Total Joint Arthroplasty (TJA) Weight Loss Study

Boston Medical Center (BMC)

Status: Terminated

Conditions: Osteoarthritis, Hip; Obesity, Morbid; Osteoarthritis, Knee

Treatments: Behavioral: Medical weight loss; Other: Usual standard of care; Other: Patient research surveys; Procedure: Total joint arthroplasty (TJA); Procedure: Bariatric surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05156762

H-41295

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 3 patient groups

Bariatric surgery group

Experimental group

Description:

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.

Treatment:

Procedure: Bariatric surgery

Procedure: Total joint arthroplasty (TJA)

Other: Patient research surveys

Medical weight loss group

Experimental group

Description:

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.

Treatment:

Procedure: Total joint arthroplasty (TJA)

Other: Patient research surveys

Behavioral: Medical weight loss

"Usual Standard of Care"

Other group

Description:

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:

Other: Usual standard of care

Procedure: Total joint arthroplasty (TJA)