation, Cervical Degenerative Disc Disease, Cervical Spondylotic Myelopathy
What is being tested?: Methylprednisolone Acetate and Hemostatic Matrix Kit
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 128 participants
Where: No sites listed yet
Study dates: Aug 2015to 12 Nov 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Any patient > 18 years undergoing a 2-4 level Anterior Cervical Discectomy and Fusion

Who cannot join

Patients undergoing revision surgery
Pediatric patients
Trauma patients with cervical spine fractures
Patients with cancer
Patients with active infection
Patients with a known allergy to Methylprednisolone Acetate
Patients who refuse to participate
Non English speakers

About this study

Official title: Do Intraoperative Topical Corticosteroids Aid in the Prevention of Postoperative Dysphagia Following Elective Anterior Cervical Discectomy and Fusion? A Randomized, Controlled, Double Blinded Clinical Trial

The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.

Read the detailed description

Background: Dysphagia is a serious post-operative concern in patients following anterior cervical surgery. Although many experts have acknowledged that dysphagia is often incompletely understood and defined, there is a significant amount of literature to support the significance of this clinical entity. This is the first randomized study to examine the use of topical steroids for the prevention of dysphagia postoperatively after anterior cervical discectomy and fusion.

Study Design: This study is a single site, double blinded randomized control trial. All individuals undergoing 2-4 level ACDF that meet the inclusion criteria will be randomized to either:

treatment arm or
control arm.

Both arms will undergo their planned surgeries and will receive the exact same procedure and standard of care as if they were not enrolled in a study. The only difference is that the treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with one Hemostatic Matrix Kit injectable delivery vehicle prior to closure in the prevertebral soft tissues. The control group will receive only Hemostatic Matrix Kit prior to closure in the prevertebral soft tissues.

Outcomes: Patients will be asked to fill out questionnaires that assess dysphagia, general swallowing difficulty, and how neck pain impacts their quality of life. Additionally Radiographic images will be obtained at set time points to evaluate soft tissue inflammation and bony fusion.

Conditions: Cervical Disc Herniation, Cervical Degenerative Disc Disease, Cervical Spondylotic Myelopathy, Dysphagia, Osteoarthritis of Cervical Spine
Being tested: Methylprednisolone Acetate, Hemostatic Matrix Kit
Keywords: Anterior Cervical Discectomy and Fusion, Dysphagia, ACDF
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Methylprednisolone AcetateDrug
Also called Depo-Medrol
Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.
Hemostatic Matrix KitOther
Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.

Study groups in NCT02539394
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Hemostatic Matrix Kit

What is being measured

The primary outcome is the main question the study is designed to answer.

Degree of Dysphagia Patients Experience (Burden)
SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Social)
SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best)
Measured: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Mental)
SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best)
Measured: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Sleep)
SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best)
Measured: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Fatigue)
SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best)
Measured: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

Secondary outcomes (10)

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
Measured: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
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.
Measured: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
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.
Measured: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Neck Disability
Neck Disability Index (NDI) Range from 0 to 100 (best-worst)
Measured: Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Pain Scores on the Visual Analog Scale - Neck Pain
Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst)
Measured: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
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)
Measured: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
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)
Measured: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
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.
Measured: Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months
Fusion Rate
1. Flex-Ex X-rays
2. Bony bridging on a CT scan
3. Obvious bony remodeling on lateral X-ray
Measured: 12 Months
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)
Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201512 Nov 2021

First posted3 Sep 2015 (estimated)
Study startAug 2015
Primary completion12 Nov 2020
Study completion12 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cervical Disc HerniationStudies of the same condition, open and under way.
More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02539394
Sponsor's protocol ID: 2014-145
Status last verified: Jun 2023
First submitted: 27 Aug 2015
Last updated: 10 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Active, not recruiting
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
RecruitingObservational study
Gelified Radiopaque Ethanol (Absolute Gel) in Cervical Disc Herniation: an Observational Study in Routine Clinical Practice (GENESIS)
Cervical Disc Herniation, Intervertebral Disc Displacement
Not yet recruiting
Action Observation and Motor Imagery Training in Cervical Disc Herniation
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All Cervical Disc Herniation trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Do Intraoperative Topical Corticosteroids Aid in the Prevention of Postoperative Dysphagia Following Elective Anterior Cervical Discectomy and Fusion? A Randomized, Controlled, Double Blinded Clinical Trial
ClinicalTrials.gov ID: NCT02539394
Acronym / sponsor ID: 2014-145
Conditions: Cervical Disc Herniation, Cervical Degenerative Disc Disease, Cervical Spondylotic Myelopathy, Dysphagia, Osteoarthritis of Cervical Spine
Keywords: Anterior Cervical Discectomy and Fusion, Dysphagia, ACDF
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: Aug 2015
Primary completion: 12 Nov 2020 (actual)
Study completion: 12 Nov 2021 (actual)
First posted: 3 Sep 2015 (estimated)
Results: Posted 10 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.

Detailed description

Study Design: This study is a single site, double blinded randomized control trial. All individuals undergoing 2-4 level ACDF that meet the inclusion criteria will be randomized to either:

treatment arm or
control arm.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Drug: Methylprednisolone Acetate, Other: Hemostatic Matrix KitProcedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.
Control	Placebo comparator	Other: Hemostatic Matrix KitProcedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Any patient > 18 years undergoing a 2-4 level Anterior Cervical Discectomy and Fusion

Key exclusion criteria (8 listed)

Patients undergoing revision surgery
Pediatric patients
Trauma patients with cervical spine fractures
Patients with cancer
Patients with active infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Methylprednisolone AcetateAlso: Depo-MedrolMethylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.	Drug	Treatment
Hemostatic Matrix KitHemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.	Other	Control, Treatment

Primary outcome

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

10 secondary outcomes

Patient Reported Swallowing Difficulty Over 1 Year
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Bazaz Dysphagia Score - Liquid
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Bazaz Dysphagia Score - Solid
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Neck Disability
Time frame: Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Pain Scores on the Visual Analog Scale - Neck Pain
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
Time frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Change in Pre-vertebral Soft Tissue Swelling Over 1 Year
Time frame: Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months
Fusion Rate
Time frame: 12 Months
Adverse Event
Time frame: 12 month

Results and safety

Results posted to the registry on 10 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	64	56
Control	64	53

Primary outcome: Degree of Dysphagia Patients Experience (Burden)

Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Control n = 53	Treatment n = 56
Pre-operative	100 (100 to 100)	100 (100 to 100)
POD1	50 (25 to 87.5)	75 (50 to 100)
POD2	62.5 (25 to 87.5)	75 (50 to 100)
4-6 weeks	100 (62.5 to 100)	100 (100 to 100)
3 months	100 (87.5 to 100)	100 (100 to 100)
6 months	100 (100 to 100)	100 (100 to 100)
1 year	100 (87.5 to 100)	100 (100 to 100)

Control vs Treatment: p = 0.394, Wilcoxon (Mann-Whitney)
Control vs Treatment: p = 0.017, Wilcoxon (Mann-Whitney)
Control vs Treatment: p = 0.015, Wilcoxon (Mann-Whitney)

Population analysed: Analysis performed on patient with completed follow-up

Primary outcome: Degree of Dysphagia Patients Experience (Eating Desire)

Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Control n = 53	Treatment n = 56
Pre-operative	100 (100 to 100)	100 (100 to 100)
POD1	83.3 (58.3 to 100)	87.5 (60.4 to 100)
POD2	83.3 (58.3 to 100)	91.7 (68.75 to 100)
4-6 weeks	100 (83.3 to 100)	100 (100 to 100)
3 months	100 (100 to 100)	100 (100 to 100)
6 months	100 (100 to 100)	100 (100 to 100)
1 year	100 (100 to 100)	100 (100 to 100)

Control vs Treatment: p = 0.043, Wilcoxon (Mann-Whitney)
Control vs Treatment: p = 0.606, Wilcoxon (Mann-Whitney)
Control vs Treatment: p = 0.155, Wilcoxon (Mann-Whitney)

Population analysed: Patient with completed follow-up

Primary outcome: Degree of Dysphagia Patients Experience (Eating Duration)

Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Control n = 53	Treatment n = 56
Pre-operative	100 (100 to 100)	100 (100 to 100)
POD1	75 (25 to 93.75)	75 (37.5 to 100)
POD2	50 (18.75 to 87.5)	75 (37.5 to 100)
4-6 weeks	87.5 (43.75 to 100)	100 (75 to 100)
3 months	100 (75 to 100)	100 (87.5 to 100)
6 months	100 (87.5 to 100)	100 (100 to 100)
1 year	100 (87.5 to 100)	100 (100 to 100)

Control vs Treatment: p = 0.250, Wilcoxon (Mann-Whitney)
Control vs Treatment: p = 0.478, Wilcoxon (Mann-Whitney)
Control: p = 0.019, Wilcoxon (Mann-Whitney)

Population analysed: Patient with completed follow-up

Primary outcome: Degree of Dysphagia Patients Experience (Food Selection)

Time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Control n = 53	Treatment n = 56
Pre-operative	100 (100 to 100)	100 (100 to 100)
POD1	75 (37.5 to 93.75)	93.75 (50 to 100)
POD2	62.5 (25 to 100)	75 (62.5 to 100)
4-6 weeks	100 (75 to 100)	100 (75 to 100)
3 months	100 (100 to 100)	100 (100 to 100)
6 months	100 (100 to 100)	100 (100 to 100)
1 year	100 (100 to 100)	100 (100 to 100)

Control vs Treatment: p = 0.376, Wilcoxon (Mann-Whitney)
Control vs Treatment: p = 0.013, Wilcoxon (Mann-Whitney)
Control vs Treatment: p = 0.049, Wilcoxon (Mann-Whitney)

Population analysed: Patient with completed follow-up

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	3 of 53 (5.7%)	42 of 53 (79.2%)	0 of 53
Treatment	3 of 56 (5.4%)	46 of 56 (82.1%)	0 of 56

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Todd Albert, MD principal investigator

Hospital for Special Surgery, New York

Questions about this trial

What is this clinical trial studying?

A study testing Methylprednisolone Acetate and Hemostatic Matrix Kit in people with Cervical Disc Herniation and Cervical Degenerative Disc Disease, run by Hospital for Special Surgery, New York.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of Dysphagia Patients Experience (Burden) (time frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02539394.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.