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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

Must not have

Patient has undergone prior laparoscopic sleeve gastrectomy or gastric bypass

Patient has undergone prior hip or knee joint replacement for the affected joint

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had weight loss surgery in the past.

Select...

I have had a hip or knee replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bariatric surgery to achieve a BMI ≤ 40 kg/m2

Medical weight loss to achieve a BMI ≤ 40 kg/m2

Secondary study objectives

24 month reoperation rate

24 month revision rate

90 day postoperative readmission rate

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~15190

0 / 2Eligibility criteria met