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Preoperative Optimization Program for Osteoarthritis
N/A
Waitlist Available
Led By Jeffrey B Stambough, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Over the age of 18 years
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 110-120 days from study enrollment
Awards & highlights
Study Summary
This trial will test whether a weight-loss program can help people who are ineligible for orthopedic surgery due to their weight to improve their health and reach a BMI threshold that would make them eligible for the surgery.
Who is the study for?
This trial is for adults over 18 with severe knee or hip joint issues (like osteoarthritis, avascular necrosis, or rheumatoid arthritis) who need a joint replacement but have a BMI between 41-48. Participants must be considering surgery if they become eligible and own a smartphone or tablet with internet access. It's not for those outside the BMI range, pregnant/breastfeeding individuals, major organ transplant recipients on immunosuppressants, strict vegetarians, people with certain psychiatric conditions, anyone scheduled for/with past bariatric surgery, non-English speakers, those needing complex joint replacements or without internet-capable devices.Check my eligibility
What is being tested?
The study compares a preoperative patient optimization program (POPOP) against standard care to see if POPOP helps patients improve their health before surgery so they can qualify for hip or knee replacement by reaching an acceptable weight (BMI <40). The focus is on whether this approach leads to better surgical eligibility and outcomes post-surgery.See study design
What are the potential side effects?
Since this trial involves a preoperative optimization program rather than medication or invasive procedures directly administered to participants during the study period itself; specific side effects are not detailed as part of the intervention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
Select...
I am recommended for a knee or hip replacement due to severe arthritis or avascular necrosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 110-120 days from study enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 110-120 days from study enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change of pre-operative BMI
Secondary outcome measures
Change of pre-operative PROMIS Pain Interference
Change of pre-operative PROMIS Physical Function
Change of pre-operative PROMs (Hip Replacement)
+11 moreOther outcome measures
All-cause complication rate at 30-days post TJA
All-cause complication rate at 60-days post TJA
All-cause complication rate at 90-days post TJA
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention (POPOP)Experimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control1 Intervention
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.
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Who is running the clinical trial?
University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,307 Total Patients Enrolled
5 Trials studying Osteoarthritis
14,488 Patients Enrolled for Osteoarthritis
Jeffrey B Stambough, MDPrincipal InvestigatorUniversity of Arkansas
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for or have had bariatric surgery.I cannot understand or speak English.I cannot or will not use a smartphone with internet for the study.I have had a major organ transplant or need drugs to suppress my immune system.I need a second surgery or surgery on both joints.I have been diagnosed with or am taking medication for a psychiatric condition like schizophrenia or bipolar disorder.I am over 18 years old.I am open to having joint replacement surgery if I qualify.I am recommended for a knee or hip replacement due to severe arthritis or avascular necrosis.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention (POPOP)
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the required criteria for enrollment in this medical study?
"Interested parties that are diagnosed with rheumatoid arthritis and between the ages of 18-80 can apply to join this trial. The team is looking for approximately 70 participants."
Answered by AI
Is there still an opportunity for individuals to participate in this experiment?
"Clinicaltrials.gov provides evidence that this study is in need of willing participants, having been first posted on January 17th 2022 and revised lastly on the 21st."
Answered by AI
Are persons under 35 years of age permitted to participate in this experiment?
"The parameters for patient eligibility are those between 18 and 80 years old. This study has 61 trials focusing on younger individuals, while 889 research initiatives focus on elderly participants."
Answered by AI
How many participants are allowed to join this research endeavor?
"Correct. According to the information posted on clinicaltrials.gov, this medical trial is actively recruiting patients that meet its eligibility criteria and has been since it was first published in January 17th 2022. 70 participants from 1 sites need to be recruited for successful completion of the study."
Answered by AI
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