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Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02773537
Recruitment Status : Completed
First Posted : May 16, 2016
Results First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Arthroplasty, Replacement, Knee
Interventions Drug: Femoral nerve catheter and sciatic nerve block
Drug: Adductor canal catheter and selective tibial block
Drug: Adductor canal catheter only
Enrollment 75
Recruitment Details Recruitment occurred between October 2015 and August 2016. Patients were approached for participation in the study during their pre-op medical clearance clinic appointment.
Pre-assignment Details A total of 107 patients undergoing primary TKA met initial eligibility criteria and were offered participation in the trial. 75 total subjects were randomized and considered enrolled to one of three arms of the study. 32 patients were excluded for various reasons prior to randomization.
Arm/Group Title Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Hide Arm/Group Description

Femoral nerve catheter and sciatic nerve block

Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter and selective tibial block

Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter only

Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Period Title: Overall Study
Started 25 25 25
Completed 25 24 21
Not Completed 0 1 4
Reason Not Completed
Lost to Follow-up             0             1             4
Arm/Group Title Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only Total
Hide Arm/Group Description

Femoral nerve catheter and sciatic nerve block

Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter and selective tibial block

Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter only

Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Total of all reporting groups
Overall Number of Baseline Participants 25 25 25 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 25 participants 75 participants
60.1  (6.1) 65.7  (9.5) 65.6  (6.8) 63.8  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
Female
15
  60.0%
11
  44.0%
11
  44.0%
37
  49.3%
Male
10
  40.0%
14
  56.0%
14
  56.0%
38
  50.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  28.0%
9
  36.0%
7
  28.0%
23
  30.7%
White
18
  72.0%
16
  64.0%
18
  72.0%
52
  69.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 25 participants 75 participants
25 25 25 75
Baseline VAS Pain Score   [1] 
Median (Full Range)
Unit of measure:  Score on a scale
Number Analyzed 25 participants 25 participants 25 participants 75 participants
5
(2 to 9)
6
(0 to 10)
6
(2 to 10)
6
(0 to 10)
[1]
Measure Description: Pain score on a scale of 0-10 with 0 being the least possible pain and 10 being the worst pain imaginable.
1.Primary Outcome
Title Pain Measurement Via VAS (Visual Analog Scale)
Hide Description The primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome.
Time Frame 48 hours after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Hide Arm/Group Description:

Femoral nerve catheter and sciatic nerve block

Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter and selective tibial block

Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter only

Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.11  (.43) 4.68  (.44) 4.36  (.42)
2.Secondary Outcome
Title Narcotic Requirements
Hide Description Narcotic dosages will be measured and reported as oral morphine milligram equivalents.
Time Frame 48 hours after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Hide Arm/Group Description:

Femoral nerve catheter and sciatic nerve block

Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter and selective tibial block

Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter only

Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Overall Number of Participants Analyzed 25 25 25
Mean (Inter-Quartile Range)
Unit of Measure: milligrams of morphine equivalents
90
(70 to 125)
107.5
(84.5 to 142.5)
107
(77.5 to 162.5)
3.Secondary Outcome
Title Functional Outcome Measures- Exstension/Knee Buckling
Hide Description Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. They will document the patient's ability to perform independent terminal knee extension and grade knee buckling with ambulation on a scale of 0-2 during each encounter. A grade of 0 indicates no knee buckling, 1 indicates slight buckling, and a grade of 2 represents knee buckling significant enough in the opinion of the physical therapist to require a knee immobilizer while ambulating. I higher score corresponds to a worse outcome. The numbers below in the outcome measure table are the number of patients who achieved terminal knee extension for had ANY knee buckling respectively.
Time Frame 1-2 days after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Hide Arm/Group Description:

Femoral nerve catheter and sciatic nerve block

Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter and selective tibial block

Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter only

Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Overall Number of Participants Analyzed 25 25 25
Measure Type: Number
Unit of Measure: number of participants
Terminal Knee Extension (Yes) (Post Op. Day 2) 13 15 22
Any Knee Buckling (Yes) (Post Op. Day 1) 20 7 8
Any Knee Buckling (Yes) (PPost Op. Day 2) 8 4 1
Terminal Knee Extension (YES)(Post Op Day 1) 10 16 20
4.Secondary Outcome
Title Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)
Hide Description Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #1, the therapist will calculate the Activity Measure for Post-Acute Care (AM-PAC) score. The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities,and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.
Time Frame Morning of post-op day 1 - 2 days after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Hide Arm/Group Description:

Femoral nerve catheter and sciatic nerve block

Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter and selective tibial block

Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter only

Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
15.0  (2.0) 16.5  (4.0) 16.0  (2.0)
5.Secondary Outcome
Title Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked
Hide Description Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document distance walked by the patient.
Time Frame Morning of post-op day 1 - 2 days after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Hide Arm/Group Description:

Femoral nerve catheter and sciatic nerve block

Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter and selective tibial block

Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter only

Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: Feet
80  (102) 155  (150) 160  (105)
6.Secondary Outcome
Title Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds
Hide Description Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document a timed up-and-go test (TUG).
Time Frame Morning of post-op day 1 - 2 days after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Hide Arm/Group Description:

Femoral nerve catheter and sciatic nerve block

Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter and selective tibial block

Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter only

Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: seconds
66.1  (32.0) 61.9  (29.6) 65.3  (39.3)
7.Secondary Outcome
Title Patient Reported Pain and Function Outcomes
Hide Description

Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.

Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20 and the max is 100.

Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).

Time Frame 6 Weeks after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Hide Arm/Group Description:

Femoral nerve catheter and sciatic nerve block

Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter and selective tibial block

Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter only

Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
KOOS Pain 63.3  (19.0) 57.8  (17.0) 62.6  (15.8)
KOOS Symptom 61.7  (21.8) 62.6  (16.9) 58.7  (13.2)
PROMIS 37.4  (4.76) 41.5  (6.35) 39.2  (6.42)
8.Secondary Outcome
Title Patient Reported Pain and Function Outcomes
Hide Description

Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.

Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20, the maximum is 100.

Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).

Time Frame 3 Months after Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Hide Arm/Group Description:

Femoral nerve catheter and sciatic nerve block

Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter and selective tibial block

Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter only

Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
KOOS Pain 66.8  (19.8) 72.6  (18.4) 70.5  (17.3)
KOOS Symptom 64.3  (19.0) 71.7  (12.9) 67.4  (15.8)
PROMIS 41.1  (6.92) 45.4  (7.17) 44.4  (6.04)
Time Frame 3 months post operatively
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Hide Arm/Group Description

Femoral nerve catheter and sciatic nerve block

Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter and selective tibial block

Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Adductor canal catheter only

Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

All-Cause Mortality
Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Femoral Nerve Catheter and Sciatic Nerve Block Adductor Canal Catheter and Selective Tibial Block Adductor Canal Catheter Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/25 (8.00%)      5/25 (20.00%)      2/25 (8.00%)    
Musculoskeletal and connective tissue disorders       
Arthrofibrosis requiring manipulation under anesthesia   1/25 (4.00%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Flexion Contracture   1/25 (4.00%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Transient thigh muscle spasms, anterior and posterior   0/25 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0
Prolonged wound drainage   0/25 (0.00%)  0 2/25 (8.00%)  2 0/25 (0.00%)  0
Transient posterior thigh burning   0/25 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0
Persistent decreased sensation, lateral heel Hemarthrosis   0/25 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0
Patellar Tendon rupture after Fall   0/25 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1
Pulmonary embolus   0/25 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Eric Bolin
Organization: Medical University of South Carolina
Phone: 843-792-2322
EMail: bolin@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02773537    
Other Study ID Numbers: Pro00042461
First Submitted: May 3, 2016
First Posted: May 16, 2016
Results First Submitted: August 9, 2018
Results First Posted: March 27, 2019
Last Update Posted: March 27, 2019