Total Joint Arthroplasty (TJA) Weight Loss Study

Sponsor

Boston Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05156762

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a randomized clinical trial (RCT) to assess the efficacy of bariatric surgery vs medical weight loss 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 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 or medical weight loss 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Hip Osteoarthritis, Knee Obesity, Morbid	Procedure: Bariatric surgery Behavioral: Medical weight loss Other: Patient research surveys Procedure: Total joint arthroplasty (TJA)	N/A

Detailed Description

In this prospective RCT, eligible participants will be randomized to undergo either the bariatric surgery or medical weight loss intervention and their progress will be monitored during visits by registered dieticians and medical nutritionists. 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 overall satisfaction with their weight loss and if any individualized changes need to be made.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2026

Anticipated Study Completion Date :

Nov 1, 2026

Arms and Interventions

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.	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: 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.

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.

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: Patient research surveys

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage change in body weight [Baseline, day of TJA]
The percentage change in body weight lost will be calculated from baseline to TJA
Total TJA operative time [Day of surgery]
The total number of minutes will be abstracted from the operative report
Length of hospital stay for TJA procedure [Day of surgery until discharge from hospital, up to 7 days]
The total number of days will be abstracted from the electronic health record (EHR).
Surgical site infection rate [90 days after TJA]
The proportion of participants who develop a postoperative surgical site infection
Venous thromboembolism rate [90 days after TJA]
The proportion of participants who develop a postoperative deep venous thrombosis
Hematoma rate [90 days after TJA]
The proportion of participants who develop a postoperative hematoma
Urinary tract infection rate [90 days after TJA]
The proportion of participants who develop a postoperative urinary tract infection
Cardiac event rate [90 days after TJA]
The proportion of participants who have a postoperative cardiac event
Prosthetic joint infection rate [90 days after TJA]
The proportion of participants who have a postoperative prosthetic joint infection
90 day postoperative readmission rate [90 days after TJA]
The rate of hospital readmission 90 days after TJA
24 month revision rate [24 months]
Need for total hip or total knee arthroplasty component revision after primary total hip or total knee arthroplasty
24 month reoperation rate [24 months]
Need for reoperation for reasons other than component failure (surgical site infection, tendon injury) after primary total hip or total knee arthroplasty
Maintained a BMI ≤ 40 kg/m2 post TJA [24 months post TJA]
The number of participants who maintained a BMI ≤ 40 kg/m2 for 24 months
Change in patient satisfaction with weight loss procedure [Baseline, 24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient must have a BMI > 40 kg/m2
Patient must have radiographic evidence of hip or knee joint arthritis
Patient must have exhausted conservative measures to treat hip or knee joint arthritis (NSAIDS, physical therapy, corticosteroid injections) and be interested in TJA as a treatment option
Patient must be willing to be randomized to either the bariatric surgery program or the medical weight loss program
Patient must be able to consent for him or herself or have a legal representative who can attest that the patient fully understands the purpose, risks, benefits, and alternatives of the study

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