Hip Arthritis
Conditions
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.
Interventions
DEVICEBipolar Radiofrequency (Aquamantys 6.0)
DEVICEStandard Bovie Electrocautery
Sponsors
Salient Surgical Technologies
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Managed With Blood Transfusion | daily during hospital stay (an expected average of 4 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss | Intraoperative (day of surgery) | — |
| Change in Hemoglobin Level | within 30 days before surgery (preop), day of hospital discharge | Change in hemoglobin level from baseline to the day of hospital discharge. |
| Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay | daily during hospital stay (an expected average of 4 days) | Sum of daily morphine-equivalent mg narcotic usage during hospital stay. |
| Number of Units Transfused | daily during hospital stay (an expected average of 4 days) | — |
| Harris Hip Score (Outcome Score) | 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. |
| Pain Score Scale | 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. |
| Length of Stay | day of hospital discharge | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 71 |
| 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. | 69 |
| Total | 140 |
Baseline characteristics
| Characteristic | Bipolar Radiofrequency | Standard Bovie Electrocautery | Total |
|---|---|---|---|
| Age Continuous | 55.4 years STANDARD_DEVIATION 10.9 | 55.7 years STANDARD_DEVIATION 11 | 55.5 years STANDARD_DEVIATION 11 |
| Baseline Hemoglobin | 14.6 g/dL STANDARD_DEVIATION 1.3 | 14.2 g/dL STANDARD_DEVIATION 1.2 | 14.4 g/dL STANDARD_DEVIATION 1.3 |
| Body-Mass Index Females | 28.6 kg/m2 STANDARD_DEVIATION 7.1 | 29.2 kg/m2 STANDARD_DEVIATION 6.1 | 28.9 kg/m2 STANDARD_DEVIATION 6.6 |
| Body-Mass Index Males | 29.4 kg/m2 STANDARD_DEVIATION 4.7 | 30.4 kg/m2 STANDARD_DEVIATION 5.1 | 29.9 kg/m2 STANDARD_DEVIATION 4.9 |
| Sex: Female, Male Female | 35 Participants | 31 Participants | 66 Participants |
| Sex: Female, Male Male | 36 Participants | 38 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 71 | 4 / 69 |
| serious Total, serious adverse events | 0 / 71 | 0 / 69 |
Outcome results
Primary
Number of Patients Managed With Blood Transfusion
Time frame: daily during hospital stay (an expected average of 4 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bipolar Radiofrequency | Number of Patients Managed With Blood Transfusion | 15 participants |
| Standard Bovie Electrocautery | Number of Patients Managed With Blood Transfusion | 14 participants |
Secondary
Change in Hemoglobin Level
Change in hemoglobin level from baseline to the day of hospital discharge.
Time frame: within 30 days before surgery (preop), day of hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bipolar Radiofrequency | Change in Hemoglobin Level | -5.4 g/dL | Standard Deviation 1.6 |
| Standard Bovie Electrocautery | Change in Hemoglobin Level | -5.3 g/dL | Standard Deviation 1.8 |
Secondary
Estimated Blood Loss
Time frame: Intraoperative (day of surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bipolar Radiofrequency | Estimated Blood Loss | 315.2 mL | Standard Deviation 203.4 |
| Standard Bovie Electrocautery | Estimated Blood Loss | 368.5 mL | Standard Deviation 277.8 |
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.
Time frame: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bipolar Radiofrequency | Harris Hip Score (Outcome Score) | Preoperative | 59.0 points on a scale | Standard Deviation 12.2 |
| Bipolar Radiofrequency | Harris Hip Score (Outcome Score) | 4 Weeks Postoperative | 78.4 points on a scale | Standard Deviation 9.8 |
| Bipolar Radiofrequency | Harris Hip Score (Outcome Score) | 12 Weeks Postoperative | 92.8 points on a scale | Standard Deviation 8.2 |
| Standard Bovie Electrocautery | Harris Hip Score (Outcome Score) | 4 Weeks Postoperative | 78.4 points on a scale | Standard Deviation 11.2 |
| Standard Bovie Electrocautery | Harris Hip Score (Outcome Score) | Preoperative | 60.4 points on a scale | Standard Deviation 11.6 |
| Standard Bovie Electrocautery | Harris Hip Score (Outcome Score) | 12 Weeks Postoperative | 95.1 points on a scale | Standard Deviation 5.4 |
Secondary
Length of Stay
Time frame: day of hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bipolar Radiofrequency | Length of Stay | 3.3 days | Standard Deviation 1.1 |
| Standard Bovie Electrocautery | Length of Stay | 3.4 days | Standard Deviation 1.6 |
Secondary
Number of Units Transfused
Time frame: daily during hospital stay (an expected average of 4 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bipolar Radiofrequency | Number of Units Transfused | 0.38 units of blood | Standard Deviation 0.83 |
| Standard Bovie Electrocautery | Number of Units Transfused | 0.44 units of blood | Standard Deviation 0.98 |
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.
Time frame: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bipolar Radiofrequency | Pain Score Scale | Preoperative | 6.2 points on a scale | Standard Deviation 2.2 |
| Bipolar Radiofrequency | Pain Score Scale | 4 Weeks Postoperative | 1.7 points on a scale | Standard Deviation 1.7 |
| Bipolar Radiofrequency | Pain Score Scale | 12 Weeks Postoperative | 1.2 points on a scale | Standard Deviation 1.7 |
| Standard Bovie Electrocautery | Pain Score Scale | Preoperative | 6.4 points on a scale | Standard Deviation 2 |
| Standard Bovie Electrocautery | Pain Score Scale | 4 Weeks Postoperative | 1.7 points on a scale | Standard Deviation 1.8 |
| Standard Bovie Electrocautery | Pain Score Scale | 12 Weeks Postoperative | 0.9 points on a scale | Standard Deviation 1.2 |
Secondary
Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay
Sum of daily morphine-equivalent mg narcotic usage during hospital stay.
Time frame: daily during hospital stay (an expected average of 4 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bipolar Radiofrequency | Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay | 156.1 total morphine-equivalent mg | Standard Deviation 130.2 |
| Standard Bovie Electrocautery | Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay | 164.9 total morphine-equivalent mg | Standard Deviation 123.4 |