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

August 29, 2024 updated by: University of Arkansas

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Approximately 70-110 days from study enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment
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
Approximately 70-110 days from study enrollment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Approximately 70-110 days from study enrollment
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
Approximately 110-120 days from study enrollment
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
Approximately 180 days from study enrollment (or 6 weeks after TJA)
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
Approximately 180 days from study enrollment (or 6 weeks after TJA)
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
Approximately 180 days from study enrollment (or 6 weeks after TJA)
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
Approximately 180 days from study enrollment (or 6 weeks after TJA)
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
Approximately 160 days from study enrollment (or 30 days after TJA)
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
Approximately 190 days from study enrollment (or 60 days after TJA)
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
Approximately 220 days from study enrollment (or 90 days after TJA)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arkansas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey B Stambough, MD, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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