Total Joint Arthroplasty (TJA) Weight Loss Study

NATerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

October 3, 2022

Primary Completion Date

September 7, 2025

Study Completion Date

September 7, 2025

Conditions
Osteoarthritis, HipOsteoarthritis, KneeObesity, Morbid
Interventions
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."

Trial Locations (1)

02118

Boston Medical Center, Boston

Sponsors
All Listed Sponsors
lead

Boston Medical Center

OTHER

NCT05156762 - Total Joint Arthroplasty (TJA) Weight Loss Study | Biotech Hunter | Biotech Hunter