TKA Implant Types for Obesity-related Knee Surgery Complications

Overseen By Jacob Elkins, MD, PHD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jacob M. Elkins

Disqualifiers: Infection, Previous knee surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Surgery and immediate postoperative care

54 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Non-stemmed tibial implant, Stemmed Tibial Implant, Total Knee Arthroplasty (TKA) for obesity-related knee surgery complications?

Research shows that while obesity can lead to more complications after total knee arthroplasty (TKA), the procedure can still significantly improve knee function and support weight loss. However, obese patients may face a higher risk of mechanical issues, like tibial component loosening, which suggests careful management and implant selection are crucial for better outcomes. ^{1 2 3 4 5}

Is total knee arthroplasty (TKA) safe for people with obesity?

TKA in people with obesity can lead to higher risks of complications like tibial loosening, wound issues, and mechanical failures, especially in those with a BMI over 35. Careful management and consideration of these risks are important to improve safety and outcomes. ^{1 2 3 6 7}

How does Total Knee Arthroplasty (TKA) differ from other treatments for obesity-related knee surgery complications?

Total Knee Arthroplasty (TKA) is a surgical procedure that replaces the knee joint with an artificial implant, which is particularly challenging in obese patients due to increased risks of mechanical complications like tibial loosening and wound issues. Unlike other treatments that may focus on weight management or non-surgical interventions, TKA directly addresses joint damage but requires careful consideration of implant alignment and fixation in obese individuals. ^{1 2 3 6 8}

What is the purpose of this trial?

The purpose of this study is to compare rates of varus collapse, aseptic loosening, and implant failure in female obese patients undergoing total knee arthroplasty (TKA) and will review the degree of influence of stemmed tibial components versus non-stemmed tibial components on varus collapse and aseptic loosening, a consequence of implant micromotion.

Eligibility Criteria

This trial is for female adult patients with severe osteoarthritis who are obese (BMI of 35 kg/m2 or above) and scheduled for total knee arthroplasty at the PI's clinic. It includes women using contraceptives or in menopause. Excluded are those with infections, high-risk medical conditions, previous knee surgery on the same site, or pregnant/capable of pregnancy.

Inclusion Criteria

I am a woman using contraceptives or I am in menopause.

I am a woman with severe knee arthritis scheduled for knee replacement surgery.

Only patients from the PI's clinic will be included

Exclusion Criteria

I have not had knee surgery at the site of my current arthroplasty.

I currently have an infection or inflammatory condition.

I am pregnant or able to become pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty with either stemmed or non-stemmed tibial components

Surgery and immediate postoperative care

1 visit (in-person)

Follow-up

Participants are monitored for varus collapse, aseptic loosening, and implant failure with routine surgical care and radiographs

5 years

Visits at 6 weeks, 12 weeks, 1 year, 2 years, 3 years, and 5 years (in-person)

Treatment Details

Interventions

• Non-stemmed tibial implant
• Stemmed Tibial Implant
• Total Knee Arthroplasty (TKA)

Trial Overview The study aims to compare how well two types of tibial components - stemmed and non-stemmed - work in preventing varus collapse and aseptic loosening after total knee arthroplasty in obese female patients. The focus is on implant stability over time.

Participant Groups

Group I: Group A: Stemmed Tibial Implant Active Control 2 Interventions

This study group will receive a stemmed tibial implant as part of their TKA.

Group II: Group B: Non-Stemmed Tibial implant Active Control 2 Interventions

This study group will receive a non-stemmed tibial implant as part of their TKA.

Who Is Running the Clinical Trial?

Jacob M. Elkins

Lead Sponsor

Trials

2

Recruited

70+

References

1. United States pubmed.ncbi.nlm.nih.gov

Morbid Obesity and Total Knee Arthroplasty: A Growing Problem. [2022]

2. China pubmed.ncbi.nlm.nih.gov

The effect of obesity on mechanical failure after total knee arthroplasty. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Review article: Outcome of total knee arthroplasty in obese patients. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

The Utility of Increased Constraint in Primary Total Knee Arthroplasty for Obese Patients. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Evolution of body mass index and complications rate in severely or morbidly obese patients undergoing total knee arthroplasty. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Bariatric Surgery on Risk of Complications After Total Knee Arthroplasty: A Randomized Clinical Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Tibial Bone Quality in Former Bariatric Surgery Patients with Osteoarthritis. [2022]

8. France pubmed.ncbi.nlm.nih.gov

Early complications of revision total knee arthroplasty in morbidly obese patients. [2020]