Total Joint Arthroplasty (TJA) Weight Loss Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Obesity, Morbid; Osteoarthritis, Hip
• Intervention / Treatment: Procedure: Bariatric surgery; Other: Patient research surveys; Procedure: Total joint arthroplasty (TJA); Behavioral: Medical weight loss; Other: Usual standard of care

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.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David M Freccero, MD; Phone Number: (617) 638-5633; Email: David.Freccero@bmc.org
• Study Contact Backup: Name: Christopher A Worgul, MD; Phone Number: (860) 917-4468; Email: Christopher.Worgul@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Contact: David M Freccero, MD; Phone Number: 617-638-5633

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bariatric surgery group; 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.	Procedure: Bariatric surgery; Patients randomized to the bariatric surgery study arm will undergo either a laparoscopic sleeve gastrectomy or a laparoscopic gastric bypass - this decision would be a joint decision made between the study participant and the bariatric surgeon after consideration of the patient's overall goals with weight loss and discussion of the risks and benefits of each procedure.; Other: Patient research surveys; Patients will have a telemedicine visit every 3 months with an orthopaedic surgery physician assistant to review their latest BMI and to complete a patient research survey to assess the patient's feelings regarding their progress. The telemedicine visits every 3 months are unique to the clinical trial and these visits would not otherwise occur if the patient was not enrolled in the trial. If patients are found to not be advancing toward the BMI goal of ≤ 40 kg/m2, these patient research surveys can be used to make individualized adjustments, based on recommendations from dieticians and the medical nutritionist.; Procedure: Total joint arthroplasty (TJA); Once the study participant meets the target BMI goal of ≤ 40 kg/m2, they will undergo TJA. Patients will be followed for 2 years after undergoing TJA.
Experimental: Medical weight loss group; 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.	Other: Patient research surveys; Patients will have a telemedicine visit every 3 months with an orthopaedic surgery physician assistant to review their latest BMI and to complete a patient research survey to assess the patient's feelings regarding their progress. The telemedicine visits every 3 months are unique to the clinical trial and these visits would not otherwise occur if the patient was not enrolled in the trial. If patients are found to not be advancing toward the BMI goal of ≤ 40 kg/m2, these patient research surveys can be used to make individualized adjustments, based on recommendations from dieticians and the medical nutritionist.; Procedure: Total joint arthroplasty (TJA); Once the study participant meets the target BMI goal of ≤ 40 kg/m2, they will undergo TJA. Patients will be followed for 2 years after undergoing TJA.; Behavioral: Medical weight loss; Study participants randomized to the medical weight loss study arm will have consultations with nutritionists, dieticians, and endocrinologists, and will make dietary and lifestyle changes in an effort to lower their BMI to ≤ 40 kg/m2. Patients may also be placed on pharmacotherapy to assist with weight loss.
Other: "Usual Standard of Care"; 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.	Procedure: Total joint arthroplasty (TJA); Once the study participant meets the target BMI goal of ≤ 40 kg/m2, they will undergo TJA. Patients will be followed for 2 years after undergoing TJA.; Other: Usual standard of care; 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. They will be urged to make an appointment or to seek any other interventions they choose to help lower their BMI, but no appointments will be made for them. A follow up visit in 6 months and 1 year will be made for them in the arthroplasty clinic to reassess their progress. Referral information will again be provided at 6 months if no progress has been made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bariatric surgery to achieve a BMI ≤ 40 kg/m2	The number of patients who are able to achieve a BMI ≤ 40 kg/m2 prior to total joint arthroplasty (TJA) will be analyzed.	12 months
Medical weight loss to achieve a BMI ≤ 40 kg/m2	The number of patients who are able to achieve a BMI ≤ 40 kg/m2 prior to total joint arthroplasty (TJA) will be analyzed.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in body weight	The percentage change in body weight lost will be calculated from baseline to TJA	Baseline, day of TJA
Total TJA operative time	The total number of minutes will be abstracted from the operative report	Day of surgery
Length of hospital stay for TJA procedure	The total number of days will be abstracted from the electronic health record (EHR).	Day of surgery until discharge from hospital, up to 7 days
Surgical site infection rate	The proportion of participants who develop a postoperative surgical site infection	90 days after TJA
Venous thromboembolism rate	The proportion of participants who develop a postoperative deep venous thrombosis	90 days after TJA
Hematoma rate	The proportion of participants who develop a postoperative hematoma	90 days after TJA
Urinary tract infection rate	The proportion of participants who develop a postoperative urinary tract infection	90 days after TJA
Cardiac event rate	The proportion of participants who have a postoperative cardiac event	90 days after TJA
Prosthetic joint infection rate	The proportion of participants who have a postoperative prosthetic joint infection	90 days after TJA
90 day postoperative readmission rate	The rate of hospital readmission 90 days after TJA	90 days after TJA
24 month revision rate	Need for total hip or total knee arthroplasty component revision after primary total hip or total knee arthroplasty	24 months
24 month reoperation rate	Need for reoperation for reasons other than component failure (surgical site infection, tendon injury) after primary total hip or total knee arthroplasty	24 months
Maintained a BMI ≤ 40 kg/m2 post TJA	The number of participants who maintained a BMI ≤ 40 kg/m2 for 24 months	24 months post TJA
Change in patient satisfaction with weight loss procedure	An investigator developed questionnaire will ask a question about how satisfied participants are with the weight loss procedure used from very satisfied to not at all satisfied.	Baseline, 24 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: David M Freccero, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Bariatric surgery; Total Knee Arthroplasty (TKA); Total Hip Arthroplasty (THA); Prosthetic Joint Infection; Medical weight loss; Total Joint Arthroplasty (TJA); Body Mass Index >40 kg/m2
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Body Weight Changes; Obesity; Osteoarthritis; Osteoarthritis, Knee; Weight Loss; Obesity, Morbid; Osteoarthritis, Hip
• Other Study ID Numbers: H-41295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No