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

NCT05356637 | Unknown FDA Device

• 1 other identifier: SN-012022-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis, Hip; Blood Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Post-operative need for transfusion

  6 weeks post operative period

• Mean operative time ("skin to skin")

  intra-operative

• incidence of VTE

  for post-operative 6 weeks

• patient reported pain scoring

  measured at preop, 2 weeks, 6 weeks

• patient reported pain prescription drug usage

  measured at post-operative period of 6 weeks

Study Arms (1)

Intervention Group Receiving Fastseal

OTHER

Device: Werewolf Fastseal 6.0

Interventions

Werewolf Fastseal 6.0 DEVICE

bi-polar hemostatic wand

Intervention Group Receiving Fastseal

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• North Texas Medical Research Institute, PLLC: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (2)

Texas Health Sugery Center - Rockwall

Rockwall, Texas, 75032, United States

Location

Baylor Scott & White - Lake Pointe Medical Center

Rowlett, Texas, 75088, United States

Location

Related Publications (7)

• 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.

  PMID: 26521781 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.

  PMID: 26880328 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.

  PMID: 18331175 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.

  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.

  PMID: 17570284 BACKGROUND

• 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.

  PMID: 24810825 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.

  PMID: 9973048 RESULT

MeSH Terms

Conditions

Osteoarthritis, Hip; Hemorrhage

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad U Burney, MD

  NTMRI, OSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Medical Director

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: May 2, 2022
• Study Start: April 29, 2022
• Primary Completion: January 31, 2024
• Study Completion: February 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

US (2)