RECRUITING

Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective randomized controlled trial that will assess preoperative, perioperative, and long-term oxidative stress (OS); pain; and functional outcomes over a 12 month period and test the hypothesis that a potent antioxidant intervention (glycine + N-acetyl-cysteine(GlyNAC)) reduces oxidative stress and chronic post surgical pain (CPSP) in patients undergoing total knee arthroplasty (TKA).

Official Title

Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty

Quick Facts

Study Start:2024-12
Study Completion:2029-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06083480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 50 or older
  2. * Intact cognitive status and ability to provide informed consent (based on cognitive screening with the Mini Mental State Examination)
  3. * Ability to read and write in English sufficiently to understand and complete study questionnaires
  4. * Undergoing unilateral primary TKA
  5. * Medical diagnosis of osteoarthritis
  6. * Past 24 hour worst numeric rating scale (NRS) pain of at least 4/10.
  1. * Diagnosis of pre-existing neuropathy
  2. * Untreated hypo/hyperthyroidism
  3. * Untreated heart disease
  4. * Alanine transaminase/aspartate transaminase \>2x upper-limit of normal range
  5. * serum creatinine \>1.5 mg/dl
  6. * Pregnancy
  7. * Complex Regional Pain Syndrome (CRPS) diagnosis prior to undergoing TKA
  8. * Presence of lower extremity vascular disease, inflammatory or autoimmune disorders, or malignancy
  9. * Presence of current clinically significant chronic pain conditions outside of the lower extremity ( daily pain for \>3 months and greater ≥3/10 in intensity or the focus of medical care)
  10. * Presence of other medical conditions that in the opinion of the orthopedic surgeon co-investigators would make a patient's study participation unsafe

Contacts and Locations

Study Contact

Stephen Bruehl, Ph.D.
CONTACT
(615) 936-1821
stephen.bruehl@vumc.org
Gail Mayo, RN
CONTACT
615-936-1705
gail.mayo@vumc.org

Principal Investigator

Stephen Bruehl, Ph.D.
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Frederic T Billings, IV, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Stephen Bruehl, Ph.D., PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center
  • Frederic T Billings, IV, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12
Study Completion Date2029-03

Study Record Updates

Study Start Date2024-12
Study Completion Date2029-03

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoarthritis, Knee
  • Total Knee Arthroplasty
  • Chronic Postsurgical Pain