Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes i… (NCT04910048) | Clinical Trial Compass
CompletedNot Applicable
Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in TJA
United States46 participantsStarted 2022-01-17
Plain-language 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 to reach a BMI threshold \<40 kg/m2 required for surgical eligibility, and postoperative outcomes versus SOC.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Change of pre-operative BMI
Timeframe: Approximately 70-110 days from study enrollment