Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)
Study Details
Study Description
Brief Summary
Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia compared to intravenous steroids or a control group
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
Dysphagia is a common complication after ACDF. PSTS is also a natural sequela of ACDF and can lead to airway compromise among other complications. Previous studies have demonstrated that administration of intravenous methylprednisolone (1mg/kg) after anterior cervical spine surgery reduced the incidence of pharyngolaryngeal lesions as identified by nasofibroscopic examination. Lee et al. prospectively evaluated 50 patients and determined that local application of steroids in the retropharyngeal area following ACDF reduced PSTS and odynophagia as measured by the Visual Analogue Scale (VAS) and the Neck Disability Index (NDI) compared to a control group. Furthermore, there were no adverse events/reactions from local application of steroid on a gel foam sponge in the setting of anterior spinal surgery. There are no studies in the current literature that investigate the incidence of dysphagia with application of local steroids after ACDF, nor are there any studies that stratify the efficacy of local steroids compared to intravenous steroids. There is also no current spine literature that directly compares the efficacy of intravenous steroids versus local steroids in the incidence of dysphagia or dysphonia. Our study will be the first in the literature to assess the efficacy of local steroids in reducing the incidence of dysphagia after anterior cervical spine surgery, and as a result, may improve patient outcomes after ACDF.
Dysphagia and dysphonia are common complications after anterior cervical spine surgery. Despite their clinical importance, studies on the treatment and/or prevention of these complications are limited due to the lack of valid and reliable outcome measures. The majority of research is found in the otolaryngology literature and has focused on disease pathophysiology, diagnosis, and therapy.
The Bazaz score has been used in the spine literature to evaluate dysphagia after anterior cervical discectomy and fusion (ACDF). This is a subjective questionnaire that has not been validated in the literature. Additionally, new patient-centered outcome measures, the Eating Assessment Tool (EAT-10) and Voice Handicap Index (VHI-10) have recently been developed, and in addition to the Bazaz score, have been shown to have excellent validity and reliability in the ENT patient population. These instruments can be used to document the initial dysphagia or dysphonia severity and monitor the treatment response in people with a wide array of swallowing and voice disorders.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control group No steroid |
|
| Experimental: IV steroid 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate |
Drug: Decadron
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
|
| Experimental: Local steroid 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate |
Drug: Triamcinolone
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
|
Outcome Measures
Primary Outcome Measures
- Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op [baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year.]
Outcome measure used to measure the incidence and severity of postoperative trouble swallowing. Summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of difficulty or disability reported by the patient for the indicated activity; EAT-10 >3 = dysphagia & EAT-10 >15 = severe dysphagia
- Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op [baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year.]
Outcome measure used to measure the incidence and severity of postoperative trouble with hoarseness of voice; summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of disability or handicap reported by the patient. Reported as a percentage of patients in each group reporting an 'abnormal' VHI-10 score defined as a summative score >11
- Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op [Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year]
Outcome measure used to measure for neck pain that includes personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Summative scores for 10 questions (range 0-50) with each question scored 0-5 where higher scores for each question indicates greater extent of disability/difficulty for the associated activity. Reported as a mean percentage + standard deviation of difficulty/disability experienced by the patient.
- Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op [Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year; analyzed for all time points through 6 months post op]
Most commonly utilized pain scale; scored 0-10 with higher values indicating increased severity of pain experienced by the patient
- Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score [Evaluated at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year]
Outcome measure used to measure the incidence and severity of postoperative trouble swallowing
Eligibility Criteria
Criteria
Inclusion Criteria:
-
All patients undergoing ACDF (single or multi-level) for the treatment of cervical radiculopathy or myelopathy
-
All subjects must have given signed, informed consent prior to registration on study.
Exclusion Criteria:
-
Patients undergoing revision surgery, any operations for trauma, infection, tumor
-
Patients with general metabolic diseases such as rheumatoid arthritis, diabetes, chronic heart and renal diseases.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern Medicine Department of Orthopaedic Surgery | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
- Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24.
- Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. Review.
- Lee SH, Kim KT, Suk KS, Park KJ, Oh KI. Effect of retropharyngeal steroid on prevertebral soft tissue swelling following anterior cervical discectomy and fusion: a prospective, randomized study. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2286-92. doi: 10.1097/BRS.0b013e318237e5d0.
- McAfee PC, Cappuccino A, Cunningham BW, Devine JG, Phillips FM, Regan JJ, Albert TJ, Ahrens JE. Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial. J Spinal Disord Tech. 2010 Feb;23(1):1-8. doi: 10.1097/BSD.0b013e31819e2ab8.
- Pedram M, Castagnera L, Carat X, Macouillard G, Vital JM. Pharyngolaryngeal lesions in patients undergoing cervical spine surgery through the anterior approach: contribution of methylprednisolone. Eur Spine J. 2003 Feb;12(1):84-90. Epub 2002 Dec 4.
- Sanfilippo JA Jr, Lim MR, Jacoby SM, Laterra R, Harrop JS, Vaccaro AR, Hilibrand AS, Anderson DG, Albert TJ. "Normal" prevertebral soft tissue swelling following elective anterior cervical decompression and fusion. J Spinal Disord Tech. 2006 Aug;19(6):399-401.
- STU00085674
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Control Group | IV Steroid | Local Steroid |
|---|---|---|---|
| Arm/Group Description | No steroid | 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate | 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate |
| Period Title: Overall Study | |||
| STARTED | 24 | 27 | 29 |
| COMPLETED | 21 | 25 | 29 |
| NOT COMPLETED | 3 | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Control Group | IV Steroid | Local Steroid | Total |
|---|---|---|---|---|
| Arm/Group Description | No steroid | 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate | 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate | Total of all reporting groups |
| Overall Participants | 21 | 25 | 29 | 75 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
15
71.4%
|
20
80%
|
23
79.3%
|
58
77.3%
|
| >=65 years |
6
28.6%
|
5
20%
|
6
20.7%
|
17
22.7%
|
| Age (years) [Mean (Full Range) ] | ||||
| Mean (Full Range) [years] |
54
|
51.6
|
55.6
|
53.7
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
10
47.6%
|
11
44%
|
14
48.3%
|
35
46.7%
|
| Male |
11
52.4%
|
14
56%
|
15
51.7%
|
40
53.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
21
100%
|
25
100%
|
29
100%
|
75
100%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
21
100%
|
25
100%
|
29
100%
|
75
100%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
21
100%
|
25
100%
|
29
100%
|
75
100%
|
Outcome Measures
| Title | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op |
|---|---|
| Description | Outcome measure used to measure the incidence and severity of postoperative trouble swallowing. Summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of difficulty or disability reported by the patient for the indicated activity; EAT-10 >3 = dysphagia & EAT-10 >15 = severe dysphagia |
| Time Frame | baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team |
| Arm/Group Title | Control Group | IV Steroid | Local Steroid |
|---|---|---|---|
| Arm/Group Description | No steroid | 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate | 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate |
| Measure Participants | 21 | 25 | 29 |
| Baseline Dysphagia |
9.52
|
16.00
|
10.34
|
| Baseline Severe Dysphagia |
0
|
0
|
0
|
| 1 Day Post Op Dysphagia |
76.19
|
68.00
|
61.90
|
| 1 Day Post Op Severe Dysphagia |
38.09
|
32.00
|
17.85
|
| 2 wk. Post Op Dysphagia |
50.00
|
48.00
|
27.58
|
| 2 wk. Post Op Severe Dysphagia |
20.00
|
16.00
|
0.00
|
| 6 wk. Post Op Dysphagia |
38.09
|
34.78
|
17.24
|
| 6 wk. Post Op Severe Dysphagia |
28.57
|
0.00
|
0.00
|
| 3 mo. Post Op Dysphagia |
20.00
|
8.69
|
6.89
|
| 3 mo. Post Op Severe Dysphagia |
10.00
|
0.00
|
0.00
|
| 6 mo. Post Op Dysphagia |
21.05
|
8.33
|
13.79
|
| 6 mo. Post Op Severe Dysphagia |
0.00
|
0.00
|
0.00
|
| 1 yr. Post Op Dysphagia |
21.05
|
0.00
|
6.89
|
| 1 yr. Post Op Severe Dysphagia |
10.52
|
0.00
|
0.00
|
| Title | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op |
|---|---|
| Description | Outcome measure used to measure the incidence and severity of postoperative trouble with hoarseness of voice; summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of disability or handicap reported by the patient. Reported as a percentage of patients in each group reporting an 'abnormal' VHI-10 score defined as a summative score >11 |
| Time Frame | baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team |
| Arm/Group Title | Control Group | IV Steroid | Local Steroid |
|---|---|---|---|
| Arm/Group Description | No steroid | 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate | 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate |
| Measure Participants | 21 | 25 | 29 |
| Baseline Abnormal VHI-10 |
9.52
|
8.00
|
3.44
|
| 1 Day Post Op Abnormal VHI-10 |
4.76
|
4.00
|
3.57
|
| 2 wk. Post Op Abnormal VHI-10 |
10.00
|
20.00
|
0.00
|
| 6 wk. Post Op Abnormal VHI-10 |
9.52
|
8.69
|
3.44
|
| 3 mo. Post Op Abnormal VHI-10 |
10.00
|
4.34
|
0.00
|
| 6 mo. Post Op Abnormal VHI-10 |
10.53
|
8.33
|
3.44
|
| 1 yr. Post Op Abnormal VHI-10 |
10.53
|
8.33
|
0.00
|
| Title | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op |
|---|---|
| Description | Outcome measure used to measure for neck pain that includes personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Summative scores for 10 questions (range 0-50) with each question scored 0-5 where higher scores for each question indicates greater extent of disability/difficulty for the associated activity. Reported as a mean percentage + standard deviation of difficulty/disability experienced by the patient. |
| Time Frame | Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team |
| Arm/Group Title | Control Group | IV Steroid | Local Steroid |
|---|---|---|---|
| Arm/Group Description | No steroid | 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate | 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate |
| Measure Participants | 21 | 25 | 29 |
| Baseline NDI |
40
(19)
|
34
(18)
|
35
(19)
|
| 1 Day Post Op NDI |
27
(14)
|
28
(16)
|
27
(18)
|
| 2 wk. Post Op NDI |
31
(20)
|
24
(15)
|
20
(16)
|
| 6 wk. Post Op NDI |
23
(19)
|
21
(15)
|
24
(19)
|
| 3 mo. Post Op NDI |
14.6
(40)
|
11.1
(23.3)
|
10
(23.5)
|
| 6 mo. Post Op NDI |
23
(19)
|
21
(15)
|
24
(19)
|
| 1 yr. Post Op NDI |
22.2
(33.6)
|
4.0
(18)
|
6.0
(26)
|
| Title | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op |
|---|---|
| Description | Most commonly utilized pain scale; scored 0-10 with higher values indicating increased severity of pain experienced by the patient |
| Time Frame | Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year; analyzed for all time points through 6 months post op |
Outcome Measure Data
| Analysis Population Description |
|---|
| All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team |
| Arm/Group Title | Control Group | IV Steroid | Local Steroid |
|---|---|---|---|
| Arm/Group Description | No steroid | 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate | 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate |
| Measure Participants | 21 | 25 | 29 |
| VAS Pain Score (Baseline) |
8.0
|
8.0
|
7.0
|
| VAS Pain Score (1 Day Post Op) |
7.00
|
6.00
|
6.00
|
| VAS Pain Score (2 wk. Post Op) |
6.00
|
4.00
|
4.00
|
| VAS Pain Score (6 wk. Post Op) |
5.00
|
4.00
|
5.00
|
| VAS Pain Score (3 mo. Post Op) |
4.5
|
3.0
|
3.00
|
| VAS Pain Score (6 mo. Post Op) |
5.0
|
4.0
|
5.00
|
| VAS Pain Score (1 yr. Post Op) |
4.0
|
2.0
|
1.0
|
| Title | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score |
|---|---|
| Description | Outcome measure used to measure the incidence and severity of postoperative trouble swallowing |
| Time Frame | Evaluated at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team |
| Arm/Group Title | Control Group | IV Steroid | Local Steroid |
|---|---|---|---|
| Arm/Group Description | No steroid | 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate | 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate |
| Measure Participants | 21 | 25 | 29 |
| Baseline Bazaz Score (Mild or Greater) |
4.76
|
0.00
|
6.89
|
| Baseline Bazaz Score (Moderate-Severe) |
0.00
|
0.00
|
0.00
|
| 1 Day Post Op Bazaz Score (Mild or Greater) |
61.90
|
44.00
|
50.00
|
| 1 Day Post Op Bazaz Score (Moderate-Severe) |
33.33
|
24.00
|
7.14
|
| 2 wk. Post Op Bazaz Score (Mild or Greater) |
30.00
|
16.00
|
13.79
|
| 2 wk. Post Op Bazaz Score (Moderate-Severe) |
15.00
|
16.00
|
0.00
|
| 6 wk. Post Op Bazaz Score (Mild or Greater) |
28.57
|
17.39
|
6.89
|
| 6 wk. Post Op Bazaz Score (Moderate-Severe) |
23.80
|
8.69
|
0.00
|
| 3 mo. Post Op Bazaz Score (Mild or Greater) |
15.00
|
13.04
|
13.79
|
| 3 mo. Post Op Bazaz Score (Moderate-Severe) |
15.00
|
0.00
|
0.00
|
| 6 mo. Post Op Bazaz Score (Mild or Greater) |
15.78
|
8.33
|
13.79
|
| 6 mo. Post Op Bazaz Score (Moderate-Severe) |
5.26
|
0.00
|
0.00
|
| 1 yr. Post Op Bazaz Score (Mild or Greater) |
15.78
|
0.00
|
3.44
|
| 1 yr. Post Op Bazaz Score (Moderate-Severe) |
5.26
|
0.00
|
3.44
|
Adverse Events
| Time Frame | 1 year | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. | |||||
| Arm/Group Title | Control Group | IV Steroid | Local Steroid | |||
| Arm/Group Description | No steroid | 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate | 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate | |||
All Cause Mortality |
||||||
| Control Group | IV Steroid | Local Steroid | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Serious Adverse Events |
||||||
| Control Group | IV Steroid | Local Steroid | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Control Group | IV Steroid | Local Steroid | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Surabhi Bhatt |
|---|---|
| Organization | Northwestern University Department of Orthopaedic Surgery |
| Phone | 312-472-6024 |
| surabhi.bhatt@nm.org |
- STU00085674