Efficacy of Aquamantys for Reducing Transfusions With Anterior Supine Intermuscular Approach Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Osteoarthritis, Hip; Joint Deformities, Acquired; Hip Dislocation, Congenital; Osteonecrosis; Arthritis, Rheumatoid
• Interventions: Device: Aquamantys; Device: standard electrocautery (Bovie)

• Registration Number: NCT01583465
• Lead Sponsor: Joint Implant Surgeons, Inc.

Brief Summary

The purpose of this study is to establish whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.

Detailed Description

To establish in a randomized, blinded study whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing based on early collected data. Data will be analyzed using StatsDirect in standard fashion to elucidate any difference between control and treatment groups. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-04
• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-23
• Last Update Submitted: 2012-04-23
• Study First Posted: 2012-04-24
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Undergoing primary unilateral total hip arthroplasty via the anterior supine intermuscular approach
• Patient is willing and able to complete all follow-up visits at 6 weeks and 1 year

Exclusion Criteria

• Patients with pre-existing known coagulopathy
• Patients on chronic Coumadin (Warfarin) therapy
• Patients receiving erythropoietin therapy for anemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aquamantys Malleable Bipolar Sealer	Aquamantys	In 100 patients randomly assigned, primary total hip arthroplasty via an anterior supine intermuscular approach will be performed with the assistance of the Aquamantys Malleable Bipolar Sealer with Light.
Standard Treatment	standard electrocautery (Bovie)	100 patients randomly assigned will undergo primary total hip arthroplasty via the anterior supine intermuscular approach performed with the assistance of standard electrocautery.

Primary Outcome Measures

Name	Time	Method
Perioperative Change in Hemoglobin Level	From up to 30 days preoperative through postoperative day 1	All patients will undergo routine lab work perioperatively. No additional studies will be necessary for this protocol. Hemoglobin level will be first measured preoperatively at the time of preadmission testing, which must be performed not more than 30 days prior to surgery, and then measured on postoperative day one. The two levels will be compared to assess the decrease in hemoglobin level resulting from the surgical intervention.
Perioperative Blood Transfusion Requirement	From the beginning of surgical intervention to hospital discharge, which averages 2 days and may be up to 1 week postoperative	Perioperative blood transfusion requirements will be recorded, including transfusions administered during the surgical intervention and throughout the acute hospital stay.
Perioperative Blood Loss	From beginning of surgical intervention through hospital discharge, which averages 2 days and may be up to 1 week	Anesthesia and nursing records will be monitored for blood loss intraoperatively, and postoperatively via drain output. Drains will be pulled daily at 0600 and measured.

Secondary Outcome Measures

Name	Time	Method
The development of complications in the wound, either as an inpatient or after discharge	Wound evaluations will occur each postoperative day in hospital (average 2 days and up to 1 week), at 6 weeks, and 1 year.	Wound care will be evaluated by a designee who will be blinded to the randomization. Wound will be evaluated for drainage, erythema, and ecchymosis. Additionally, the wound healing will be scored as: Healing better than expected, As expected, or Worse than expected. Wound evaluations will occur each postoperative day in hospital (average 2 days), at 6 weeks, and 1 year.
Length of stay	From admission through hospital discharge (average 2 days, up to 1 week)	Length of acute hospital stay will be recorded.

Trial Locations

Locations (1)

Joint Implant Surgeons, Inc.; 🇺🇸 New Albany, Ohio, United States