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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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.
Referral to a dietician for two months of self-directed weight loss
UAMS Orthopaedic Clinic - Shackleford
Little Rock, Arkansas, United States
Change of pre-operative BMI
Assessment of mean change in BMI (Body Mass Index, kg/m2) between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of red blood cell count
Change of values in red blood cells as assessed by (Complete Blood Count) between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of white blood cell count
Change of values in white blood cells as assessed by CBC (Complete Blood Count) between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of platelet count
Change of values in platelets as assessed by CBC (Complete Blood Count) between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of albumin
Change of values in Albumin as assessed by CMP (Comprehensive Metabolic Panel) between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of ALT (alanine aminotransferase)
Change of values in ALT (alanine aminotransferase) as assessed by CMP (Comprehensive Metabolic Panel) between the date of enrollment to follow-up visit to occur between days 70-110
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Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of AST (aspartate aminotransferase)
Change of values in AST (aspartate aminotransferase) as assessed by CMP (Comprehensive Metabolic Panel) between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of BUN (blood urea nitrogen)
Change of values in BUN (blood urea nitrogen) as assessed by CMP (Comprehensive Metabolic Panel) between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative health & nutritional status as assessed by Creatinine
Change of values in Creatinine as assessed by CMP (Comprehensive Metabolic Panel) between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative type 2 diabetes as assessed by HbA1c (Hemaglobin A1c) laboratory test values
Assessment of change in HbA1c (Hemaglobin A1c) between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative inflammation as assessed by CRP (C-Reactive Protein) laboratory test values
Assessment of change in CRP (C-Reactive Protein) between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative PROMs (Knee Replacement)
Assessment of change in the patient reported outcomes survey KOOS Jr, knee replacement patients between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative PROMs (Hip Replacement)
Assessment of change in the patient reported outcomes survey HOOS Jr, hip replacement patients between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative PROMIS Pain Interference
Assessment of change in PROMIS Pain Interference patient reported outcome instrument between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative PROMIS Physical Function
Assessment of change in PROMIS Physical Function patient reported outcome instrument between the date of enrollment to follow-up visit to occur between days 70-110
Time frame: Approximately 70-110 days from study enrollment