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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04910048
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Arkansas
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jeffrey B Stambough, MD
Principal Investigator Affiliation University of Arkansas
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Knee, Osteoarthritis, Hip, Avascular Necrosis, Rheumatoid Arthritis
Additional Details

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).

Arms & Interventions

Arms

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.

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.

Interventions

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: - SOC (standard of care)

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UAMS Orthopaedic Clinic - Shackleford, Little Rock, Arkansas

Status

Recruiting

Address

UAMS Orthopaedic Clinic - Shackleford

Little Rock, Arkansas, 72211

Site Contact

Principal Investigator

[email protected]

501-686-7812

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