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

Status unconfirmed · Not applicable

Conditions studied: Osteoarthritis, Hip, Blood Loss

In brief

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.

Key facts

Study ID

NCT05356637

Run by

North Texas Medical Research Institute, PLLC

People needed

75

Starts

2022-04-29

Expected to finish

2024-02-01

Last updated by the study team

2023-10-31

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Texas Health Sugery Center - Rockwall — Rockwall, Texas, United States
• Baylor Scott & White - Lake Pointe Medical Center — Rowlett, Texas, United States

Full record on ClinicalTrials.gov

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