Osteoarthritis, Knee, Osteoarthritis, Hip, Avascular Necrosis, Rheumatoid Arthritis
Conditions
Keywords
Total joint arthroplasty, Hip arthroplasty, Knee arthroplasty, Surgical ineligibility, Obesity, Patient Reported Outcome Measures, TJA, THA, TKA, PROMs, BMI, HbA1c
Brief 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).
Interventions
OTHERPOPOP (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.
Referral to a dietician for two months of self-directed weight loss
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the interventions, masking or blinded participation is not possible.
Intervention model description
Two group randomized control trial comparing the intervention (POPOP) and standard of care (SOC).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of pre-operative BMI | Approximately 70-110 days from study enrollment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-operative health & nutritional status as assessed by change of albumin | Approximately 70-110 days from study enrollment | 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 |
| Pre-operative health & nutritional status as assessed by change of AST (aspartate aminotransferase) | Approximately 70-110 days from study enrollment | 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 |
| Pre-operative health & nutritional status as assessed by change of BUN (blood urea nitrogen) | Approximately 70-110 days from study enrollment | 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 |
| Change of pre-operative health & nutritional status as assessed by Creatinine | Approximately 70-110 days from study enrollment | 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 |
| Change of pre-operative type 2 diabetes as assessed by HbA1c (Hemaglobin A1c) laboratory test values | Approximately 70-110 days from study enrollment | Assessment of change in HbA1c (Hemaglobin A1c) between the date of enrollment to follow-up visit to occur between days 70-110 |
| Change of pre-operative inflammation as assessed by CRP (C-Reactive Protein) laboratory test values | Approximately 70-110 days from study enrollment | Assessment of change in CRP (C-Reactive Protein) between the date of enrollment to follow-up visit to occur between days 70-110 |
| Change of pre-operative PROMs (Knee Replacement) | Approximately 70-110 days from study enrollment | 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 |
| Change of pre-operative PROMs (Hip Replacement) | Approximately 70-110 days from study enrollment | 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 |
| Change of pre-operative PROMIS Pain Interference | Approximately 70-110 days from study enrollment | 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 |
| Change of pre-operative PROMIS Physical Function | Approximately 70-110 days from study enrollment | 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 |
| Pre-operative health & nutritional status as assessed by change of red blood cell count | Approximately 70-110 days from study enrollment | 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 |
| Pre-operative health & nutritional status as assessed by change of white blood cell count | Approximately 70-110 days from study enrollment | 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 |
| Pre-operative health & nutritional status as assessed by change of platelet count | Approximately 70-110 days from study enrollment | 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 |
| Pre-operative health & nutritional status as assessed by change of ALT (alanine aminotransferase) | Approximately 70-110 days from study enrollment | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of PROMs in the 6-weeks after knee replacement | Approximately 180 days from study enrollment (or 6 weeks after TJA) | Assessment of change in the patient reported outcomes survey KOOS Jr, for patients undergoing knee replacement |
| Change of PROMs in the 6-weeks after hip replacement | Approximately 180 days from study enrollment (or 6 weeks after TJA) | Assessment of change in the patient reported outcomes survey HOOS Jr, for patients undergoing hip replacement |
| Change of PROMIS Pain Interference in the 6-weeks after joint replacement | Approximately 180 days from study enrollment (or 6 weeks after TJA) | Assessment of change in PROMIS Pain Interference patient reported outcome instrument |
| Change of PROMIS Physical Function in the 6-weeks after joint replacement | Approximately 180 days from study enrollment (or 6 weeks after TJA) | Assessment of change in PROMIS Physical Function patient reported outcome instrument |
| All-cause complication rate at 30-days post TJA | Approximately 160 days from study enrollment (or 30 days after TJA) | Rate of surgical complications requiring hospital readmission, ER or acute care visit in 30 days after TJA |
| All-cause complication rate at 60-days post TJA | Approximately 190 days from study enrollment (or 60 days after TJA) | Rate of surgical complications requiring hospital readmission, ER or acute care visit in 60 days after TJA |
| All-cause complication rate at 90-days post TJA | Approximately 220 days from study enrollment (or 90 days after TJA) | Rate of surgical complications requiring hospital readmission, ER or acute care visit in 90 days after TJA |
| Percentage of patients who proceed to TJA | Approximately 110-120 days from study enrollment | Assessment of the percentage of patients that undergo TJA in each treatment group |
| Percentage of patients converting from ineligible to eligible status | Approximately 70-110 days from study enrollment | Assessment of the percentage of patients achieving a BMI of 40.0 kg/m2 or less in each treatment group |
Countries
United States
Outcome results
None listed