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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | 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. |
|
| Intervention (POPOP) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POPOP (preoperative patient optimization program) | Other | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients converting from ineligible to eligible status | Assessment of the percentage of patients achieving a BMI of 40.0 kg/m2 or less in each treatment group | Approximately 70-110 days from study enrollment |
| Percentage of patients who proceed to TJA |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey B Stambough, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS Orthopaedic Clinic - Shackleford | Little Rock | Arkansas | 72211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18722309 | Background | Bolognesi MP, Marchant MH Jr, Viens NA, Cook C, Pietrobon R, Vail TP. The impact of diabetes on perioperative patient outcomes after total hip and total knee arthroplasty in the United States. J Arthroplasty. 2008 Sep;23(6 Suppl 1):92-8. doi: 10.1016/j.arth.2008.05.012. | |
| 30778723 | Background | Boyce L, Prasad A, Barrett M, Dawson-Bowling S, Millington S, Hanna SA, Achan P. The outcomes of total knee arthroplasty in morbidly obese patients: a systematic review of the literature. Arch Orthop Trauma Surg. 2019 Apr;139(4):553-560. doi: 10.1007/s00402-019-03127-5. Epub 2019 Feb 16. |
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Individual participant data will not be shared. Statistics based on aggregated de-identified data will be assessed, and disseminated at industry conferences and peer-reviewed publication.
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Two group randomized control trial comparing the intervention (POPOP) and standard of care (SOC).
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Due to the nature of the interventions, masking or blinded participation is not possible.
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|
| SOC (standard of care) | Other | Referral to a dietician for two months of self-directed weight loss |
|
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 |
Assessment of the percentage of patients that undergo TJA in each treatment group |
| Approximately 110-120 days from study enrollment |
| Change of PROMs in the 6-weeks after knee replacement | Assessment of change in the patient reported outcomes survey KOOS Jr, for patients undergoing knee replacement | Approximately 180 days from study enrollment (or 6 weeks after TJA) |
| Change of PROMs in the 6-weeks after hip replacement | Assessment of change in the patient reported outcomes survey HOOS Jr, for patients undergoing hip replacement | Approximately 180 days from study enrollment (or 6 weeks after TJA) |
| Change of PROMIS Pain Interference in the 6-weeks after joint replacement | Assessment of change in PROMIS Pain Interference patient reported outcome instrument | Approximately 180 days from study enrollment (or 6 weeks after TJA) |
| Change of PROMIS Physical Function in the 6-weeks after joint replacement | Assessment of change in PROMIS Physical Function patient reported outcome instrument | Approximately 180 days from study enrollment (or 6 weeks after TJA) |
| All-cause complication rate at 30-days post TJA | Rate of surgical complications requiring hospital readmission, ER or acute care visit in 30 days after TJA | Approximately 160 days from study enrollment (or 30 days after TJA) |
| All-cause complication rate at 60-days post TJA | Rate of surgical complications requiring hospital readmission, ER or acute care visit in 60 days after TJA | Approximately 190 days from study enrollment (or 60 days after TJA) |
| All-cause complication rate at 90-days post TJA | Rate of surgical complications requiring hospital readmission, ER or acute care visit in 90 days after TJA | Approximately 220 days from study enrollment (or 90 days after TJA) |
| 33728201 | Background | Gerlach E, Selley R, Johnson D, Nicolay R, Versteeg G, Plantz M, Tjong V, Terry M. Patient-Reported Outcomes Measurement Information System Validation in Hip Arthroscopy: A Shift Towards Reducing Survey Burden. Cureus. 2021 Feb 10;13(2):e13265. doi: 10.7759/cureus.13265. |
| 31952945 | Background | Goodman SM, Mehta BY, Mandl LA, Szymonifka JD, Finik J, Figgie MP, Navarro-Millan IY, Bostrom MP, Parks ML, Padgett DE, McLawhorn AS, Antao VC, Yates AJ, Springer BD, Lyman SL, Singh JA. Validation of the Hip Disability and Osteoarthritis Outcome Score and Knee Injury and Osteoarthritis Outcome Score Pain and Function Subscales for Use in Total Hip Replacement and Total Knee Replacement Clinical Trials. J Arthroplasty. 2020 May;35(5):1200-1207.e4. doi: 10.1016/j.arth.2019.12.038. Epub 2019 Dec 27. |
| 33284982 | Background | Harold RE, Butler BA, Delagrammaticas D, Sullivan R, Stover M, Manning DW. Patient-Reported Outcomes Measurement Information System Correlates With Modified Harris Hip Score in Total Hip Arthroplasty. Orthopedics. 2021 Jan 1;44(1):e19-e25. doi: 10.3928/01477447-20201202-02. Epub 2020 Dec 7. |
| 33228699 | Background | Horn ME, Reinke EK, Couce LJ, Reeve BB, Ledbetter L, George SZ. Reporting and utilization of Patient-Reported Outcomes Measurement Information System(R) (PROMIS(R)) measures in orthopedic research and practice: a systematic review. J Orthop Surg Res. 2020 Nov 23;15(1):553. doi: 10.1186/s13018-020-02068-9. |
| 31436651 | Background | Keeney BJ, Austin DC, Jevsevar DS. Preoperative Weight Loss for Morbidly Obese Patients Undergoing Total Knee Arthroplasty: Determining the Necessary Amount. J Bone Joint Surg Am. 2019 Aug 21;101(16):1440-1450. doi: 10.2106/JBJS.18.01136. |
| 32501522 | Background | Lingamfelter M, Orozco FR, Beck CN, Harrer MF, Post ZD, Ong AC, Ponzio DY. Nutritional Counseling Program for Morbidly Obese Patients Enables Weight Optimization for Safe Total Joint Arthroplasty. Orthopedics. 2020 Jul 1;43(4):e316-e322. doi: 10.3928/01477447-20200521-08. Epub 2020 Jun 5. |
| 33178529 | Background | Shaka H, Ojemolon PE. Impact of Obesity on Outcomes of Patients With Hip Osteoarthritis Who Underwent Hip Arthroplasty. Cureus. 2020 Oct 10;12(10):e10876. doi: 10.7759/cureus.10876. |
| 32088050 | Background | Shapiro JA, Narayanan AS, Taylor PR, Olcott CW, Del Gaizo DJ. Fate of the Morbidly Obese Patient Who Is Denied Total Joint Arthroplasty. J Arthroplasty. 2020 Jun;35(6S):S124-S128. doi: 10.1016/j.arth.2020.01.071. Epub 2020 Feb 4. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C028380 | POPOP |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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