Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in TJA

Study Overview
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Brief Summary
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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
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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).

Official Title
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Impact of a Preoperative Patient Optimization Program on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in Total Joint Arthroplasty

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

Intervention / Treatment
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* Other: POPOP (preoperative patient optimization program)
* Other: SOC (standard of care)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two group randomized control trial comparing the intervention (POPOP) and standard of care (SOC).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>The first arm consists of UAMS standard of care (SOC), including providing a brochure with information (contact information, brief educational information) for the patient to consult with a nutritionist to help with self-directed weight loss. | Other: SOC (standard of care)<br>* Referral to a dietician for two months of self-directed weight loss<br>|
| Experimental: Intervention (POPOP)<br>The second arm is a specified 2-month POPOP focused on weight loss administered by the external partner, 20Lighter. The program includes customized meal plans; vitamin, mineral and nutritional supplementation; and daily engagement via a smartphone app with a 20Lighter health care provider. Video conferencing appointments will occur approximately every 3 weeks. The program does not require any exercise or physical engagement but does necessitate that patients have a smartphone or tablet with Bluetooth capability, cell signal or WIFI connection. During the first 40 days the customized meal plans are adhered to, then from days 41-60 patients will transition back to a normal dietary lifestyle via a customized plan based on considerations including, food preferences, physical engagement and height. Patients who achieve a BMI below 40.0 before the end of the 60 day program may be seen sooner than 90d for follow-up appointment in the UAMS clinic. | Other: POPOP (preoperative patient optimization program)<br>* 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.<br>* Other names: 20Lighter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Approximately 70-110 days from study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Approximately 70-110 days from study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total joint arthroplasty, Hip arthroplasty, Knee arthroplasty, Surgical ineligibility, Obesity, Patient Reported Outcome Measures, TJA, THA, TKA, PROMs, BMI, HbA1c