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

• ClinicalTrials.gov Identifier: NCT01027195
• Recruitment Status: Completed
• First Posted: December 7, 2009
• Results First Posted: November 29, 2012
• Last Update Posted: November 29, 2012
• Sponsor: The Cleveland Clinic
• Collaborator: Salient Surgical Technologies
• Information provided by (Responsible Party): The Cleveland Clinic

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hip Arthritis	Device: Bipolar Radiofrequency (Aquamantys 6.0); Device: Standard Bovie Electrocautery	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty
• Study Start Date: August 2006
• Actual Primary Completion Date: April 2009
• Actual Study Completion Date: June 2009

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 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.	Device: Standard Bovie Electrocautery
Experimental: 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.	Device: Bipolar Radiofrequency (Aquamantys 6.0); Other Name: Aquamantys 6.0

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Managed With Blood Transfusion [ Time Frame: daily during hospital stay (an expected average of 4 days) ]

Secondary Outcome Measures :

1. Number of Units Transfused [ Time Frame: daily during hospital stay (an expected average of 4 days) ]
2. Estimated Blood Loss [ Time Frame: Intraoperative (day of surgery) ]
3. Change in Hemoglobin Level [ Time Frame: within 30 days before surgery (preop), day of hospital discharge ]
   Change in hemoglobin level from baseline to the day of hospital discharge.
4. Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay [ Time Frame: daily during hospital stay (an expected average of 4 days) ]
   Sum of daily morphine-equivalent mg narcotic usage during hospital stay.
5. Length of Stay [ Time Frame: day of hospital discharge ]
6. Harris Hip Score (Outcome Score) [ Time Frame: 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.
7. Pain Score Scale [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Sponsors and Collaborators

The Cleveland Clinic

Salient Surgical Technologies

Investigators

• Principal Investigator: Wael K Barsoum, MD; The Cleveland Clinic

More Information

Publications of Results:

Barsoum WK, Klika AK, Murray TG, Higuera C, Lee HH, Krebs VE. Prospective randomized evaluation of the need for blood transfusion during primary total hip arthroplasty with use of a bipolar sealer. J Bone Joint Surg Am. 2011 Mar 16;93(6):513-8. doi: 10.2106/JBJS.J.00036.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01027195
• Obsolete Identifiers: NCT01448967
• Other Study ID Numbers: 06-615
• First Posted: December 7, 2009
• Results First Posted: November 29, 2012
• Last Update Posted: November 29, 2012
• Last Verified: October 2012

Additional relevant MeSH terms:

Arthritis; Joint Diseases; Musculoskeletal Diseases