Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The overall objectives and purpose of this study is to show that the Smith and Nephew Werewolf Fastseal 6.0 Bipolar Sealer is an effective tool to aide the surgical team in providing significant hemostasis during anterior total hip arthroplasty which would subsequently improve patient outcomes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group Receiving Fastseal | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Werewolf Fastseal 6.0 | Device | bi-polar hemostatic wand |
|
| Measure | Description | Time Frame |
|---|---|---|
| post-operative hemoglobin | obtained from point of care testing (hemocue hgb 801 device) in clinic (g/dL) | taken at 48-72 hours post op |
| intra-operative total blood loss | total blood loss approximated in milliliters from measuring output in suction canister and input from fluid bags with measurement markings | taken at time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative need for transfusion | measured in units given | 6 weeks post operative period |
| Mean operative time ("skin to skin") | measured in hh:mm:ss |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mohammad U Burney, MD | NTMRI, OSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Health Sugery Center - Rockwall | Rockwall | Texas | 75032 | United States | ||
| Baylor Scott & White - Lake Pointe Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26521781 | Background | Gao FQ, Li ZJ, Zhang K, Sun W, Zhang H. Four Methods for Calculating Blood-loss after Total Knee Arthroplasty. Chin Med J (Engl). 2015 Nov 5;128(21):2856-60. doi: 10.4103/0366-6999.168041. | |
| 26880328 | Background | Nichols CI, Vose JG. Clinical Outcomes and Costs Within 90 Days of Primary or Revision Total Joint Arthroplasty. J Arthroplasty. 2016 Jul;31(7):1400-1406.e3. doi: 10.1016/j.arth.2016.01.022. Epub 2016 Jan 21. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| intra-operative |
| incidence of VTE | absolute value, diagnosed via VDS within 6 weeks | for post-operative 6 weeks |
| patient reported pain scoring | numerical score, patient reported. ranges from 0 = no pain to 10 = worst pain | measured at preop, 2 weeks, 6 weeks |
| patient reported pain prescription drug usage | patient reported as far as pain rx used and how many pills/hr (e.g. "I use norco 5-325. I pill every 8 hours currently"). | measured at post-operative period of 6 weeks |
| Harris Hip Score analysis 6 weeks post operative visits | established orthopaedic score used to measure functionality of the hip, reported as numerical value. this will be aggregated and reported as a mean at study completion | measured at preop, and at 6 weeks |
| length of hospital stay | This will be measured with chart review and reported as "0" for <24 hour discharge and each subsequent 24 hour period as "1, 2, 3, etc". | post-operative for 6 weeks |
| Rowlett |
| Texas |
| 75088 |
| United States |
| 18331175 | Background | 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. |
| Background | Procyk S. The Transcollation: Short Hospitals Stay and Accelerated Recovery in Total Hip and Knee Arthroplasties Using a Radiofrequency Bipolar Sealer - an Innovative Approach in the Conceptualization of the Surgical Gesture. Natl Acad of Surg 2015:15(2):87-97. |
| 17570284 | Background | Rosenberg AG. Reducing blood loss in total joint surgery with a saline-coupled bipolar sealing technology. J Arthroplasty. 2007 Jun;22(4 Suppl 1):82-5. doi: 10.1016/j.arth.2007.02.018. |
| 24810825 | Result | Ackerman SJ, Tapia CI, Baik R, Pivec R, Mont MA. Use of a bipolar sealer in total hip arthroplasty: medical resource use and costs using a hospital administrative database. Orthopedics. 2014 May;37(5):e472-81. doi: 10.3928/01477447-20140430-59. |
| 9973048 | Result | Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002. |
| D012216 |
| Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |