Osteoarthritis, HipNCT05156762
Total Joint Arthroplasty (TJA) Weight Loss Study
A study testing Bariatric surgery, Medical weight loss and Patient research surveys in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by Boston Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Osteoarthritis, Knee, Obesity, Morbid
- What is being tested?
- Bariatric surgery, Medical weight loss and Patient research surveys
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 7 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee, Obesity, Morbid
- Being tested
- Bariatric surgery, Medical weight loss, Patient research surveys, Total joint arthroplasty (TJA), Usual standard of care
- 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
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or 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.
Medical weight lossBehavioural
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.
Patient research surveysOther
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.
Total joint arthroplasty (TJA)Procedure or surgery
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Total joint arthroplasty (TJA); Other: Usual standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (14)
Percentage change in body weight
The percentage change in body weight lost will be calculated from baseline to TJA
Measured: Baseline, day of TJA
Total TJA operative time
The total number of minutes will be abstracted from the operative report
Measured: Day of surgery
Length of hospital stay for TJA procedure
The total number of days will be abstracted from the electronic health record (EHR).
Measured: Day of surgery until discharge from hospital, up to 7 days
Surgical site infection rate
The proportion of participants who develop a postoperative surgical site infection
Measured: 90 days after TJA
Venous thromboembolism rate
The proportion of participants who develop a postoperative deep venous thrombosis
Measured: 90 days after TJA
Hematoma rate
The proportion of participants who develop a postoperative hematoma
Measured: 90 days after TJA
Urinary tract infection rate
The proportion of participants who develop a postoperative urinary tract infection
Measured: 90 days after TJA
Cardiac event rate
The proportion of participants who have a postoperative cardiac event
Measured: 90 days after TJA
Prosthetic joint infection rate
The proportion of participants who have a postoperative prosthetic joint infection
Measured: 90 days after TJA
90 day postoperative readmission rate
The rate of hospital readmission 90 days after TJA
Measured: 90 days after TJA
24 month revision rate
Need for total hip or total knee arthroplasty component revision after primary total hip or total knee arthroplasty
Measured: 24 months
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
Measured: 24 months
Maintained a BMI ≤ 40 kg/m2 post TJA
The number of participants who maintained a BMI ≤ 40 kg/m2 for 24 months
Measured: 24 months post TJA
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.
Measured: Baseline, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start3 Oct 2022
- Primary completion7 Sep 2025
- Study completion7 Sep 2025
Why it stopped: The study was halted prematurely due to a lack of resources to support the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M Freccero, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156762
- Sponsor's protocol ID
- H-41295
- Status last verified
- Oct 2025
- First submitted
- 1 Dec 2021
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05156762
- Acronym / sponsor ID
- H-41295
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted prematurely due to a lack of resources to support the study.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 7 Sep 2025 (actual)
- Study completion
- 7 Sep 2025 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery group | Experimental | Procedure: Bariatric surgery, Other: Patient research surveys, Procedure: 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 | Experimental | Behavioral: Medical weight loss, Other: Patient research surveys, Procedure: 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" | Other | Procedure: Total joint arthroplasty (TJA), Other: Usual standard of carePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryPatients 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. | Procedure or surgery | Bariatric surgery group |
| Medical weight lossStudy 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. | Behavioural | Medical weight loss group |
| Patient research surveysPatients 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. | Other | Bariatric surgery group, Medical weight loss group |
| 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. | Procedure or surgery | "Usual Standard of Care", Bariatric surgery group, Medical weight loss group |
| Usual standard of carePatients 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. | Other | "Usual Standard of Care" |
Primary outcome
Bariatric surgery to achieve a BMI ≤ 40 kg/m2
Time frame: 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
Time frame: 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.
14 secondary outcomes
Percentage change in body weight
Time frame: Baseline, day of TJA
Total TJA operative time
Time frame: Day of surgery
Length of hospital stay for TJA procedure
Time frame: Day of surgery until discharge from hospital, up to 7 days
Surgical site infection rate
Time frame: 90 days after TJA
Venous thromboembolism rate
Time frame: 90 days after TJA
Hematoma rate
Time frame: 90 days after TJA
Urinary tract infection rate
Time frame: 90 days after TJA
Cardiac event rate
Time frame: 90 days after TJA
Prosthetic joint infection rate
Time frame: 90 days after TJA
90 day postoperative readmission rate
Time frame: 90 days after TJA
24 month revision rate
Time frame: 24 months
24 month reoperation rate
Time frame: 24 months
Maintained a BMI ≤ 40 kg/m2 post TJA
Time frame: 24 months post TJA
Change in patient satisfaction with weight loss procedure
Time frame: Baseline, 24 months
Results and safety
The study was stopped early (reason given: The study was halted prematurely due to a lack of resources to support the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Freccero, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery, Medical weight loss and Patient research surveys in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was halted prematurely due to a lack of resources to support the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bariatric surgery to achieve a BMI ≤ 40 kg/m2 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.