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

Joint Implant Surgeons, Inc.

Status: Completed

Conditions: Osteoarthritis, Hip; Hip Dislocation, Congenital; Osteonecrosis; Joint Deformities, Acquired; Arthritis, Rheumatoid

Treatments: Device: Aquamantys; Device: standard electrocautery (Bovie)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01583465

20091312

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Aquamantys Malleable Bipolar Sealer

Experimental group

Description:

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.

Treatment:

Device: Aquamantys

Standard Treatment

Active Comparator group

Description:

100 patients randomly assigned will undergo primary total hip arthroplasty via the anterior supine intermuscular approach performed with the assistance of standard electrocautery.

Treatment:

Device: standard electrocautery (Bovie)