Fish Oil in Total Hip Replacement Randomized Clinical Trial
Stopping Fish Oil Supplementation Prior to Total Hip Replacement a Randomized Clinical Trial
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2022
CompletedOctober 26, 2024
June 1, 2022
1.8 years
March 5, 2020
October 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total perioperative blood loss
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
Post-operative day 5
Secondary Outcomes (2)
Post-operative day 1 Hemoglobin
Post-operative day 1
Post-operative day 1 Hematocrit
Post-operative day 1
Other Outcomes (1)
Post-operative pain scores
Post-operative day 1 pain scores will be determined for each patient using the visual analog scale
Study Arms (2)
Fish Oil
EXPERIMENTALFish-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).
Control
NO INTERVENTIONNo fish oil supplementation
Interventions
Fish-oil formulation of two capsules twice daily (3000 mg of EPA and DHA).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Norton Healthcare
Louisville, Kentucky, 40241, United States
Related Publications (6)
Akintoye E, Sethi P, Harris WS, Thompson PA, Marchioli R, Tavazzi L, Latini R, Pretorius M, Brown NJ, Libby P, Mozaffarian D. Fish Oil and Perioperative Bleeding. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004584. doi: 10.1161/CIRCOUTCOMES.118.004584.
PMID: 30571332BACKGROUNDBoe C, Vangsness CT. Fish Oil and Osteoarthritis: Current Evidence. Am J Orthop (Belle Mead NJ). 2015 Jul;44(7):302-5.
PMID: 26161757BACKGROUNDCalder PC. Omega-3 fatty acids and inflammatory processes: from molecules to man. Biochem Soc Trans. 2017 Oct 15;45(5):1105-1115. doi: 10.1042/BST20160474. Epub 2017 Sep 12.
PMID: 28900017BACKGROUNDConnor SL, Connor WE. Are fish oils beneficial in the prevention and treatment of coronary artery disease? Am J Clin Nutr. 1997 Oct;66(4 Suppl):1020S-1031S. doi: 10.1093/ajcn/66.4.1020S.
PMID: 9322583BACKGROUNDKremer JM. Fish Oil and Inflammation - A Fresh Look. J Rheumatol. 2017 Jun;44(6):713-716. doi: 10.3899/jrheum.161551. No abstract available.
PMID: 28572471BACKGROUNDTummala R, Ghosh RK, Jain V, Devanabanda AR, Bandyopadhyay D, Deedwania P, Aronow WS. Fish Oil and Cardiometabolic Diseases: Recent Updates and Controversies. Am J Med. 2019 Oct;132(10):1153-1159. doi: 10.1016/j.amjmed.2019.04.027. Epub 2019 May 8.
PMID: 31077653BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey D Stimac, MD
Norton Healthcare
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 5, 2020
First Posted
April 24, 2020
Study Start
June 1, 2020
Primary Completion
March 22, 2022
Study Completion
July 10, 2022
Last Updated
October 26, 2024
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share