Status:
COMPLETED
Oxidative Stress and Surgical Recovery
Lead Sponsor:
Stanford University
Conditions:
Surgical Recovery
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Chronic pain, functional impairment and slow rates of recovery are key issues for patients after surgery and trauma. No preventative strategy in current use unequivocally modifies these rates, and few...
Detailed Description
This is a randomized, double-blind, placebo controlled interventional pilot study in 20 patients undergoing first-time total hip arthroplasty (THA) for chronic osteoarthritis at Stanford Medicine. The...
Eligibility Criteria
Inclusion
- Over 18
- Male of female
- Planning to undergo primary total hip arthroplasty
- Fluent in English
- Willing and able to sign an informed consent form and HIPAA authorization and to comply with study procedures
Exclusion
- Infectious disease within the last month
- Immune-suppressant therapy within the last 2 months (e.g., azathioprine or cyclosporine)
- Chronic medication with potential immune-modulatory effects (e.g., daily oral morphine-equivalent intake \> 30 mg)
- Major surgery within the last 3 months or minor surgery within the last month.
- History of substance abuse (e.g., alcoholism, drug dependency)
- Pregnancy
- Autoimmune disease interfering with data interpretation (e.g. lupus)
- Renal, hepatic, cardiovascular, or respiratory diseases resulting in clinically relevant impaired function
- Active malignancy
- Participation in another clinical trial of an investigational drug or device within the last month that, in the investigator's opinion, would create an increased risk to the participant or compromise the integrity of the study
- Other conditions compromising a participant's safety or the integrity of the study
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04732000
Start Date
July 1 2021
End Date
March 1 2023
Last Update
April 30 2025
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305