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

Hip Arthritis Clinical Trial

— Hip  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027195
• Other study ID #: 06-615
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2009
• Last updated: October 30, 2012
• Start date: August 2006
• Est. completion date: June 2009

Study information

• Verified date: October 2012
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01448967

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Arthritis

Intervention

Device:
• Bipolar Radiofrequency (Aquamantys 6.0)

• Standard Bovie Electrocautery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Salient Surgical Technologies

References & Publications (1)

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: 10.21 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Managed With Blood Transfusion		daily during hospital stay (an expected average of 4 days)	Yes
Secondary	Number of Units Transfused		daily during hospital stay (an expected average of 4 days)	Yes
Secondary	Estimated Blood Loss		Intraoperative (day of surgery)	Yes
Secondary	Change in Hemoglobin Level	Change in hemoglobin level from baseline to the day of hospital discharge.	within 30 days before surgery (preop), day of hospital discharge	Yes
Secondary	Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay	Sum of daily morphine-equivalent mg narcotic usage during hospital stay.	daily during hospital stay (an expected average of 4 days)	Yes
Secondary	Length of Stay		day of hospital discharge	Yes
Secondary	Harris Hip Score (Outcome Score)	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.	within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery	Yes
Secondary	Pain Score Scale	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.	within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery	Yes