Bariatric surgery group for Osteoarthritis, Knee

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Osteoarthritis, Knee+4 More
Total joint arthroplasty (TJA) - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Osteoarthritis, Knee
  • Obesity, Morbid
  • Osteoarthritis, Hip

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: 24 months

12 months
Bariatric surgery to achieve a BMI ≤ 40 kg/m2
Medical weight loss to achieve a BMI ≤ 40 kg/m2
24 months
24 month reoperation rate
24 month revision rate
24 months post TJA
Maintained a BMI ≤ 40 kg/m2 post TJA
90 days after TJA
90 day postoperative readmission rate
Cardiac event rate
Hematoma rate
Prosthetic joint infection rate
Surgical site infection rate
Urinary tract infection rate
Venous thromboembolism rate
Baseline, 24 months
Change in patient satisfaction with weight loss procedure
Baseline, day of TJA
Percentage change in body weight
Day of surgery
Total TJA operative time
Day 7
Length of hospital stay for TJA procedure

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Bariatric surgery group
1 of 2
Medical weight loss group
1 of 2
Experimental Treatment

138 Total Participants · 2 Treatment Groups

Primary Treatment: Bariatric surgery group · No Placebo Group · N/A

Bariatric surgery groupExperimental Group · 3 Interventions: Total joint arthroplasty (TJA), Bariatric surgery, Patient research surveys · Intervention Types: Procedure, Procedure, Other
Medical weight loss groupExperimental Group · 3 Interventions: Total joint arthroplasty (TJA), Medical weight loss, Patient research surveys · Intervention Types: Procedure, Behavioral, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bariatric surgery
2013
Completed Phase 4
~15470

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
357 Previous Clinical Trials
876,973 Total Patients Enrolled
David M Freccero, MDPrincipal InvestigatorBoston Medical Center

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: October 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.