NCT04910048Completed
Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in TJA
Impact of a Preoperative Patient Optimization Program on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in Total Joint Arthroplasty
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 20 May 2021
- Start date
- 17 Jan 2022
- Primary completion date
- 1 Apr 2023
- Lead sponsor
- University of Arkansas
- Diseases
- Obesity, Rheumatoid arthritis
- NCT number
- NCT04910048
What you commit to
- Study type: Interventional
- Participants enrolled: 46
- From 17 Jan 2022 to the primary completion date, 1 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients scheduled for, or those who have previously undergone, bariatric surgery
Other illness
- History of a major organ transplant or other health issue requiring immunosuppressant drugs
- Diagnosis of and/or are taking medication for psychiatric conditions including schizophrenia, bipolar disorder or manic depression
Other
- Patients with a BMI less than 41.00 or greater than 48.00
- Pregnancy
- Breastfeeding
- Strict vegetarian diet
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UAMS Orthopaedic Clinic - Shackleford Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.