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Procedure

TJA for Osteoarthritis and Weight Loss

Boston Medical Center, Boston, MA

Targeting 3 different conditionsMedical weight loss +4 moreN/ARecruitingLed by David M Freccero, MDResearch Sponsored by Boston Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be interested in TJA as a treatment option

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up24 months

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will compare bariatric surgery, medical weight loss, and usual standard of care to optimize morbidly obese patients with end-stage osteoarthritis of the hip or knee joint for total joint arthroplasty.

Eligible Conditions

Morbid Obesity
Osteoarthritis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You must be willing to consider TJA as a treatment option.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bariatric surgery to achieve a BMI ≤ 40 kg/m2

Medical weight loss to achieve a BMI ≤ 40 kg/m2

Secondary outcome measures

24 month reoperation rate

24 month revision rate

90 day postoperative readmission rate

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Medical weight loss groupExperimental Treatment3 Interventions

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.

Group II: Bariatric surgery groupExperimental Treatment3 Interventions

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.

Group III: "Usual Standard of Care"Experimental Treatment2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Bariatric surgery

2013

Completed Phase 4

~15460

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor

379 Previous Clinical Trials

869,471 Total Patients Enrolled

16 Trials studying Obesity

67,591 Patients Enrolled for Obesity

David M Freccero, MDPrincipal InvestigatorBoston Medical Center

Media Library

Bariatric Surgery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05156762 — N/A

Obesity Research Study Groups: "Usual Standard of Care", Bariatric surgery group, Medical weight loss group

Obesity Clinical Trial 2023: Bariatric Surgery Highlights & Side Effects. Trial Name: NCT05156762 — N/A

Bariatric Surgery (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05156762 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the highest possible participant count for this experiment?

"Correct. All information available from clinicaltrials.gov indicates that this medical study is currently recruiting volunteers, having been first posted on October 3rd 2022 and recently updated on the 28th of the same month. This trial requires 138 participants to be recruited at a single location."

Answered by AI

What is the primary aim of this investigation?

"The primary aim of this year-long trial is to attain a BMI ≤ 40 kg/m2 through bariatric surgery. Secondary endpoints being evaluated include prosthetic joint infection rate, total TJA operative time, and the percentage change in body weight from baseline to postoperative results."

Answered by AI

Is there still an opportunity for people to volunteer for this experiment?

"Clinicaltrials.gov divulges that this research, which was first posted on October 3rd 2022, is actively looking for participants. The trial's particulars were last revised on the 28th of October in the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Total Joint Arthroplasty (TJA) Weight Loss Study

2022. "Total Joint Arthroplasty (TJA) Weight Loss Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05156762.

All > Morbid Obesity > Osteoarthritis Knee