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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05156762




Registration number
NCT05156762
Ethics application status
Date submitted
1/12/2021
Date registered
14/12/2021

Titles & IDs
Public title
Total Joint Arthroplasty (TJA) Weight Loss Study
Scientific 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
Secondary ID [1] 0 0
H-41295
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Hip 0 0
Osteoarthritis, Knee 0 0
Obesity, Morbid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Bariatric surgery
BEHAVIORAL - Medical weight loss
Other interventions - Patient research surveys
Treatment: Surgery - Total joint arthroplasty (TJA)
Other interventions - Usual standard of care

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.

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.

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.


Treatment: Surgery: 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 interventions: 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.

Treatment: Surgery: 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 interventions: 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.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
BEHAVIORAL
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bariatric surgery to achieve a BMI = 40 kg/m2
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Medical weight loss to achieve a BMI = 40 kg/m2
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Percentage change in body weight
Timepoint [1] 0 0
Baseline, day of TJA
Secondary outcome [2] 0 0
Total TJA operative time
Timepoint [2] 0 0
Day of surgery
Secondary outcome [3] 0 0
Length of hospital stay for TJA procedure
Timepoint [3] 0 0
Day of surgery until discharge from hospital, up to 7 days
Secondary outcome [4] 0 0
Surgical site infection rate
Timepoint [4] 0 0
90 days after TJA
Secondary outcome [5] 0 0
Venous thromboembolism rate
Timepoint [5] 0 0
90 days after TJA
Secondary outcome [6] 0 0
Hematoma rate
Timepoint [6] 0 0
90 days after TJA
Secondary outcome [7] 0 0
Urinary tract infection rate
Timepoint [7] 0 0
90 days after TJA
Secondary outcome [8] 0 0
Cardiac event rate
Timepoint [8] 0 0
90 days after TJA
Secondary outcome [9] 0 0
Prosthetic joint infection rate
Timepoint [9] 0 0
90 days after TJA
Secondary outcome [10] 0 0
90 day postoperative readmission rate
Timepoint [10] 0 0
90 days after TJA
Secondary outcome [11] 0 0
24 month revision rate
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
24 month reoperation rate
Timepoint [12] 0 0
24 months
Secondary outcome [13] 0 0
Maintained a BMI = 40 kg/m2 post TJA
Timepoint [13] 0 0
24 months post TJA
Secondary outcome [14] 0 0
Change in patient satisfaction with weight loss procedure
Timepoint [14] 0 0
Baseline, 24 months

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
138
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Other
Name
Boston Medical Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David M Freccero, MD
Address 0 0
Boston Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David M Freccero, MD
Address 0 0
Country 0 0
Phone 0 0
(617) 638-5633
Fax 0 0
Email 0 0
David.Freccero@bmc.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05156762