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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Mount Carmel Health System | OTHER |
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The purpose of this study is to establish whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.
To establish in a randomized, blinded study whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing based on early collected data. Data will be analyzed using StatsDirect in standard fashion to elucidate any difference between control and treatment groups. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquamantys Malleable Bipolar Sealer | Experimental | In 100 patients randomly assigned, primary total hip arthroplasty via an anterior supine intermuscular approach will be performed with the assistance of the Aquamantys Malleable Bipolar Sealer with Light. |
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| Standard Treatment | Active Comparator | 100 patients randomly assigned will undergo primary total hip arthroplasty via the anterior supine intermuscular approach performed with the assistance of standard electrocautery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquamantys | Device | Primary THA via the ASI approach will be performed using the Aquamantys Malleable Bipolar Sealer. The Aquamantys is a bipolar device that combines radio-frequency energy and saline to gently reach targeted tissue and provide a biomechanical seal. The saline acts as a conduit to allow the energy to penetrate the tissue from 1 to 2 mm where the collagen is transformed thus providing the seal. The saline also helps cool the tissue which allows for gentle handling of tissue, eliminating the black char that is a port for infection. The surgeon uses the Aquamantys to assist in tissue dissection, cauterize vessels, and to pre-treat fat pad in front of capsule prior to excision, to treat the entire anterior hip capsule prior to excision, treat oozing bone surfaces not covered by an implant. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Change in Hemoglobin Level | All patients will undergo routine lab work perioperatively. No additional studies will be necessary for this protocol. Hemoglobin level will be first measured preoperatively at the time of preadmission testing, which must be performed not more than 30 days prior to surgery, and then measured on postoperative day one. The two levels will be compared to assess the decrease in hemoglobin level resulting from the surgical intervention. | From up to 30 days preoperative through postoperative day 1 |
| Perioperative Blood Transfusion Requirement | Perioperative blood transfusion requirements will be recorded, including transfusions administered during the surgical intervention and throughout the acute hospital stay. | From the beginning of surgical intervention to hospital discharge, which averages 2 days and may be up to 1 week postoperative |
| Perioperative Blood Loss | Anesthesia and nursing records will be monitored for blood loss intraoperatively, and postoperatively via drain output. Drains will be pulled daily at 0600 and measured. | From beginning of surgical intervention through hospital discharge, which averages 2 days and may be up to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| The development of complications in the wound, either as an inpatient or after discharge | Wound care will be evaluated by a designee who will be blinded to the randomization. Wound will be evaluated for drainage, erythema, and ecchymosis. Additionally, the wound healing will be scored as: Healing better than expected, As expected, or Worse than expected. Wound evaluations will occur each postoperative day in hospital (average 2 days), at 6 weeks, and 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith R Berend, MD | Joint Implant Surgeons, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Implant Surgeons, Inc. | New Albany | Ohio | 43054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21411700 | Result | 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. | |
| 20097039 | Result | Zeh A, Messer J, Davis J, Vasarhelyi A, Wohlrab D. The Aquamantys system--an alternative to reduce blood loss in primary total hip arthroplasty? J Arthroplasty. 2010 Oct;25(7):1072-7. doi: 10.1016/j.arth.2009.10.008. Epub 2010 Jan 22. |
| Label | URL |
|---|---|
| Manufacturer's website; Related Info | View source |
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| standard electrocautery (Bovie) | Device | Primary total hip arthroplasty via an anterior supine intermuscular approach will be performed with the assistance of standard electrocautery. The electrocautery is used in tissue dissection and to cauterize bleeding vessels. |
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| Wound evaluations will occur each postoperative day in hospital (average 2 days and up to 1 week), at 6 weeks, and 1 year. |
| Length of stay | Length of acute hospital stay will be recorded. | From admission through hospital discharge (average 2 days, up to 1 week) |
| 21964452 | Result | Mankin KP, Moore CA, Miller LE, Block JE. Hemostasis with a bipolar sealer during surgical correction of adolescent idiopathic scoliosis. J Spinal Disord Tech. 2012 Jul;25(5):259-63. doi: 10.1097/BSD.0b013e3182334ec5. |
| 21082586 | Result | Morris MJ, Berend KR, Lombardi AV Jr. Hemostasis in anterior supine intermuscular total hip arthroplasty: pilot study comparing standard electrocautery and a bipolar sealer. Surg Technol Int. 2010 Oct;20:352-6. |
| 18331175 | Result | Marulanda GA, Ulrich SD, Seyler TM, Delanois RE, Mont MA. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices. 2008 Mar;5(2):125-31. doi: 10.1586/17434440.5.2.125. |
| 16525984 | Result | Marulanda GA, Ragland PS, Seyler TM, Mont MA. Reductions in blood loss with use of a bipolar sealer for hemostasis in primary total knee arthroplasty. Surg Technol Int. 2005;14:281-6. |
| 20145794 | Result | Marulanda GA, Krebs VE, Bierbaum BE, Goldberg VM, Ries M, Ulrich SD, Seyler TM, Mont MA. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2009 Dec;38(12):E179-83. |
| Related info; animated sequence | View source |
| Related info | View source |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D016916 | Joint Deformities, Acquired |
| D006618 | Hip Dislocation, Congenital |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| D016063 | Blood Loss, Surgical |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| D004564 | Electrocoagulation |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
| D002425 | Cautery |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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