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This study will compare the clinical outcomes for patients undergoing a total knee replacement using a bipolar sealer, the Aquamantys® System, as compared to standard electrocautery. Total blood loss during the hospital stay and knee mobility and discharge factors will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrocautery | Placebo Comparator | Use of electrocautery in tourniquet and without tourniquet total knee replacement surgery. |
|
| Bipolar Sealer Aquamantys | Active Comparator | Use of bipolar sealer Aquamantys in tourniquet and tourniquetless total knee replacement surgical procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocautery | Device | Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss | The primary outcome will be total blood loss throughout the hospital stay. | upto to 72 hrs after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rehabilitation | Discharge criteria evaluated. | 6-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard E Field, Md, PhD, FRCS | SWLEOC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South West London Elective Orthopaedic Center | Epsom | Surrey | Kt18 7EG | United Kingdom | ||
| Freeman Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20145794 | Background | 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. | |
| 16525984 | Background | 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. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007239 | Infections |
| D007249 | Inflammation |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| ID | Term |
|---|---|
| D002425 | Cautery |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Bipolar sealer Aquamantys | Device | Aquamantys use in tourniquet and tourniquetless total knee replacement. |
|
|
| Newcastle upon Tyne |
| United Kingdom |
| 19675727 | Background | Pfeiffer M, Brautigam H, Draws D, Sigg A. A new bipolar blood sealing system embedded in perioperative strategies vs. a conventional regimen for total knee arthroplasty: results of a matched-pair study. Ger Med Sci. 2005 Dec 13;3:Doc10. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |