Bipolar Sealer for Reduction of Blood Loss in Anterior Total Hip Arthroplasties

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Prospective Trial of Bipolar Sealer for Reduction of Intra-Operative Blood Loss in Total Hip Arthroplasty Utilizing the Anterior Hip Approach

Conditions
-----------------
Osteoarthritis, Hip, Blood Loss

Intervention / Treatment
-----------------
* Device: Werewolf Fastseal 6.0


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is to undergo a standard of care primary total hip replacement for degenerative joint disease. All devices are to be used according to the approved indications, this includes the FDA approved Werewolf Fastseal Bipolar Device. The patient is expected to have an outpatient status and will be discharged <23 hours. Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study. Individuals who are willing and able to complete follow-up visits and questionnaires as specified by the study protocol. Individuals who are not bedridden per the discretion of the investigator (The intent of not bedridden means a permanent situation, not a temporary situation as in a hip fracture or trauma case). Individuals who are a minimum age of 21 years and less than 80 years at the time of consent. Exclusion Criteria: Active local or systemic infection. Hematologic disease either inherited or acquired, that would predispose the patient to anemia or increased intra-operative blood loss Currently taking anti-coagulation medications more than 81 mg aspirin every day. Platelet disorder either inherited or acquired with a serum platelet level <150,000 platelets per microliter. Coagulopathy as seen with routine lab work Unstable/uncontrolled cardiovascular disease such as congestive heart failure, hypertension, or renal disease such as GFR <70, in the opinion of the investigative team and PI. Excessive alcohol intake or tobacco use, in the opinion of the investigator. Uncontrolled diabetes mellitus with hemoglobin a1c >7.5%. Established history of previous venous thrombotic events (VTE). Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified. The subject is a woman who is pregnant or lactating. Subject had a contralateral amputation. Previous partial hip replacement in affected hip. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months. Contralateral hip was replaced less than 3 months prior to surgery date, contralateral hip is already enrolled in the study, or simultaneous or staged hip replacement is planned Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a physical or psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention Group Receiving Fastseal<br> | Device: Werewolf Fastseal 6.0<br>* bi-polar hemostatic wand<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |