TERMINATED

Total Joint Arthroplasty (TJA) Weight Loss Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-10-03
Study Completion:2025-09-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05156762

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Patient must be interested in TJA as a treatment option
  3. * 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
  1. * Patient has undergone prior laparoscopic sleeve gastrectomy or gastric bypass
  2. * Patient has undergone prior hip or knee joint replacement for the affected joint
  3. * Active substance use disorder
  4. * Females with child-bearing potential

Contacts and Locations

Principal Investigator

David M Freccero, MD
PRINCIPAL_INVESTIGATOR
Boston Medical Center

Study Locations (Sites)

Boston Medical Center
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston Medical Center

  • David M Freccero, MD, PRINCIPAL_INVESTIGATOR, Boston Medical Center

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

Study Start Date2022-10-03
Study Completion Date2025-09-07

Study Record Updates

Study Start Date2022-10-03
Study Completion Date2025-09-07

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Osteoarthritis, Hip
  • Osteoarthritis, Knee
  • Obesity, Morbid