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Procedure
Weight Loss Strategies for Osteoarthritis
N/A
Recruiting
Led By David M Freccero, MD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will compare bariatric surgery, medical weight loss, and usual standard of care to optimize morbidly obese patients with end-stage osteoarthritis of the hip or knee joint for total joint arthroplasty.
Who is the study for?
This trial is for adults with severe hip or knee osteoarthritis and obesity (BMI > 40 kg/m2) who have tried other treatments without success. They must be considering total joint replacement surgery but haven't had previous replacements in the affected joints, no active substance use disorders, and not be pregnant.Check my eligibility
What is being tested?
The study compares three approaches to help morbidly obese patients prepare for joint replacement surgery: bariatric surgery, medical weight loss programs, and usual care. It aims to see which method is best at reducing BMI to ≤ 40 kg/m2 before surgery.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks like infection or bleeding from bariatric surgery; nutritional deficiencies; gastrointestinal symptoms from medical weight loss methods; and general discomfort from surveys.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bariatric surgery to achieve a BMI ≤ 40 kg/m2
Medical weight loss to achieve a BMI ≤ 40 kg/m2
Secondary outcome measures
24 month reoperation rate
24 month revision rate
90 day postoperative readmission rate
+11 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Medical weight loss groupExperimental Treatment3 Interventions
Participants randomized to the medical weight loss study arm will attempt to lose weight through diet, exercise, and potentially pharmacotherapy an effort to lower their BMI to ≤ 40 kg/m2.
Group II: Bariatric surgery groupExperimental Treatment3 Interventions
Participants randomized to the bariatric surgery arm will undergo either a laparoscopic sleeve gastrectomy or a laparoscopic gastric bypass to achieve a BMI ≤ 40 kg/m2.
Group III: "Usual Standard of Care"Experimental Treatment2 Interventions
Patients randomized to the "usual standard of care" study arm will be counseled on the importance of losing weight to optimize their BMI and will be provided with referral information (name and clinic number) to either the bariatric surgery or medical weight loss clinics.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bariatric surgery
2013
Completed Phase 4
~15460
Find a Location
Who is running the clinical trial?
Boston Medical CenterLead Sponsor
383 Previous Clinical Trials
871,012 Total Patients Enrolled
16 Trials studying Obesity
67,424 Patients Enrolled for Obesity
David M Freccero, MDPrincipal InvestigatorBoston Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18, have severe hip or knee arthritis, tried all other treatments, and my BMI is over 40.I am a woman who can become pregnant.I am open to being assigned to any type of weight loss treatment group in the study.I have had weight loss surgery in the past.I am considering total joint replacement surgery.I have had a hip or knee replacement surgery.You are currently addicted to drugs or alcohol.
Research Study Groups:
This trial has the following groups:- Group 1: "Usual Standard of Care"
- Group 2: Bariatric surgery group
- Group 3: Medical weight loss group
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.
What is the highest possible participant count for this experiment?
"Correct. All information available from clinicaltrials.gov indicates that this medical study is currently recruiting volunteers, having been first posted on October 3rd 2022 and recently updated on the 28th of the same month. This trial requires 138 participants to be recruited at a single location."
Answered by AI
What is the primary aim of this investigation?
"The primary aim of this year-long trial is to attain a BMI ≤ 40 kg/m2 through bariatric surgery. Secondary endpoints being evaluated include prosthetic joint infection rate, total TJA operative time, and the percentage change in body weight from baseline to postoperative results."
Answered by AI
Is there still an opportunity for people to volunteer for this experiment?
"Clinicaltrials.gov divulges that this research, which was first posted on October 3rd 2022, is actively looking for participants. The trial's particulars were last revised on the 28th of October in the same year."
Answered by AI
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