Weight loss options for patients needing joint replacement surgery
Optimizing the Body Mass Index: A Randomized Clinical Trial to Assess the Efficacy of Bariatric Surgery vs Medical Weight Loss in Morbidly Obese Patients Prior to Total Joint Arthroplasty
This study is testing whether bariatric surgery, medical weight loss, or standard care can help very overweight patients with severe hip or knee arthritis lose enough weight to safely have joint replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05156762 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial evaluates the effectiveness of bariatric surgery, medical weight loss, and the usual standard of care in helping morbidly obese patients with end-stage osteoarthritis of the hip or knee prepare for total joint arthroplasty (TJA). Participants will be monitored through regular visits and telemedicine consultations to track their weight loss progress. The primary goal is to determine which intervention leads to a BMI of 40 kg/m2 or lower, allowing patients to safely undergo TJA. The study also includes follow-up surveys to assess long-term weight management after surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a BMI over 40 kg/m2 who have osteoarthritis of the hip or knee and are interested in joint replacement surgery.
Not a fit: Patients who have previously undergone bariatric surgery or joint replacement for the affected joint may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective weight loss strategies that improve surgical outcomes for morbidly obese patients needing joint replacements.
How similar studies have performed: Previous studies have shown promising results with weight loss interventions in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Patient must be 18 years or older who has met the clinical/standard care criteria for TJA (patient must have exhausted conservative measures to treat hip or knee joint arthritis (NSAIDS, physical therapy, corticosteroid injections)), except patient has a BMI \> 40 kg/m2 * Patient must be interested in TJA as a treatment option * Patient must be willing to be randomized to either a bariatric surgery study arm, a medical weight loss study arm, or a "usual standard of care" study arm Exclusion Criteria: * Patient has undergone prior laparoscopic sleeve gastrectomy or gastric bypass * Patient has undergone prior hip or knee joint replacement for the affected joint * Active substance use disorder * Females with child-bearing potential
Where this trial is running
Boston, Massachusetts
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: David M Freccero, MD — Boston Medical Center
- Study coordinator: David M Freccero, MD
- Email: David.Freccero@bmc.org
- Phone: (617) 638-5633
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.