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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which type of knee implant is more effective for obese women with severe osteoarthritis undergoing total knee replacement (Total Knee Arthroplasty, TKA). It compares two implants: one with a stem (a rod for extra support) and one without, to assess which results in fewer complications, such as implant loosening or failure. The trial targets women already scheduled for knee replacement surgery at a specific clinic, with a BMI of 35 or higher, who are either on contraceptives or in menopause. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance knee replacement outcomes for women with similar health profiles.

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 prior data suggests that these implant types are safe for knee surgery in obese patients?

In a previous study, researchers found that patients with severe obesity who underwent total knee replacement surgery might face risks with certain types of implants. These risks include the implant becoming loose or not functioning properly, although this does not occur in every case. Another study found no major difference in early problems between different types of implants, including those with and without stems.

For implants without stems, studies have also found no major difference in complications after surgery compared to other types of implants. This suggests that both types of implants generally perform well for patients, even those with obesity. However, all surgeries carry some risks, and results can vary for each person. Participants should discuss these findings and any concerns with their doctors before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they aim to tackle obesity-related knee surgery complications with tailored implants. Traditional total knee arthroplasty (TKA) often uses standard implants that might not address specific issues faced by obese patients. This trial explores two types of tibial implants: a stemmed tibial implant and a non-stemmed version. The stemmed implant could offer better stability for larger patients, while the non-stemmed implant might reduce surgical complexity and recovery time. By comparing these two approaches, researchers hope to determine which implant type offers better outcomes for patients with obesity undergoing knee surgery.

What evidence suggests that this trial's treatments could be effective for obesity-related knee surgery complications?

This trial will compare two types of tibial implants used in total knee arthroplasty (TKA) for obese patients. Research has shown that stemmed tibial implants, which participants in Group A will receive, can reduce the risk of needing another surgery due to implant failure. The stem provides extra support, helping to keep the implant stable. However, not all studies agree, and some suggest there isn't enough proof to recommend stemmed implants for everyone. Participants in Group B will receive non-stemmed tibial implants, which appear to work just as well for patients of any weight, potentially making them suitable for both obese and non-obese patients. Overall, both options have their advantages, but the choice may depend on individual needs and the surgeon's preference. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10182724/

Total Knee Arthroplasty with Non-Stemmed Tibial ... The present study found no significant difference in the radiologic or clinical outcome of non-stemmed TKA in patients with BMIs under and over 30.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0883540325011635

Primary Total Knee Fixation Methods in Morbidly Obese ... Surgical complications included superficial wound complications, stiffness, femoral fractures, tibial subsidence, patellar tendon rupture, and ...

3. kneesurgrelatres.biomedcentral.com kneesurgrelatres.biomedcentral.com/articles/10.1186/s43019-023-00184-4

outcomes of standard keeled tibial components versus ... Patients with a normal BMI have been shown to have comparable rates of aseptic loosening with both non-stemmed and stemmed tibial components [ ...

4. thekneejournal.com thekneejournal.com/article/S0968-0160(24)00027-9/fulltext

Does the use of tibial stem extensions reduce the risk ... This study found that obese patients undergoing TKA with stemmed tibial implants may have a lower risk of aseptic revision compared with those with non-stemmed ...

5. withpower.com withpower.com/trial/phase-shock-8-2023-ba298

TKA Implant Types for Obesity-related Knee Surgery ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10088243/

Total knee arthroplasty in patients with severe obesity Patients with severe obesity [body mass index (BMI) ≥ 40 kg/m2] potentially overload the tibial component after total knee arthroplasty (TKA), ...

7. sicot-j.org sicot-j.org/articles/sicotj/full_html/2025/01/sicotj250025/sicotj250025.html

Safety and early outcomes of simultaneous bilateral TKA in ... Results: No significant difference in the occurrence of early complications between the three groups was observed. One patient was readmitted ...

8. eor.bioscientifica.com eor.bioscientifica.com/view/journals/eor/7/5/EOR-21-0090.xml

to long-term complications and outcome for morbidly obese ... Obesity correlates to osteoarthritis (OA) and is known to disproportionally increase and accelerate knee arthrosis (4, 5, 6, 7). Aging as well ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11845207/

Short-Term Outcomes of Noncemented Total Knee ... No difference was noted in postoperative complications between cemented and noncemented TKA procedures, including readmission rates within 90 ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S235234412400061X

Body Mass Index Did Not Affect the Risk of Revision 3-9 ... Results from several studies suggest that more than 30% of all patients receiving total hip replacement and TKR are obese [[7], [8], [9], [10], [11]]. A weight ...