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NCT05156762 · ClinicalTrials.gov registry record · NA
Total Joint Arthroplasty (TJA) Weight Loss Study
A NA study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT05156762 is a NA study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 3 participants.
The verdict
NCT05156762, a NA study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
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.
Interventions
- PROCEDURE Bariatric surgery
- OTHER Usual standard of care
- BEHAVIORAL Medical weight loss
- OTHER Patient research surveys
- PROCEDURE Total joint arthroplasty (TJA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2025-09-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05156762
The ClinicalTrials.gov registry entry for NCT05156762 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Bariatric surgery is the first listed.
NCT05156762 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05156762 about?
NCT05156762 is a clinical study titled "Total Joint Arthroplasty (TJA) Weight Loss Study". 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 inc...
What is the current status of trial NCT05156762?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2022-10-03. Estimated completion is 2025-09-07.
What interventions are being tested in trial NCT05156762?
The interventions under investigation include: Bariatric surgery (PROCEDURE), Usual standard of care (OTHER), Medical weight loss (BEHAVIORAL), Patient research surveys (OTHER), Total joint arthroplasty (TJA) (PROCEDURE).
Who is sponsoring clinical trial NCT05156762?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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