Total Joint Arthroplasty (TJA) Weight Loss Study

Phase

N/A

Condition

Osteoarthritis

Diabetes Prevention

Weight Loss

Treatment

Patient research surveys

Medical weight loss

Usual standard of care

Clinical Study ID

NCT05156762

H-41295

Ages > 18
All Genders

Study Summary

This is a randomized clinical trial (RCT) to assess the efficacy of bariatric surgery vs medical weight loss vs. the "usual standard of care" to optimize a morbidly obese patient with end-stage osteoarthritis of the hip or knee joint for total joint arthroplasty (TJA).

The study population will include patients with hip or knee joint osteoarthritis and BMI (Body Mass Index) > 40 kg/m2 who are evaluated in the joint arthroplasty clinic at Boston Medical Center.

The primary objective of the study is to determine if bariatric surgery or medical weight loss is more effective than the usual standard of care in optimizing a morbidly obese patient with osteoarthritis of the hip or knee joint for TJA. This will be determined by comparing the number of patients within each group who are able to lose weight through either bariatric surgery, medical weight loss, or the usual standard of care to achieve a BMI ≤ 40 kg/m2 to eventually undergo TJA.

The secondary objectives of this study are to compare total operative time, postoperative complication rates, readmission rates, percentage of total body weight lost, revision rate, and reoperation rate. The ability of patients within each study arm to maintain a BMI ≤ 40 kg/m2 for up to 2 years after undergoing TJA will also be assessed, as well as their level of satisfaction before and after being in the study.

Eligibility Criteria

Inclusion

Inclusion criteria:

Patient must be 18 years or older who has met the clinical/standard care criteriafor TJA (patient must have exhausted conservative measures to treat hip or kneejoint arthritis (NSAIDS, physical therapy, corticosteroid injections)), exceptpatient 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, amedical weight loss study arm, or a "usual standard of care" study arm

Exclusion

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

Study Design

Patient research surveys

October 03, 2022

September 07, 2025

Study Description

In this prospective RCT, eligible participants will be randomized to one of three arms - the bariatric surgery study arm, the medical weight loss study arm, or the "usual standard of care" study arm. Each patient's progress will be monitored during visits by study personnel. Participants will also have telemedicine visits with an arthroplasty physician assistant every 3 months to ensure they are making progress in terms of weight loss and becoming a safer candidate for TJA. Participants will complete research surveys every 3 months during the telemedicine visits to provide feedback regarding their progress and weight loss methods.

After the study participant has achieved a BMI ≤ 40 kg/m2, they will undergo TJA and will be seen postoperatively in the arthroplasty clinic for routine follow up visits. Patients will continue to complete patient research surveys every 3 months via telemedicine for up to 2 years to provide feedback regarding how they are managing with their weight loss after undergoing TJA.

Connect with a study center

Boston Medical Center
Boston, Massachusetts 02118
United States
Site Not Available
Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
United States
Site Not Available

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