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

This study has been completed.
Sponsor:
Collaborator:
Salient Surgical Technologies
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01027195
First received: December 3, 2009
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Hip Arthritis
Device: Bipolar Radiofrequency (Aquamantys 6.0)
Device: Standard Bovie Electrocautery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Number of Patients Managed With Blood Transfusion [ Time Frame: daily during hospital stay (an expected average of 4 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Units Transfused [ Time Frame: daily during hospital stay (an expected average of 4 days) ] [ Designated as safety issue: Yes ]
  • Estimated Blood Loss [ Time Frame: Intraoperative (day of surgery) ] [ Designated as safety issue: Yes ]
  • Change in Hemoglobin Level [ Time Frame: within 30 days before surgery (preop), day of hospital discharge ] [ Designated as safety issue: Yes ]
    Change in hemoglobin level from baseline to the day of hospital discharge.

  • Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay [ Time Frame: daily during hospital stay (an expected average of 4 days) ] [ Designated as safety issue: Yes ]
    Sum of daily morphine-equivalent mg narcotic usage during hospital stay.

  • Length of Stay [ Time Frame: day of hospital discharge ] [ Designated as safety issue: Yes ]
  • Harris Hip Score (Outcome Score) [ Time Frame: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery ] [ Designated as safety issue: Yes ]
    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.

  • Pain Score Scale [ Time Frame: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 140
Study Start Date: August 2006
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027195

Sponsors and Collaborators
The Cleveland Clinic
Salient Surgical Technologies
Investigators
Principal Investigator: Wael K Barsoum, MD The Cleveland Clinic
  More Information

Publications:
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01027195     History of Changes
Obsolete Identifiers: NCT01448967
Other Study ID Numbers: 06-615
Study First Received: December 3, 2009
Results First Received: August 29, 2012
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014