Osteoarthritis, HipNCT05356637
Bipolar Sealer for Reduction of Blood Loss in Anterior Total Hip Arthroplasties
A study testing Werewolf Fastseal 6.0 in people with Osteoarthritis, Hip and Blood Loss, run by North Texas Medical Research Institute, PLLC at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Blood Loss
- What is being tested?
- Werewolf Fastseal 6.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Apr 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Health Sugery Center - Rockwall
Rockwall, Texas, 75032
Baylor Scott & White - Lake Pointe Medical Center
Rowlett, Texas, 75088
About this study
Official title: Prospective Trial of Bipolar Sealer for Reduction of Intra-Operative Blood Loss in Total Hip Arthroplasty Utilizing the Anterior Hip Approach
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
- Being tested
- Werewolf Fastseal 6.0
- Medical subject headings
- Osteoarthritis, Hip, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Werewolf Fastseal 6.0Device
bi-polar hemostatic wand
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group Receiving Fastseal | Other | Not described Receives: Device: Werewolf Fastseal 6.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative hemoglobin
obtained from point of care testing (hemocue hgb 801 device) in clinic (g/dL)
Measured: 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
Measured: taken at time of surgery
Secondary outcomes (7)
Post-operative need for transfusion
measured in units given
Measured: 6 weeks post operative period
Mean operative time ("skin to skin")
measured in hh:mm:ss
Measured: intra-operative
incidence of VTE
absolute value, diagnosed via VDS within 6 weeks
Measured: for post-operative 6 weeks
patient reported pain scoring
numerical score, patient reported. ranges from 0 = no pain to 10 = worst pain
Measured: 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: 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: 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".
Measured: post-operative for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start29 Apr 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Texas Medical Research Institute, PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Principal investigator, Mohammad Umar Burney, MD, North Texas Medical Research Institute, PLLC
- Investigators
- Mohammad U Burney, MD, Principal investigator, NTMRI, OSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356637
- Sponsor's protocol ID
- SN-012022-01
- Status last verified
- Oct 2023
- First submitted
- 28 Mar 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 26521781Nichols 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.
PubMed 26880328Marulanda 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.
PubMed 18331175Procyk 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.
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.
PubMed 17570284Ackerman 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.
PubMed 24810825Bierbaum 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.
PubMed 9973048
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of Bipolar Sealer for Reduction of Intra-Operative Blood Loss in Total Hip Arthroplasty Utilizing the Anterior Hip Approach
- ClinicalTrials.gov ID
- NCT05356637
- Acronym / sponsor ID
- SN-012022-01
- Conditions
- Osteoarthritis, Hip, Blood Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- North Texas Medical Research Institute, PLLCUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group Receiving Fastseal | Other | Device: Werewolf Fastseal 6.0 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Werewolf Fastseal 6.0bi-polar hemostatic wand | Device | Intervention Group Receiving Fastseal |
Primary outcome
post-operative hemoglobin
Time frame: taken at 48-72 hours post op
obtained from point of care testing (hemocue hgb 801 device) in clinic (g/dL)
intra-operative total blood loss
Time frame: taken at time of surgery
total blood loss approximated in milliliters from measuring output in suction canister and input from fluid bags with measurement markings
7 secondary outcomes
Post-operative need for transfusion
Time frame: 6 weeks post operative period
Mean operative time ("skin to skin")
Time frame: intra-operative
incidence of VTE
Time frame: for post-operative 6 weeks
patient reported pain scoring
Time frame: measured at preop, 2 weeks, 6 weeks
patient reported pain prescription drug usage
Time frame: measured at post-operative period of 6 weeks
Harris Hip Score analysis 6 weeks post operative visits
Time frame: measured at preop, and at 6 weeks
length of hospital stay
Time frame: post-operative for 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 26521781Gao 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.
- Background: PubMed 26880328Nichols 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.
- Background: PubMed 18331175Marulanda 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.
- BackgroundProcyk 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: PubMed 17570284Rosenberg 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.
- Results publication: PubMed 24810825Ackerman 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.
- Results publication: PubMed 9973048Bierbaum 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad U Burney, MD principal investigator
NTMRI, OSD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Werewolf Fastseal 6.0 in people with Osteoarthritis, Hip and Blood Loss, run by North Texas Medical Research Institute, PLLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative hemoglobin (time frame: taken at 48-72 hours post op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05356637, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.