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Fish Oil in Total Hip Replacement Randomized Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360239
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey L Stimac MD, Norton Healthcare

Brief Summary:
The purpose of this study is to determine if continuing fish oil supplementation leads to higher blood loss in patients undergoing total hip arthroplasty (THA). Another purpose is to determine if patients on fish oil have less pain after THA. Fish oil (Omega-3 fatty acid) is commonly used by patients as a natural anti-inflammatory to decrease joint pain from arthritis. Supplements, including fish oil, are typically stopped 1-2 weeks prior to surgery as there is an increased risk of perioperative bleeding. However, there are current methods in joint replacement surgery that decrease the risk of perioperative bleeding. With the risk of excessive bleeding being minimized, fish oil may not need to be stopped prior to surgery and could be continued immediately after surgery. The anti-inflammatory effect of fish oil may also help decrease pain after surgery.

Condition or disease Intervention/treatment Phase
Total Hip Arthroplasty Dietary Supplement: Fish Oil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Stopping Fish Oil Supplementation Prior to Total Hip Replacement a Randomized Clinical Trial
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: Fish Oil
Fish-Oil naïve subjects will be started on fish oil 4 weeks prior to surgery and continued until the 6 week follow up. Subjects already taking fish oil will be switched to the study fish-oil formulation of two capsules twice daily (3000 mg of EPA and DHA).
Dietary Supplement: Fish Oil
Fish-oil formulation of two capsules twice daily (3000 mg of EPA and DHA).

No Intervention: Control
No fish oil supplementation



Primary Outcome Measures :
  1. Total perioperative blood loss [ Time Frame: Post-operative day 5 ]
    Calculated total perioperative blood loss (mL) using Bourke's, Gross', Camarasa's, and Lopez-Picado's formula based on Post Operative Day 5 (POD5) Hemoglobin and Hematocrit


Secondary Outcome Measures :
  1. Post-operative day 1 Hemoglobin [ Time Frame: Post-operative day 1 ]
    Post-operative day 1 Hemoglobin

  2. Post-operative day 1 Hematocrit [ Time Frame: Post-operative day 1 ]
    Post-operative day 1 Hematocrit


Other Outcome Measures:
  1. Post-operative pain scores [ Time Frame: Post-operative day 1 pain scores will be determined for each patient using the visual analog scale ]
    Post-operative pain scores will be determined for each patient using a numeric rating scales (NRS) with 0 being no pain and 10 being worst pain possible.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients ≥ 18 years old
  • Primary total hip arthroplasty
  • Diagnosis of osteoarthritis
  • Able to consume fish oil
  • Medically cleared for surgery
  • Plan for unilateral total hip arthroplasty
  • Able to consent to surgery and study participation

Exclusion Criteria:

  • Unable to consent for study participation
  • Unable to participate in preoperative testing
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • Patient reports of easy bruising
  • Revision total hip replacement
  • Indication for surgery other than osteoarthritis
  • History of surgical wound complication on involved extremity
  • Allergy to fish oil
  • Allergy to Aspirin
  • Patients on Coumadin, Eliquis, Xarelto or other anticoagulants (excluding NSAIDs)
  • Outpatient total hip replacement
  • Bilateral total hip replacement
  • Coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360239


Contacts
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Contact: Jeffrey D Stimac, MD 502-394-6341 Jeffrey.Stimac2@nortonhealthcare.org
Contact: Leah Carreon, MD 502.992.0488 ext 14139 Leah.Carreon@nortonhealthcare.org

Sponsors and Collaborators
Jeffrey L Stimac MD
Investigators
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Principal Investigator: Jeffrey D Stimac, MD Norton Healthcare
Publications:
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Responsible Party: Jeffrey L Stimac MD, Principal Investigator, Norton Healthcare
ClinicalTrials.gov Identifier: NCT04360239    
Other Study ID Numbers: 19-N0364
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffrey L Stimac MD, Norton Healthcare:
Fish Oil
Total Hip Arthroplasty
Blood management
Blood Loss