Total Joint Arthroplasty (TJA) Weight Loss Study
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.
Conditions:
🦠 Osteoarthritis, Hip 🦠 Osteoarthritis, Knee 🦠 Obesity, Morbid
🗓️ Study Start (Actual) 3 October 2022
🗓️ Primary Completion (Estimated) November 2026
✅ Study Completion (Estimated) November 2026
👥 Enrollment (Estimated) 138
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 December 2021
  • First Submitted that Met QC Criteria 13 December 2021
  • First Posted 14 December 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 October 2023
  • Last Update Posted 10 October 2023
  • Last Verified October 2023