Total Knee Arthroplasty for Osteoarthritis

Recruiting at 15 trial locations

Overseen By Erik Kowalski, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Pregnancy, Neurological condition, Osteoporosis, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Surgery day

760 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a specific knee implant for individuals undergoing total knee arthroplasty (also known as total knee replacement surgery). It tests various methods of attaching the implant, either with or without cement. Those considering knee replacement surgery due to issues like arthritis or previous surgical failures might be suitable candidates. Participants will aid researchers in understanding the benefits and performance of these implants in real-world scenarios. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to the validation of a potentially groundbreaking treatment.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that the Persona implant and its instrumentation are safe for primary total knee arthroplasty?

Studies have shown that both cementless and cemented total knee replacements are similarly safe. Research indicates that cementless knee replacements provide strong, long-lasting results, with patients reporting outcomes similar to those with cemented replacements. However, recovery may be slower with cementless options. In contrast, cemented knee replacements carry a slightly higher risk of bone loss around the implant.

Short-term studies reveal that a combination of cementless parts in the knee is as safe and functional as cemented ones. Overall, both types of knee replacements are generally well-tolerated, with differences mainly in recovery time and specific risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Persona OsseoTi Keel compatibility study because it explores innovative approaches to total knee arthroplasty (TKA) that could enhance patient outcomes. Unlike traditional knee replacements that often rely on cemented components for stability, this study investigates the use of cementless technology, which allows the bone to grow directly onto the implant, potentially leading to a more natural integration and longer-lasting joint. This method could reduce complications associated with cement, such as loosening over time, and promote quicker recovery. By examining different configurations of cementless and cemented options for the femur, tibia, and patella, researchers aim to pinpoint the most effective combination for improving the longevity and function of knee replacements.

What evidence suggests that this trial's treatments could be effective for total knee arthroplasty?

This trial will compare different methods of total knee replacement, including cemented and cementless approaches. Research has shown that both methods are highly effective. Cementless knee replacements, which allow bone to grow into the implant, have demonstrated long-term success and often result in quicker surgeries. Cemented knee replacements have been the standard for many years, with proven long-term success. While debate continues about which method is superior, both are effective. Some studies suggest that cementless implants might lead to a slower recovery in the initial months after surgery, but the long-term outcomes remain positive. ^{2 6 7 8 9}

Who Is on the Research Team?

Hillary Overholser

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient is of legal age and skeletally mature

Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) / Ethics Committee (EC) approved Informed Consent document

Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Participants undergo preoperative clinical evaluations prior to their total knee arthroplasty

1-2 weeks

Treatment

Participants receive the Persona Total Knee System during total knee arthroplasty

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for safety, performance, and clinical benefits of the Persona implant

5 years

Visits at 3 months, 1, 2, 5, 7, and 10 years post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Total Knee Arthroplasty

How Is the Trial Designed?

Group I: Cohort 9 Experimental Treatment 1 Intervention

Cementless Femur Cementless Tibia

Group II: Cohort 8 Experimental Treatment 1 Intervention

Cementless Femur Cemented Tibia

Group III: Cohort 7 Experimental Treatment 1 Intervention

Cementless Femur Cemented Tibia

Group IV: Cohort 6 Experimental Treatment 1 Intervention

Cementless Femur Cemented Tibia

Group V: Cohort 5 Experimental Treatment 1 Intervention

Cementless Femur Cemented Tibia

Group VI: Cohort 4 Experimental Treatment 1 Intervention

Cemented Femur Cemented Tibia

Group VII: Cohort 3 Experimental Treatment 1 Intervention

Cemented Femur Cemented Tibia

Group VIII: Cohort 2 Experimental Treatment 1 Intervention

Cementless Femur Cementless Tibia

Group IX: Cohort 12 Experimental Treatment 1 Intervention

Cementless Femur Cementless Tibia Cementless Patella

Group X: Cohort 11 Experimental Treatment 1 Intervention

Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10.

Group XI: Cohort 10 Experimental Treatment 1 Intervention

Cementless Femur Cementless Tibia

Group XII: Cohort 1 Experimental Treatment 1 Intervention

Cementless Femur Cementless Tibia

Total Knee Arthroplasty is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Total Knee Arthroplasty for:

• Severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle

Approved in United States as Total Knee Replacement for:

• Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle

Approved in Canada as Total Knee Arthroplasty for:

• Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle

Approved in Japan as Total Knee Replacement for:

• Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle

Approved in China as Total Knee Arthroplasty for:

• Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle

Approved in Switzerland as Total Knee Replacement for:

• Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9693456/

The Evolution, Current Indications and Outcomes of ...

Overall, cemented and cementless TKA have great results in modern times and there is still a debate as to which implant is superior. Keywords: ...

2.

sicot-j.org

sicot-j.org/articles/sicotj/full_html/2020/01/sicotj200052/sicotj200052.html

Survival rate of cemented versus cementless tibial ...

The purpose of this study was to compare the survivorship of cemented versus cementless tibial baseplate in primary total knee arthroplasty.

3.

josr-online.biomedcentral.com

josr-online.biomedcentral.com/articles/10.1186/s13018-024-04966-8

Fixation options for total knee arthroplasty: a comprehensive ...

Cemented fixation has long been regarded as the gold standard for TKA, boasting high survival rates over long-term follow-ups [6,7,8]. Non- ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352344124000451

Cemented vs Cementless Robotic-Assisted Total Knee ...

Our retrospective study demonstrated higher return to operating room in the cemented group vs the cementless group.

5.

journalmsr.com

journalmsr.com/cemented-versus-uncemented-tibial-components-in-primary-total-knee-arthroplasty-a-systematic-review-and-meta-analysis-of-long-term-outcomes/

Cemented versus uncemented tibial components in ...

Uncemented tibial fixation showed comparable outcomes to the cemented tibial fixation in TKA with significantly greater initial MTPM.

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0883540325004693

To Cement or Not? Ten-Year Results of a Prospective ...

Cementless and cemented TKA had equivalent patient-reported outcomes and survivorship at 10-year follow-up. Cemented fixation had a higher rate of osteolysis ...

7.

arthroplastyjournal.org

arthroplastyjournal.org/article/S0883-5403(24)00198-0/fulltext

Cementless Total Knee Arthroplasty: A Resurgence—Who, ...

Cementless TKA provides durable biologic fixation and successful long-term results with improved operating room efficiency.

8.

arthroplastytoday.org

arthroplastytoday.org/article/S2352-3441(25)00179-7/fulltext

Cementless Tibial Fixation Results in Slower Recovery but ...

∙ McAsey, C.J.. To cement or not? Two-year results of a prospective, randomized study comparing cemented vs. Cementless total knee arthroplasty ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11141522/

Survivorship and complications of cementless compared to ...

The meta-analysis revealed the advantage of cementless fixation over cemented fixation in implant survivorship, with 0.6% and 2.6% of aseptic loosening in each ...