NCT04910048

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 will be randomized into one of two groups: Standard of Care or the POPOP (20Lighter).

Conditions

• Osteoarthritis, Knee
• Osteoarthritis, Hip
• Avascular Necrosis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-17
• Primary completion: 2023-04-01
• Completion: 2024-09-03
• First posted: 2021-06-02
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States