Trial Outcomes & Findings for Oral Versus Intravenous Tranexamic Acid (NCT NCT04089865)

Last Updated: 2024-12-27

Results Overview

Calculated Blood loss (CBL) measured in mL, measured at baseline (before surgery) and in the post-operative care unit (after surgery). The following formula was used CBL = BV × (HctPre - HctPost), where BV = (k1 × H3) + (k2 × W) + k3. The variables for the formula are as followed: CBL: Calculated blood loss BV: Blood volume at baseline HctPre: Haematocrit before surgery HctPost: Haematocrit after surgery H: Patient height in meters W: Patient weight in kilograms Although measured at two time points (before and after surgery), the calculated value from those two time points is average across all participants and reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

400 participants

Primary outcome timeframe

post-operative day 0

Results posted on

2024-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Total Hip Arthroplasty - Oral TXA 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Total Hip Arthroplasty - Intravenous TXA 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Total Knee Arthroplasty - Oral TXA 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Total Knee Arthroplasty - Intravenous TXA 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
Overall Study STARTED	100	100	100	100
Overall Study COMPLETED	98	98	93	98
Overall Study NOT COMPLETED	2	2	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Hip Arthroplasty - Oral TXA 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Total Hip Arthroplasty - Intravenous TXA 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Total Knee Arthroplasty - Oral TXA 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Total Knee Arthroplasty - Intravenous TXA 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
Overall Study Withdrawal by Subject	2	2	7	2

Baseline Characteristics

Oral Versus Intravenous Tranexamic Acid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Hip Arthroplasty - Oral TXA n=98 Participants 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Total Hip Arthroplasty - Intravenous TXA n=98 Participants 100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Total Knee Arthroplasty - Oral TXA n=93 Participants 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Total Knee Arthroplasty - Intravenous TXA n=98 Participants 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Total n=387 Participants Total of all reporting groups
Age, Continuous	63.84 years STANDARD_DEVIATION 9.14 • n=5 Participants	65.12 years STANDARD_DEVIATION 7.32 • n=7 Participants	66 years STANDARD_DEVIATION 7.57 • n=5 Participants	65.89 years STANDARD_DEVIATION 7.28 • n=4 Participants	65.2 years STANDARD_DEVIATION 7.88 • n=21 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	42 Participants n=7 Participants	56 Participants n=5 Participants	56 Participants n=4 Participants	209 Participants n=21 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	56 Participants n=7 Participants	37 Participants n=5 Participants	42 Participants n=4 Participants	178 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	31 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=5 Participants	92 Participants n=7 Participants	85 Participants n=5 Participants	89 Participants n=4 Participants	356 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	21 Participants n=21 Participants
Race (NIH/OMB) White	92 Participants n=5 Participants	87 Participants n=7 Participants	75 Participants n=5 Participants	81 Participants n=4 Participants	335 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	22 Participants n=21 Participants
Region of Enrollment United States	98 participants n=5 Participants	98 participants n=7 Participants	93 participants n=5 Participants	98 participants n=4 Participants	387 participants n=21 Participants
American Society of Anesthesiology Status ASA Level I	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants
American Society of Anesthesiology Status ASA Level II	82 Participants n=5 Participants	86 Participants n=7 Participants	76 Participants n=5 Participants	84 Participants n=4 Participants	328 Participants n=21 Participants
American Society of Anesthesiology Status ASA Level III	13 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants	11 Participants n=4 Participants	45 Participants n=21 Participants
American Society of Anesthesiology Status Unknown - ASA level missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Body Mass Index, kg/m^2 Mean (Standard Deviation) Unit of measure: Kg/m^2	28.7 kg/m^2 STANDARD_DEVIATION 5.1 • n=5 Participants	29.6 kg/m^2 STANDARD_DEVIATION 4.3 • n=7 Participants	29.4 kg/m^2 STANDARD_DEVIATION 4.38 • n=5 Participants	30.8 kg/m^2 STANDARD_DEVIATION 5.1 • n=4 Participants	29.62 kg/m^2 STANDARD_DEVIATION 4.74 • n=21 Participants

PRIMARY outcome

Timeframe: post-operative day 0

Outcome measures

Outcome measures
Measure	Oral Tranexamic Acid (TXA) Total Hip Arthroplasty n=89 Participants 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty n=90 Participants 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Oral Tranexamic Acid (TXA) Total Knee Arthroplasty n=90 Participants 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty n=94 Participants 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
Calculated Blood Loss	842 CBL (ml) Standard Deviation 328	860 CBL (ml) Standard Deviation 313	799 CBL (ml) Standard Deviation 334	878 CBL (ml) Standard Deviation 348

SECONDARY outcome

Timeframe: From Post-Operative Day 0 to Post-Operative Day 2

To assess how many participants required a blood transfusion during their hospital stay. This will be measured in binary responses (yes/no).

Outcome measures

Outcome measures
Measure	Oral Tranexamic Acid (TXA) Total Hip Arthroplasty n=89 Participants 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty n=90 Participants 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Oral Tranexamic Acid (TXA) Total Knee Arthroplasty n=90 Participants 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty n=96 Participants 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
Transfusion During Hospital Stay	0 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: From 48-72 hours after surgery

Time to discharge from physical therapy (in minutes)

Outcome measures

Outcome measures
Measure	Oral Tranexamic Acid (TXA) Total Hip Arthroplasty n=87 Participants 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty n=87 Participants 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Oral Tranexamic Acid (TXA) Total Knee Arthroplasty n=89 Participants 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty n=92 Participants 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
Time to Discharge From Physical Therapy	2091.33 minutes Standard Deviation 1203.17	1914.45 minutes Standard Deviation 1055.47	2244.55 minutes Standard Deviation 1327.44	2285.09 minutes Standard Deviation 1499.37

SECONDARY outcome

Timeframe: After surgery to the time discharged from hospital (estimated 48-72 hours after surgery)

Hospital length of stay (in minutes)

Outcome measures

Outcome measures
Measure	Oral Tranexamic Acid (TXA) Total Hip Arthroplasty n=98 Participants 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty n=98 Participants 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Oral Tranexamic Acid (TXA) Total Knee Arthroplasty n=93 Participants 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty n=97 Participants 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
Length of Stay	2551.89 minutes Standard Deviation 1554.4	2138.6 minutes Standard Deviation 1126.71	2692.98 minutes Standard Deviation 1508.65	2852.55 minutes Standard Deviation 1511.05

Adverse Events

Oral Tranexamic Acid (TXA) Total Hip Arthroplasty

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Oral Tranexamic Acid (TXA) Total Knee Arthroplasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral Tranexamic Acid (TXA) Total Hip Arthroplasty n=89 participants at risk 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty n=90 participants at risk 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Oral Tranexamic Acid (TXA) Total Knee Arthroplasty n=90 participants at risk 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty n=96 participants at risk 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
Vascular disorders CVA, cerebrovascular accident	0.00% 0/89 • From enrollment through study completion, an average of 1 week Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse serious events were assessed over the course of the patient's participation in the research study.	1.1% 1/90 • From enrollment through study completion, an average of 1 week Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse serious events were assessed over the course of the patient's participation in the research study.	0.00% 0/90 • From enrollment through study completion, an average of 1 week Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse serious events were assessed over the course of the patient's participation in the research study.	0.00% 0/96 • From enrollment through study completion, an average of 1 week Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse serious events were assessed over the course of the patient's participation in the research study.

Other adverse events

Other adverse events
Measure	Oral Tranexamic Acid (TXA) Total Hip Arthroplasty n=89 participants at risk 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty n=90 participants at risk 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Oral Tranexamic Acid (TXA) Total Knee Arthroplasty n=90 participants at risk 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.	Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty n=96 participants at risk 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
Blood and lymphatic system disorders Complications	5.6% 5/89 • From enrollment through study completion, an average of 1 week Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse serious events were assessed over the course of the patient's participation in the research study.	2.2% 2/90 • From enrollment through study completion, an average of 1 week Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse serious events were assessed over the course of the patient's participation in the research study.	0.00% 0/90 • From enrollment through study completion, an average of 1 week Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse serious events were assessed over the course of the patient's participation in the research study.	2.1% 2/96 • From enrollment through study completion, an average of 1 week Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse serious events were assessed over the course of the patient's participation in the research study.

Additional Information

Stavros G. Memtsoudis, MD, PhD, MBA

Hospital for Special Surgery

Phone: (212) 606-1206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place