Status:
COMPLETED
Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in TJA
Lead Sponsor:
University of Arkansas
Conditions:
Osteoarthritis, Knee
Osteoarthritis, Hip
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
In this pilot study, we will test the hypothesis that a POPOP for currently ineligible UAMS orthopedic surgery patients wanting hip or knee replacement improves markers of preoperative health, ability...
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will be screened to determine eligibility for study entry. Patients who meet eligibility criteria...
Eligibility Criteria
Inclusion
- End-stage knee or hip osteoarthritis, avascular necrosis, or rheumatoid arthritis with recommended primary, unilateral total joint arthroplasty by orthopaedic surgeons at the University of Arkansas for Medical Sciences (Jeffrey Stambough, Dr. C. Lowry Barnes, Dr. Simon Mears, and Dr. Benjamin Stronach)
- BMI between 41.00-48.00 kg/m2 at time of enrollment
- Over the age of 18 years
- Would consider undergoing a total joint arthroplasty if eligible
- Owns a smartphone or tablet with Bluetooth capability, cell signal or WIFI connection
- Willing to comply with the requirements of the study and provide informed consent prior to enrollment.
Exclusion
- Patients with a BMI less than 41.00 or greater than 48.00
- Pregnancy
- Breastfeeding
- History of a major organ transplant or other health issue requiring immunosuppressant drugs
- Strict vegetarian diet
- Diagnosis of and/or are taking medication for psychiatric conditions including schizophrenia, bipolar disorder or manic depression
- Patients scheduled for, or those who have previously undergone, bariatric surgery
- Patients unable to understand and speak English
- Patients requiring a revision or bilateral TJA
- Patients unwilling or unable to use a bluetooth-enabled smartphone with cell service or home internet access
- Incarceration
Key Trial Info
Start Date :
January 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04910048
Start Date
January 17 2022
End Date
September 3 2024
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UAMS Orthopaedic Clinic - Shackleford
Little Rock, Arkansas, United States, 72211