Hip ArthritisPhase 4HipNCT01027195
Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty
A Phase 4 study testing Bipolar Radiofrequency (Aquamantys 6.0) and Standard Bovie Electrocautery in people with Hip Arthritis, run by The Cleveland Clinic.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Arthritis
- What is being tested?
- Bipolar Radiofrequency (Aquamantys 6.0) and Standard Bovie Electrocautery
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
About this study
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.
- Conditions
- Hip Arthritis
- Being tested
- Bipolar Radiofrequency (Aquamantys 6.0), Standard Bovie Electrocautery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar Radiofrequency (Aquamantys 6.0)Device
Also called Aquamantys 6.0
Standard Bovie ElectrocauteryDevice
| Study group | Role | What they receive |
|---|---|---|
| Standard Bovie Electrocautery | Placebo comparator | 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. Receives: Device: Standard Bovie Electrocautery |
| Bipolar Radiofrequency | Experimental | 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. Receives: Device: Bipolar Radiofrequency (Aquamantys 6.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Managed With Blood Transfusion
Measured: daily during hospital stay (an expected average of 4 days)
Secondary outcomes (7)
Number of Units Transfused
Measured: daily during hospital stay (an expected average of 4 days)
Estimated Blood Loss
Measured: Intraoperative (day of surgery)
Change in Hemoglobin Level
Change in hemoglobin level from baseline to the day of hospital discharge.
Measured: within 30 days before surgery (preop), day of hospital discharge
Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay
Sum of daily morphine-equivalent mg narcotic usage during hospital stay.
Measured: daily during hospital stay (an expected average of 4 days)
Length of Stay
Measured: day of hospital discharge
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.
Measured: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery
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.
Measured: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startAug 2006
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip ArthritisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Salient Surgical Technologies
- Responsible party
- Sponsor
- Investigators
- Wael K Barsoum, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027195
- Sponsor's protocol ID
- 06-615
- Acronym
- Hip
- Status last verified
- Oct 2012
- First submitted
- 3 Dec 2009
- Last updated
- 29 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21411700
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01027195
- Acronym / sponsor ID
- Hip / 06-615
- Conditions
- Hip Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Salient Surgical Technologies
- Study start
- Aug 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Dec 2009 (estimated)
- Results
- Posted 29 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Bovie Electrocautery | Placebo comparator | Device: Standard Bovie ElectrocauteryStandard 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. |
| Bipolar Radiofrequency | Experimental | Device: Bipolar Radiofrequency (Aquamantys 6.0)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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bipolar Radiofrequency (Aquamantys 6.0)Also: Aquamantys 6.0 | Device | Bipolar Radiofrequency |
| Standard Bovie Electrocautery | Device | Standard Bovie Electrocautery |
Primary outcome
Number of Patients Managed With Blood Transfusion
Time frame: daily during hospital stay (an expected average of 4 days)
7 secondary outcomes
Number of Units Transfused
Time frame: daily during hospital stay (an expected average of 4 days)
Estimated Blood Loss
Time frame: Intraoperative (day of surgery)
Change in Hemoglobin Level
Time frame: within 30 days before surgery (preop), 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)
Length of Stay
Time frame: day of hospital discharge
Harris Hip Score (Outcome Score)
Time frame: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery
Pain Score Scale
Time frame: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21411700Barsoum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael K Barsoum, MD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bipolar Radiofrequency (Aquamantys 6.0) and Standard Bovie Electrocautery in people with Hip Arthritis, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Managed With Blood Transfusion (time frame: daily during hospital stay (an expected average of 4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01027195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.