Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in TJA
NCT04910048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2024-09-19
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.
Conditions
- Osteoarthritis, Knee
- Osteoarthritis, Hip
- Avascular Necrosis
- Rheumatoid Arthritis
Interventions
- OTHER
-
POPOP (preoperative patient optimization program)
A 2 month structured program focused on reduction of BMI, body weight, visceral fat, body fat and improvement of lean body mass and intracellular fluid.
- OTHER
-
SOC (standard of care)
Referral to a dietician for two months of self-directed weight loss
Sponsors & Collaborators
-
University of Arkansas
lead OTHER
Principal Investigators
-
Jeffrey B Stambough, MD · University of Arkansas
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-17
- Primary Completion
- 2023-04-01
- Completion
- 2024-09-03
Countries
- United States
Study Locations
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