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Completed

NCT Number: NCT04910048

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Body Weight Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoarthritis Osteoarthritis, Hip Osteonecrosis Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAMS Orthopaedic Clinic - Shackleford

Little Rock, Arkansas, 72211, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 20Lighter

SOC (Standard of care)

Other

Referral to a dietician for two months of self-directed weight loss

Primary outcomes

  1. Change of pre-operative BMI

    Time frame: 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 outcomes

  1. Pre-operative health & nutritional status as assessed by change of red blood cell count

    Time frame: 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

  2. Pre-operative health & nutritional status as assessed by change of white blood cell count

    Time frame: 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

  3. Pre-operative health & nutritional status as assessed by change of platelet count

    Time frame: 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

  4. Pre-operative health & nutritional status as assessed by change of albumin

    Time frame: 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

  5. Pre-operative health & nutritional status as assessed by change of ALT (alanine aminotransferase)

    Time frame: 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

  6. Pre-operative health & nutritional status as assessed by change of AST (aspartate aminotransferase)

    Time frame: 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

  7. Pre-operative health & nutritional status as assessed by change of BUN (blood urea nitrogen)

    Time frame: 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

  8. Change of pre-operative health & nutritional status as assessed by Creatinine

    Time frame: 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

  9. Change of pre-operative type 2 diabetes as assessed by HbA1c (Hemaglobin A1c) laboratory test values

    Time frame: 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

  10. Change of pre-operative inflammation as assessed by CRP (C-Reactive Protein) laboratory test values

    Time frame: 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

  11. Change of pre-operative PROMs (Knee Replacement)

    Time frame: 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

  12. Change of pre-operative PROMs (Hip Replacement)

    Time frame: 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

  13. Change of pre-operative PROMIS Pain Interference

    Time frame: 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

  14. Change of pre-operative PROMIS Physical Function

    Time frame: 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

Other outcomes

  1. Percentage of patients converting from ineligible to eligible status

    Time frame: 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

  2. Percentage of patients who proceed to TJA

    Time frame: Approximately 110-120 days from study enrollment

    Assessment of the percentage of patients that undergo TJA in each treatment group

  3. Change of PROMs in the 6-weeks after knee replacement

    Time frame: 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

  4. Change of PROMs in the 6-weeks after hip replacement

    Time frame: 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

  5. Change of PROMIS Pain Interference in the 6-weeks after joint replacement

    Time frame: Approximately 180 days from study enrollment (or 6 weeks after TJA)

    Assessment of change in PROMIS Pain Interference patient reported outcome instrument

  6. Change of PROMIS Physical Function in the 6-weeks after joint replacement

    Time frame: Approximately 180 days from study enrollment (or 6 weeks after TJA)

    Assessment of change in PROMIS Physical Function patient reported outcome instrument

  7. All-cause complication rate at 30-days post TJA

    Time frame: 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

  8. All-cause complication rate at 60-days post TJA

    Time frame: 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

  9. All-cause complication rate at 90-days post TJA

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 2, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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