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

Status: Unknown
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Texas Health Sugery Center - Rockwall
Rockwall
Baylor Scott & White - Lake Pointe Medical Center
Rowlett
Time Frame
Start Date: 2022-04-29
Completion Date: 2024-02-01
Participants
Target number of participants: 75
Treatments
Other: Intervention Group Receiving Fastseal
Sponsors
Collaborators: Smith & Nephew, Inc.
Leads: North Texas Medical Research Institute, PLLC

This content was sourced from clinicaltrials.gov