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

NeuroTherapia, Inc.

Status and phase: Completed; Phase 4

Conditions: Hip Arthritis

Treatments: Device: Standard Bovie Electrocautery; Device: Bipolar Radiofrequency (Aquamantys 6.0)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01027195

06-615

Details and patient eligibility

About

The present prospective, single-center, clinical trial is designed to evaluate the hemostatic efficacy of the hemostatic sealer Aquamantys 6.0™ in patients managed with total hip arthroplasty (THA). It is hypothesized that Aquamantys 6.0™ can improve hemostasis following total hip arthroplasty. Comparison of the functional and clinical results between THA patients having been exposed to Aquamantys 6.0™ versus a control group will be analyzed using several outcome measures including the Harris Hip Score and a pain scale. The primary variable of interest is transfusion requirements - specifically, number of patients managed with blood transfusion during the hospital stay after surgery. However, of secondary interest will be: 1) number of units transfused, 2) estimated intraoperative total blood loss, 3) change in pre- and post-operative hemoglobin levels, 4) total narcotic usage during hospital stay, 5) length of stay, 6) functional and pain outcomes (Harris Hip Score and Pain Scale), and 7) adverse events.

Enrollment: 140 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 - 85 years
• Sex: Both male and female will be included. The male-to-female ratio will depend upon the patient population.
• Stable Health: At the time of surgery based on physical examination and medical history.
• Patient exhibited preoperative radiographic evidence of joint degeneration consistent with THA that could not have been treated in non-operative fashion.
• Patient had severe hip pain and disability due to degenerative joint disease.
• Patient or patient's legal representative has signed the Informed Consent form. The patient is capable of making informed decisions regarding his/her healthcare.

Exclusion criteria

• Patients with history of cardiac disease, liver disease or renal disease. Severe cardiac disease, liver disease and renal dysfunction can confound different parameters within this study. Patients with decreased cardiac function from prior myocardial infarction, cardiomyopathy or congestive heart failure will likely require transfusions with packed red blood cells at lower thresholds relative to healthy counterparts for cardioprotection. Therefore, patients with a prior history of myocardial infarction, cardiomyopathy, congestive heart failure or other significant cardiac history will be excluded from this study. In addition, patients with liver dysfunction from cirrhosis or hepatitis may have impaired production of factors in the clotting cascade which may make these individuals more prone to bleed, especially with the use of anticoagulants such as lovenox. For this reason, these patients will also be excluded from this study. Finally, individuals with renal dysfunction will have decreased creatinine clearance, which may artificially elevate the levels of lovenox, thereby promoting bleeding. In addition, individuals with severe renal disease may also have associated anemia which would complicate the transfusion threshold. For this reason, individuals with chronic renal failure, diabetic nephropathy, or decreased creatinine clearance will be excluded from this study.
• Patients predonating autologous blood.
• Patients with preoperative hemoglobin level less than 11.5 g/dL or a hematocrit less than 35%. Patients with a preoperative platelet count of less than 100,000.
• Patients undergoing bilateral or revision surgery.
• Evidence of bleeding or metabolic - based hemolytic disorder (hemophilia or anticoagulation use)
• Previous history of infection in the affected joint.
• Peripheral vascular disease.
• Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or mental handicap, etc.
• Patients whose personal beliefs exclude the use of blood transfusions (example: Jehovah's witness).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups, including a placebo group

Standard Bovie Electrocautery

Placebo Comparator group

Description:

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.

Treatment:

Device: Standard Bovie Electrocautery

Bipolar Radiofrequency

Experimental group

Description:

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.

Treatment:

Device: Bipolar Radiofrequency (Aquamantys 6.0)