Trial Outcomes & Findings for The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery (NCT NCT00990288)

NCT ID: NCT00990288

Last Updated: 2017-12-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 196 participants
• Primary outcome timeframe: preoperatively and on the day of surgery
• Results posted on: 2017-12-12

Participant Flow

Inclusion Criteria: 1)Diagnosis of knee arthritis in patients medically suitable to undergo unilateral TKA. Pre-operative Exclusion Criteria: 1. Known allergies to products of bovine origin. 2. History of bleeding disorders. 3. Pre- or peri-operative complication.

Participant milestones

Measure	Hemostatic Matrix 2 vials of Floseal applied once at the end of surgery	Control No intervention.
Overall Study STARTED	97	99
Overall Study COMPLETED	97	99
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery

Baseline characteristics by cohort

Measure	Hemostatic Matrix n=97 Participants 2 vials of Floseal applied once at the end of surgery	Control n=99 Participants No intervention.	Total n=196 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	20 Participants n=5 Participants	73 Participants n=7 Participants	93 Participants n=5 Participants
Age, Categorical >=65 years	77 Participants n=5 Participants	26 Participants n=7 Participants	103 Participants n=5 Participants
Age, Continuous	72.78 years STANDARD_DEVIATION 8.90 • n=5 Participants	70.40 years STANDARD_DEVIATION 10.47 • n=7 Participants	71.58 years STANDARD_DEVIATION 9.77 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	71 Participants n=7 Participants	136 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment United States	97 participants n=5 Participants	99 participants n=7 Participants	196 participants n=5 Participants

PRIMARY outcome

Timeframe: preoperatively and on the day of surgery

Population: All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons

Outcome measures

Measure	Hemostatic Matrix n=96 Participants 2 vials of Floseal applied once at the end of surgery	Control n=98 Participants No intervention.
Change in Hemoglobin on Day 0 Compared to Preoperatively	-1.277 g/dL Standard Deviation .880	-1.241 g/dL Standard Deviation .883

PRIMARY outcome

Timeframe: preoperatively and day of surgery

Population: All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis.

Outcome measures

Measure	Hemostatic Matrix n=96 Participants 2 vials of Floseal applied once at the end of surgery	Control n=98 Participants No intervention.
Change in Hemoglobin on Day 0 Compared to Preoperatively	-4.484 g/L Standard Deviation 2.637	-4.305 g/L Standard Deviation 2.682

PRIMARY outcome

Timeframe: preoperatively and one day after surgery

Population: All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons

Outcome measures

Measure	Hemostatic Matrix n=92 Participants 2 vials of Floseal applied once at the end of surgery	Control n=94 Participants No intervention.
Change in Hemoglobin On Day 1 Compared to Preoperatively	-1.528 g/dL Standard Deviation 1.132	-1.816 g/dL Standard Deviation 1.168

PRIMARY outcome

Timeframe: preoperatively and 1 day after surgery

Population: All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons

Outcome measures

Measure	Hemostatic Matrix n=92 Participants 2 vials of Floseal applied once at the end of surgery	Control n=94 Participants No intervention.
Change in Hematocrit on Day 1 Compared to Preoperatively	-5.075 g/L Standard Deviation 3.298	-5.749 g/L Standard Deviation 3.652

PRIMARY outcome

Timeframe: preoperatively and two days after surgery

Population: All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.

Outcome measures

Measure	Hemostatic Matrix n=95 Participants 2 vials of Floseal applied once at the end of surgery	Control n=98 Participants No intervention.
Change in Hemoglobin on Day 2 Compared to Preoperatively	-2.265 g/dL Standard Deviation 1.443	-2.359 g/dL Standard Deviation 1.246

PRIMARY outcome

Timeframe: preoperatively and two days after surgery

Population: All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons

Outcome measures

Measure	Hemostatic Matrix n=95 Participants 2 vials of Floseal applied once at the end of surgery	Control n=98 Participants No intervention.
Change in Hematocrit on Day 2 Compared to Preoperatively	-7.013 g/L Standard Deviation 4.183	-7.418 g/L Standard Deviation 3.904

PRIMARY outcome

Timeframe: 24 hours postoperatively

Population: Drain output at 24 hours was recorded for all patients.

Outcome measures

Measure	Hemostatic Matrix n=97 Participants 2 vials of Floseal applied once at the end of surgery	Control n=99 Participants No intervention.
Drain Output	711 mL Standard Deviation 287	702 mL Standard Deviation 314.7

PRIMARY outcome

Timeframe: three days postoperatively

Outcome measures

Measure	Hemostatic Matrix n=93 Participants 2 vials of Floseal applied once at the end of surgery	Control n=96 Participants No intervention.
Autologous Amount of Transfusion	.828 units of blood Standard Deviation .746	.854 units of blood Standard Deviation .754

PRIMARY outcome

Timeframe: three days postoperatively

Outcome measures

Measure	Hemostatic Matrix n=95 Participants 2 vials of Floseal applied once at the end of surgery	Control n=95 Participants No intervention.
Homologous Amount of Transfusion	.247 units of blood Standard Deviation .525	.337 units of blood Standard Deviation .738

SECONDARY outcome

Timeframe: 3days postoperatively

Population: Patients whose range of motion at 3 day followup appointment was taken were included in analysis.

Outcome measures

Measure	Hemostatic Matrix n=97 Participants 2 vials of Floseal applied once at the end of surgery	Control n=97 Participants No intervention.
Range of Motion on Day 3	67.88 degrees Standard Deviation 14.54	68.96 degrees Standard Deviation 16.01

SECONDARY outcome

Timeframe: 3 days postoperatively

Population: All patients whose pain score was collected were included in analysis.

A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured.

The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.

Outcome measures

Measure	Hemostatic Matrix n=96 Participants 2 vials of Floseal applied once at the end of surgery	Control n=98 Participants No intervention.
Visual Analog Pain Scale on Day 3	2.99 points on visual analog pain scale Standard Deviation 2.311	2.78 points on visual analog pain scale Standard Deviation 2.44

SECONDARY outcome

Timeframe: 6 weeks postoperatively

Population: Patients whose range of motion at 6-week followup appointment was taken were included in analysis.

Outcome measures

Measure	Hemostatic Matrix n=83 Participants 2 vials of Floseal applied once at the end of surgery	Control n=86 Participants No intervention.
Range of Motion at Six Weeks	111.41 degrees Standard Deviation 14.25	112.97 degrees Standard Deviation 12.92

SECONDARY outcome

Timeframe: 6 weeks postoperatively

Population: Patients whose pain level at 6-week followup appointment was taken were included in analysis.

A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured.

The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.

Outcome measures

Measure	Hemostatic Matrix n=90 Participants 2 vials of Floseal applied once at the end of surgery	Control n=88 Participants No intervention.
Visual Analog Pain Scale at 6 Weeks	2.753 points on visual analog pain scale Standard Deviation 2.09	2.91 points on visual analog pain scale Standard Deviation 2.17

Adverse Events

Hemostatic Matrix

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hemostatic Matrix n=97 participants at risk 2 vials of Floseal applied once at the end of surgery	Control n=99 participants at risk No intervention.
Skin and subcutaneous tissue disorders Cellulitis	1.0% 1/97 • Number of events 1	1.0% 1/99 • Number of events 1
Vascular disorders Deep Venous Thromboses	1.0% 1/97 • Number of events 1	1.0% 1/99 • Number of events 1
Skin and subcutaneous tissue disorders Suture Abscess with Cellulitis	1.0% 1/97 • Number of events 1	1.0% 1/99 • Number of events 1
Surgical and medical procedures Manipulation Under Anesthesia Needed to Achieve Improved Range of Motion	2.1% 2/97 • Number of events 2	2.0% 2/99 • Number of events 2
Gastrointestinal disorders Paralytic Ileus	0.00% 0/97	1.0% 1/99 • Number of events 1

Additional Information

Mark P. Figgie MD

Hospital for Special Surgery

Phone: 212-606-1932

Email: figgiem@hss.edu

Results disclosure agreements

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