Clinical trial NCT05156762: Total Joint Arthroplasty (TJA) Weight Loss Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Osteoarthritis, Knee
Obesity, Morbid
Keywords: Bariatric surgery
Medical weight loss
Total Hip Arthroplasty (THA)
Total Knee Arthroplasty (TKA)
Total Joint Arthroplasty (TJA)
Body Mass Index >40 kg/m2
Prosthetic Joint Infection
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Bariatric surgery to achieve a BMI ≤ 40 kg/m2
timeFrame: 12 months
measure: Medical weight loss to achieve a BMI ≤ 40 kg/m2
timeFrame: 12 months
Secondary outcomes:
measure: Percentage change in body weight
timeFrame: Baseline, day of TJA
measure: Total TJA operative time
timeFrame: Day of surgery
measure: Length of hospital stay for TJA procedure
timeFrame: Day of surgery until discharge from hospital, up to 7 days
measure: Surgical site infection rate
timeFrame: 90 days after TJA
measure: Venous thromboembolism rate
timeFrame: 90 days after TJA
measure: Hematoma rate
timeFrame: 90 days after TJA
measure: Urinary tract infection rate
timeFrame: 90 days after TJA
measure: Cardiac event rate
timeFrame: 90 days after TJA
measure: Prosthetic joint infection rate
timeFrame: 90 days after TJA
measure: 90 day postoperative readmission rate
timeFrame: 90 days after TJA
measure: 24 month revision rate
timeFrame: 24 months
measure: 24 month reoperation rate
timeFrame: 24 months
measure: Maintained a BMI ≤ 40 kg/m2 post TJA
timeFrame: 24 months post TJA
measure: Change in patient satisfaction with weight loss procedure
timeFrame: Baseline, 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: David M Freccero, MD
role: PRINCIPAL_INVESTIGATOR
References: