Total Joint Arthroplasty (TJA) Weight Loss Study

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05156762
• Other study ID #: H-41295
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: November 2026

Study information

• Verified date: October 2023
• Source: Boston Medical Center
• Contact: David M Freccero, MD
• Phone: (617) 638-5633
• Email: David.Freccero[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Weight Loss

Intervention

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.

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.

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage change in body weight	The percentage change in body weight lost will be calculated from baseline to TJA	Baseline, day of TJA
Secondary	Total TJA operative time	The total number of minutes will be abstracted from the operative report	Day of surgery
Secondary	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
Secondary	Surgical site infection rate	The proportion of participants who develop a postoperative surgical site infection	90 days after TJA
Secondary	Venous thromboembolism rate	The proportion of participants who develop a postoperative deep venous thrombosis	90 days after TJA
Secondary	Hematoma rate	The proportion of participants who develop a postoperative hematoma	90 days after TJA
Secondary	Urinary tract infection rate	The proportion of participants who develop a postoperative urinary tract infection	90 days after TJA
Secondary	Cardiac event rate	The proportion of participants who have a postoperative cardiac event	90 days after TJA
Secondary	Prosthetic joint infection rate	The proportion of participants who have a postoperative prosthetic joint infection	90 days after TJA
Secondary	90 day postoperative readmission rate	The rate of hospital readmission 90 days after TJA	90 days after TJA
Secondary	24 month revision rate	Need for total hip or total knee arthroplasty component revision after primary total hip or total knee arthroplasty	24 months
Secondary	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
Secondary	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
Secondary	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