Efficacy of Aquamantys for Reducing Transfusions With Anterior Supine Intermuscular Approach Total Hip Arthroplasty
This study has been completed.
Sponsor:
Joint Implant Surgeons, Inc.
Collaborators:
Medtronic
Mount Carmel Health System
Information provided by (Responsible Party):
Keith R. Berend, Joint Implant Surgeons, Inc.
ClinicalTrials.gov Identifier:
NCT01583465
First received: April 18, 2012
Last updated: April 23, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoarthritis, Hip Joint Deformities, Acquired Hip Dislocation, Congenital Osteonecrosis Arthritis, Rheumatoid |
Device: Aquamantys Device: standard electrocautery (Bovie) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Open Label, Randomized, Blinded Study to Evaluate the Efficacy of Aquamantys System for Reducing the Transfusion Requirements Associated With the Anterior-Supine Intermuscular (ASI) Approach for Total Hip Arthroplasty (THA) |
Resource links provided by NLM:
MedlinePlus related topics:
Blood Transfusion and Donation
Dislocations
Hip Injuries and Disorders
Osteoarthritis
Osteonecrosis
Rheumatoid Arthritis
Shoulder Injuries and Disorders
U.S. FDA Resources
Further study details as provided by Joint Implant Surgeons, Inc.:
Primary Outcome Measures:
- Perioperative Change in Hemoglobin Level [ Time Frame: From up to 30 days preoperative through postoperative day 1 ] [ Designated as safety issue: Yes ]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.
- Perioperative Blood Transfusion Requirement [ Time Frame: From the beginning of surgical intervention to hospital discharge, which averages 2 days and may be up to 1 week postoperative ] [ Designated as safety issue: Yes ]Perioperative blood transfusion requirements will be recorded, including transfusions administered during the surgical intervention and throughout the acute hospital stay.
- Perioperative Blood Loss [ Time Frame: From beginning of surgical intervention through hospital discharge, which averages 2 days and may be up to 1 week ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- The development of complications in the wound, either as an inpatient or after discharge [ Time Frame: Wound evaluations will occur each postoperative day in hospital (average 2 days and up to 1 week), at 6 weeks, and 1 year. ] [ Designated as safety issue: Yes ]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.
- Length of stay [ Time Frame: From admission through hospital discharge (average 2 days, up to 1 week) ] [ Designated as safety issue: Yes ]Length of acute hospital stay will be recorded.
| Enrollment: | 200 |
| Study Start Date: | October 2009 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aquamantys Malleable Bipolar Sealer
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.
|
Device: Aquamantys
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.
Other Names:
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Active Comparator: Standard Treatment
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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Device: standard electrocautery (Bovie)
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.
Other Names:
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Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Undergoing primary unilateral total hip arthroplasty via the anterior supine intermuscular approach
- Patient is willing and able to complete all follow-up visits at 6 weeks and 1 year
Exclusion Criteria:
- Patients with pre-existing known coagulopathy
- Patients on chronic Coumadin (Warfarin) therapy
- Patients receiving erythropoietin therapy for anemia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583465
Locations
| United States, Ohio | |
| Joint Implant Surgeons, Inc. | |
| New Albany, Ohio, United States, 43054 | |
Sponsors and Collaborators
Joint Implant Surgeons, Inc.
Medtronic
Mount Carmel Health System
Investigators
| Principal Investigator: | Keith R Berend, MD | Joint Implant Surgeons, Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | Keith R. Berend, Principal Investigator, Joint Implant Surgeons, Inc. |
| ClinicalTrials.gov Identifier: | NCT01583465 History of Changes |
| Other Study ID Numbers: | 20091312 |
| Study First Received: | April 18, 2012 |
| Last Updated: | April 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Joint Implant Surgeons, Inc.:
|
randomized controlled trial Blood loss, surgical Blood loss, postoperative Wound healing |
Additional relevant MeSH terms:
|
Congenital Abnormalities Arthritis Arthritis, Rheumatoid Dislocations Hip Dislocation Hip Dislocation, Congenital Osteoarthritis Osteoarthritis, Hip Osteonecrosis Joint Deformities, Acquired Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Wounds and Injuries Hip Injuries Musculoskeletal Abnormalities Bone Diseases Necrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013