Trial Outcomes & Findings for Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol (NCT NCT04042233)

NCT ID: NCT04042233

Last Updated: 2025-03-13

Results Overview

vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 23 participants
• Primary outcome timeframe: approximately 10 minutes before incision
• Results posted on: 2025-03-13

Participant Flow

Participant milestones

Measure	IV Administration of Vancomycin Standard IV vancomycin administration protocol. Standard IV administration of vancomycin: IV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).	IO Vancomycin 500mg in 250 mL NS Experimental Intraosseous administration protocol. Experimental Intraosseous vancomycin 500mg in 250 mL NS: 500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.
Overall Study STARTED	11	12
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	IV Administration of Vancomycin Standard IV vancomycin administration protocol. Standard IV administration of vancomycin: IV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).	IO Vancomycin 500mg in 250 mL NS Experimental Intraosseous administration protocol. Experimental Intraosseous vancomycin 500mg in 250 mL NS: 500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.
Overall Study 1st sample used for calibration of vancomycin tissue/bone concentration	1	0
Overall Study Protocol Violation	0	2

Baseline Characteristics

Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

Baseline characteristics by cohort

Measure	IV Administration of Vancomycin n=10 Participants Standard IV vancomycin administration protocol. Standard IV administration of vancomycin: IV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).	IO Vancomycin 500mg in 250 mL NS n=10 Participants Experimental Intraosseous administration protocol. Experimental Intraosseous vancomycin 500mg in 250 mL NS: 500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	68.51 years STANDARD_DEVIATION 5.99 • n=5 Participants	67.89 years STANDARD_DEVIATION 4.10 • n=7 Participants	68.31 years STANDARD_DEVIATION 4.81 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
The American Society of Anesthesiologists (ASA) physical status classification	2.6 units on a scale STANDARD_DEVIATION 0.52 • n=5 Participants	2.4 units on a scale STANDARD_DEVIATION 0.52 • n=7 Participants	2.5 units on a scale STANDARD_DEVIATION 0.51 • n=5 Participants
BMI	27.36 kg/m^2 STANDARD_DEVIATION 4.68 • n=5 Participants	27.85 kg/m^2 STANDARD_DEVIATION 4.88 • n=7 Participants	27.6 kg/m^2 STANDARD_DEVIATION 4.66 • n=5 Participants

PRIMARY outcome

Timeframe: approximately 10 minutes before incision

vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision.

Outcome measures

Measure	IV Group n=10 Participants IV group	IO Group n=10 Participants IO
Systemic Vancomycin Level - Start of Case	27.98 ug/mL Standard Deviation 13.67	0 ug/mL Standard Deviation 0

PRIMARY outcome

Timeframe: end of surgical case

Outcome measures

Measure	IV Group n=10 Participants IV group	IO Group n=10 Participants IO
Systemic Vancomycin Level - End of Case	21 ug/mL Standard Deviation 7.34	5.75 ug/mL Standard Deviation 2.86

PRIMARY outcome

Timeframe: intraoperative

vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.

Outcome measures

Measure	IV Group n=7 Participants IV group	IO Group n=7 Participants IO
Vancomycin Concentration of Pulvinar Soft Tissue	61.58 ug/mL Standard Deviation 46.64	71.79 ug/mL Standard Deviation 48.15

PRIMARY outcome

Timeframe: intraoperative

Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.

Outcome measures

Measure	IV Group n=10 Participants IV group	IO Group n=10 Participants IO
Vancomycin Concentration of Intramedullary Bone	33.93 ug/mL Standard Deviation 26.86	59.39 ug/mL Standard Deviation 28.43

SECONDARY outcome

Timeframe: at start of case within 15 minutes after incision

at start , soft tissue. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.

Outcome measures

Measure	IV Group n=10 Participants IV group	IO Group n=10 Participants IO
Soft Tissue Vancomycin Level - Start of Case	63.77 ug/mL Standard Deviation 33.70	69.08 ug/mL Standard Deviation 37.48

SECONDARY outcome

Timeframe: intraoperative

Intraoperative femur bone sample measured for vancomycin concentration (ug/mL). Vancomycin tissue concentration measured by high performance liquid chromatography.

Outcome measures

Measure	IV Group n=10 Participants IV group	IO Group n=10 Participants IO
Femur Vancomycin Concentration Level	20.90 ug/mL Standard Deviation 20.81	41.45 ug/mL Standard Deviation 29.92

SECONDARY outcome

Timeframe: intraoperative

Intra-operative Acetabulum bone vancomycin concentrations (ug/mL) measured by high performance liquid chromatography.

Outcome measures

Measure	IV Group n=10 Participants IV group	IO Group n=10 Participants IO
Acetabulum Vancomycin Level	67.97 ug/mL Standard Deviation 24.82	130.88 ug/mL Standard Deviation 45.40

SECONDARY outcome

Timeframe: From the administration of antibiotics perioperatively to 30 days post op.

Complications 30 days post surgery eg. infection.

Outcome measures

Measure	IV Group n=10 Participants IV group	IO Group n=10 Participants IO
30-Day Complications	3 Participants	0 Participants

SECONDARY outcome

Timeframe: From the administration of antibiotics perioperatively to 90 days post op.

Complications 90 days post surgery eg. infection

Outcome measures

Measure	IV Group n=10 Participants IV group	IO Group n=10 Participants IO
90-Day Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: right before wound closure is initiated at the end of the case

soft tissue taken at end of case, right before wound closure is initiated. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.

Outcome measures

Measure	IV Group n=10 Participants IV group	IO Group n=10 Participants IO
Soft Tissue Vancomycin Level - End of Case	57.14 ug/mL Standard Deviation 29.49	78.22 ug/mL Standard Deviation 26.25

Adverse Events

IV Group

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

IO Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	IV Group n=10 participants at risk IV group	IO Group n=10 participants at risk IO
Musculoskeletal and connective tissue disorders Fall	10.0% 1/10 • Number of events 1 • 90 days	0.00% 0/10 • 90 days
Gastrointestinal disorders Rectal Bleeding	10.0% 1/10 • Number of events 1 • 90 days	0.00% 0/10 • 90 days

Other adverse events

Measure	IV Group n=10 participants at risk IV group	IO Group n=10 participants at risk IO
Musculoskeletal and connective tissue disorders serosanguinous drainag	10.0% 1/10 • Number of events 8 • 90 days	0.00% 0/10 • 90 days

Additional Information

Thomas Sullivan

Houston Methodist Hospital

Phone: 2817254460

Email: tsullivan@houstonmethodist.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place