Trial Outcomes & Findings for Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty (NCT NCT01027195)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

140 participants

Primary outcome timeframe

daily during hospital stay (an expected average of 4 days)

Results posted on

2012-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Bipolar Radiofrequency Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery.	Standard Bovie Electrocautery Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
Overall Study STARTED	71	69
Overall Study COMPLETED	71	69
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bipolar Radiofrequency n=71 Participants Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery.	Standard Bovie Electrocautery n=69 Participants Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.	Total n=140 Participants Total of all reporting groups
Age Continuous	55.4 years STANDARD_DEVIATION 10.9 • n=5 Participants	55.7 years STANDARD_DEVIATION 11.0 • n=7 Participants	55.5 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	31 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Body-Mass Index Females	28.6 kg/m2 STANDARD_DEVIATION 7.1 • n=5 Participants	29.2 kg/m2 STANDARD_DEVIATION 6.1 • n=7 Participants	28.9 kg/m2 STANDARD_DEVIATION 6.6 • n=5 Participants
Body-Mass Index Males	29.4 kg/m2 STANDARD_DEVIATION 4.7 • n=5 Participants	30.4 kg/m2 STANDARD_DEVIATION 5.1 • n=7 Participants	29.9 kg/m2 STANDARD_DEVIATION 4.9 • n=5 Participants
Baseline Hemoglobin	14.6 g/dL STANDARD_DEVIATION 1.3 • n=5 Participants	14.2 g/dL STANDARD_DEVIATION 1.2 • n=7 Participants	14.4 g/dL STANDARD_DEVIATION 1.3 • n=5 Participants

PRIMARY outcome

Timeframe: daily during hospital stay (an expected average of 4 days)

Outcome measures

Outcome measures
Measure	Bipolar Radiofrequency n=71 Participants Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery.	Standard Bovie Electrocautery n=69 Participants Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
Number of Patients Managed With Blood Transfusion	15 participants	14 participants

SECONDARY outcome

Timeframe: daily during hospital stay (an expected average of 4 days)

Outcome measures

Outcome measures
Measure	Bipolar Radiofrequency n=71 Participants Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery.	Standard Bovie Electrocautery n=69 Participants Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
Number of Units Transfused	0.38 units of blood Standard Deviation 0.83	0.44 units of blood Standard Deviation 0.98

SECONDARY outcome

Timeframe: Intraoperative (day of surgery)

Outcome measures

Outcome measures
Measure	Bipolar Radiofrequency n=71 Participants Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery.	Standard Bovie Electrocautery n=69 Participants Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
Estimated Blood Loss	315.2 mL Standard Deviation 203.4	368.5 mL Standard Deviation 277.8

SECONDARY outcome

Timeframe: within 30 days before surgery (preop), day of hospital discharge

Change in hemoglobin level from baseline to the day of hospital discharge.

Outcome measures

Outcome measures
Measure	Bipolar Radiofrequency n=71 Participants Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery.	Standard Bovie Electrocautery n=69 Participants Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
Change in Hemoglobin Level	-5.4 g/dL Standard Deviation 1.6	-5.3 g/dL Standard Deviation 1.8

SECONDARY outcome

Timeframe: daily during hospital stay (an expected average of 4 days)

Sum of daily morphine-equivalent mg narcotic usage during hospital stay.

Outcome measures

Outcome measures
Measure	Bipolar Radiofrequency n=71 Participants Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery.	Standard Bovie Electrocautery n=69 Participants Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay	156.1 total morphine-equivalent mg Standard Deviation 130.2	164.9 total morphine-equivalent mg Standard Deviation 123.4

SECONDARY outcome

Timeframe: day of hospital discharge

Outcome measures

Outcome measures
Measure	Bipolar Radiofrequency n=71 Participants Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery.	Standard Bovie Electrocautery n=69 Participants Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
Length of Stay	3.3 days Standard Deviation 1.1	3.4 days Standard Deviation 1.6

SECONDARY outcome

Timeframe: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery

A scoring system used to evaluate the outcome after total hip replacement. Domains include pain (44 points), function (47 points), deformity (4 points), and range of motion (5 points). A total score is computed by summing the individual domain scores, with a maximum of 100 points. Higher values represent better outcomes. A total Harris Hip Score below 70 points is generally considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent.

Outcome measures

Outcome measures
Measure	Bipolar Radiofrequency n=71 Participants Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery.	Standard Bovie Electrocautery n=69 Participants Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
Harris Hip Score (Outcome Score) 12 Weeks Postoperative	92.8 points on a scale Standard Deviation 8.2	95.1 points on a scale Standard Deviation 5.4
Harris Hip Score (Outcome Score) Preoperative	59.0 points on a scale Standard Deviation 12.2	60.4 points on a scale Standard Deviation 11.6
Harris Hip Score (Outcome Score) 4 Weeks Postoperative	78.4 points on a scale Standard Deviation 9.8	78.4 points on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery

A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing "no pain" and 10 representing "unbearable pain." Thus, in this context, lower values represent better outcomes.

Outcome measures

Outcome measures
Measure	Bipolar Radiofrequency n=71 Participants Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery.	Standard Bovie Electrocautery n=69 Participants Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
Pain Score Scale Preoperative	6.2 points on a scale Standard Deviation 2.2	6.4 points on a scale Standard Deviation 2.0
Pain Score Scale 4 Weeks Postoperative	1.7 points on a scale Standard Deviation 1.7	1.7 points on a scale Standard Deviation 1.8
Pain Score Scale 12 Weeks Postoperative	1.2 points on a scale Standard Deviation 1.7	0.9 points on a scale Standard Deviation 1.2

Adverse Events

Bipolar Radiofrequency

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard Bovie Electrocautery

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bipolar Radiofrequency n=71 participants at risk Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery.	Standard Bovie Electrocautery n=69 participants at risk Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
Infections and infestations Deep Infection	0.00% 0/71	1.4% 1/69 • Number of events 1
Cardiac disorders Coronary Ischemic Event	1.4% 1/71 • Number of events 1	1.4% 1/69 • Number of events 1
Vascular disorders Deep-Vein Thrombosis	0.00% 0/71	1.4% 1/69 • Number of events 1
Vascular disorders Pulmonary Embolism	1.4% 1/71 • Number of events 2	1.4% 1/69 • Number of events 1

Additional Information

Wael K Barsoum, MD

The Cleveland Clinic

Phone: 216-444-7515

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place