Phase 4
N=140
Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty
Hip Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01027195 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Number of Patients Managed With Blood Transfusion — 15; 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bipolar Radiofrequency (Aquamantys 6.0) (Device); Standard Bovie Electrocautery (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Managed With Blood Transfusion |
15; 14 | — |
| SECONDARY Number of Units Transfused |
0.38; 0.44 | — |
| SECONDARY Estimated Blood Loss |
315.2; 368.5 | — |
| SECONDARY Change in Hemoglobin Level |
-5.4; -5.3 | — |
| SECONDARY Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay |
156.1; 164.9 | — |
| SECONDARY Length of Stay |
3.3; 3.4 | — |
| SECONDARY Harris Hip Score (Outcome Score) |
59.0; 60.4; 78.4; 78.4; 92.8; 95.1 | — |
| SECONDARY Pain Score Scale |
6.2; 6.4; 1.7; 1.7; 1.2; 0.9 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01027195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.