Total Joint Arthroplasty (TJA) Weight Loss Study
- Conditions
- Osteoarthritis, KneeOsteoarthritis, HipObesity, Morbid
- Interventions
- Behavioral: Medical weight lossProcedure: Bariatric surgeryOther: Usual standard of careOther: Patient research surveysProcedure: Total joint arthroplasty (TJA)
- Registration Number
- NCT05156762
- Lead Sponsor
- Boston Medical Center
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 138
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bariatric surgery group Total joint arthroplasty (TJA) 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. Medical weight loss group Medical weight loss 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. Bariatric surgery group Bariatric surgery 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. Medical weight loss group Total joint arthroplasty (TJA) 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. "Usual Standard of Care" 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. Bariatric surgery group Patient research surveys 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. Medical weight loss group Patient research surveys 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. "Usual Standard of Care" Total joint arthroplasty (TJA) 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Surgical site infection rate 90 days after TJA The proportion of participants who develop a postoperative surgical site infection
Percentage change in body weight Baseline, day of TJA The percentage change in body weight lost will be calculated from baseline to TJA
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).
Prosthetic joint infection rate 90 days after TJA The proportion of participants who have a postoperative prosthetic joint infection
Total TJA operative time Day of surgery The total number of minutes will be abstracted from the operative report
Venous thromboembolism rate 90 days after TJA The proportion of participants who develop a postoperative deep venous thrombosis
Urinary tract infection rate 90 days after TJA The proportion of participants who develop a postoperative urinary tract infection
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.
Hematoma rate 90 days after TJA The proportion of participants who develop a postoperative hematoma
Cardiac event rate 90 days after TJA The proportion of participants who have a postoperative cardiac event
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
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States