Clinical trial NCT04910048: Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in TJA
Official title: Impact of a Preoperative Patient Optimization Program on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Avascular Necrosis
Rheumatoid Arthritis
Keywords: Total joint arthroplasty
Hip arthroplasty
Knee arthroplasty
Surgical ineligibility
Obesity
Patient Reported Outcome Measures
TJA
THA
TKA
PROMs
BMI
HbA1c
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomized control trial comparing the intervention (POPOP) and standard of care (SOC).
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change of pre-operative BMI
timeFrame: Approximately 70-110 days from study enrollment
Secondary outcomes:
measure: Pre-operative health & nutritional status as assessed by change of red blood cell count
timeFrame: Approximately 70-110 days from study enrollment
measure: Pre-operative health & nutritional status as assessed by change of white blood cell count
timeFrame: Approximately 70-110 days from study enrollment
measure: Pre-operative health & nutritional status as assessed by change of platelet count
timeFrame: Approximately 70-110 days from study enrollment
measure: Pre-operative health & nutritional status as assessed by change of albumin
timeFrame: Approximately 70-110 days from study enrollment
measure: Pre-operative health & nutritional status as assessed by change of ALT (alanine aminotransferase)
timeFrame: Approximately 70-110 days from study enrollment
measure: Pre-operative health & nutritional status as assessed by change of AST (aspartate aminotransferase)
timeFrame: Approximately 70-110 days from study enrollment
measure: Pre-operative health & nutritional status as assessed by change of BUN (blood urea nitrogen)
timeFrame: Approximately 70-110 days from study enrollment
measure: Change of pre-operative health & nutritional status as assessed by Creatinine
timeFrame: Approximately 70-110 days from study enrollment
measure: Change of pre-operative type 2 diabetes as assessed by HbA1c (Hemaglobin A1c) laboratory test values
timeFrame: Approximately 70-110 days from study enrollment
measure: Change of pre-operative inflammation as assessed by CRP (C-Reactive Protein) laboratory test values
timeFrame: Approximately 70-110 days from study enrollment
measure: Change of pre-operative PROMs (Knee Replacement)
timeFrame: Approximately 70-110 days from study enrollment
measure: Change of pre-operative PROMs (Hip Replacement)
timeFrame: Approximately 70-110 days from study enrollment
measure: Change of pre-operative PROMIS Pain Interference
timeFrame: Approximately 70-110 days from study enrollment
measure: Change of pre-operative PROMIS Physical Function
timeFrame: Approximately 70-110 days from study enrollment
Other outcomes:
measure: Percentage of patients converting from ineligible to eligible status
timeFrame: Approximately 70-110 days from study enrollment
measure: Percentage of patients who proceed to TJA
timeFrame: Approximately 110-120 days from study enrollment
measure: Change of PROMs in the 6-weeks after knee replacement
timeFrame: Approximately 180 days from study enrollment (or 6 weeks after TJA)
measure: Change of PROMs in the 6-weeks after hip replacement
timeFrame: Approximately 180 days from study enrollment (or 6 weeks after TJA)
measure: Change of PROMIS Pain Interference in the 6-weeks after joint replacement
timeFrame: Approximately 180 days from study enrollment (or 6 weeks after TJA)
measure: Change of PROMIS Physical Function in the 6-weeks after joint replacement
timeFrame: Approximately 180 days from study enrollment (or 6 weeks after TJA)
measure: All-cause complication rate at 30-days post TJA
timeFrame: Approximately 160 days from study enrollment (or 30 days after TJA)
measure: All-cause complication rate at 60-days post TJA
timeFrame: Approximately 190 days from study enrollment (or 60 days after TJA)
measure: All-cause complication rate at 90-days post TJA
timeFrame: Approximately 220 days from study enrollment (or 90 days after TJA)
Locations:
city: Little Rock
country: United States
facility: UAMS Orthopaedic Clinic - Shackleford
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Jeffrey B Stambough, MD
role: PRINCIPAL_INVESTIGATOR
References:
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