Total Joint Arthroplasty (TJA) Weight Loss Study

NCT05156762 | Terminated

• 1 other identifier: H-41295
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee; Obesity, Morbid

Keywords

Bariatric surgery; Medical weight loss; Total Hip Arthroplasty (THA); Total Knee Arthroplasty (TKA); Total Joint Arthroplasty (TJA); Body Mass Index >40 kg/m2; Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Percentage change in body weight

  Baseline, day of TJA

• Total TJA operative time

  Day of surgery

• Length of hospital stay for TJA procedure

  Day of surgery until discharge from hospital, up to 7 days

• Surgical site infection rate

  90 days after TJA

• Venous thromboembolism rate

  90 days after TJA

Study Arms (3)

Bariatric surgery group

EXPERIMENTAL

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; Other: Patient research surveys; Procedure: Total joint arthroplasty (TJA)

Medical weight loss group

EXPERIMENTAL

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; Other: Patient research surveys; Procedure: Total joint arthroplasty (TJA)

"Usual Standard of Care"

OTHER

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); Other: Usual standard of care

Interventions

Bariatric surgery PROCEDURE

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.

Bariatric surgery group

Medical weight loss BEHAVIORAL

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.

Medical weight loss group

Patient research surveys OTHER

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.

Bariatric surgery group; Medical weight loss group

Total joint arthroplasty (TJA) PROCEDURE

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.

"Usual Standard of Care"; Bariatric surgery group; Medical weight loss group

Usual standard of care OTHER

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.

"Usual Standard of Care"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee; Obesity, Morbid

Interventions

Bariatric Surgery; Arthroplasty, Replacement

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• David M Freccero, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: October 3, 2022
• Primary Completion: September 7, 2025
• Study Completion: September 7, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)