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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis; Osteoarthritis, Knee; Avascular Necrosis; Osteoarthritis, Hip
• Intervention / Treatment: Other: SOC (standard of care); Other: POPOP (preoperative patient optimization program)

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).

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • UAMS Orthopaedic Clinic - Shackleford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; 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); Referral to a dietician for two months of self-directed weight loss
Experimental: Intervention (POPOP); 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); 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 Names: 20Lighter

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Jeffrey B Stambough, MD, University of Arkansas

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Estimated): December 23, 2024

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; HbA1c; THA; BMI; Knee arthroplasty; Hip arthroplasty; Patient Reported Outcome Measures; PROMs; TKA; Total joint arthroplasty; Surgical ineligibility; TJA
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Necrosis; Osteoarthritis, Hip
• Other Study ID Numbers: 262790

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No