Knee Replacement for Osteoarthritis

Not currently recruiting at 13 trial locations

Overseen By Kacy Arnold, RN, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Infection, Osteoporosis, Neuromuscular disease, others

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

Compensation: Varies

Number of Visits: 7

Duration: Surgery day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a knee implant for individuals with severe knee pain from conditions like osteoarthritis. Researchers aim to assess the implant's longevity and performance in daily life. The treatment under evaluation is the Zimmer Persona Total Knee System. Suitable candidates have experienced severe knee pain or disability from conditions like arthritis and have not undergone a full or partial knee replacement on the same knee.

As an unphased trial, this study provides an opportunity to contribute to important research that could enhance knee implant options for future patients.

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 coordinators or your doctor.

What prior data suggests that the Zimmer Persona Total Knee System is safe for knee replacement?

Research has shown that the Zimmer Persona Total Knee System is safe and effective. Studies have found good results up to two years after surgery, with patients experiencing positive outcomes without major problems. The implant is generally well-accepted, with no serious safety issues reported. This knee system is designed to fit each patient better, potentially improving comfort and movement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Zimmer Persona Total Knee System is unique because it offers a highly personalized approach to knee replacement for osteoarthritis. Unlike standard knee replacements that come in a limited range of sizes, this system is designed to match the unique anatomy of each patient's knee, potentially improving comfort and joint function. Researchers are excited about this treatment because it aims to enhance the fit and feel of the implant, leading to better outcomes and quicker recovery times for patients.

What evidence suggests that the Zimmer Persona Total Knee System is effective for knee replacement in osteoarthritis?

Research shows that the Zimmer Persona Total Knee System, which participants in this trial will receive, performs well in knee replacement surgeries. Studies have found that patients experience good results, with implants lasting up to two years after surgery. The system is designed to enhance knee stability and movement. Patients report that their knees function well and feel comfortable. Overall, evidence supports the Zimmer Persona Total Knee System as a dependable choice for individuals needing knee replacements due to osteoarthritis. ^{1 2 4 6 7}

Who Is on the Research Team?

Kacy Arnold, RN, MBA

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with severe knee pain and disability due to conditions like osteoarthritis or rheumatoid arthritis, among others. Candidates must need a total knee replacement, be able to consent, and commit to follow-up evaluations. Exclusions include those in other studies, with certain bone/muscle diseases, previous knee replacements on the same side, or infections affecting the joint.

Inclusion Criteria

I am eligible for a knee replacement based on my doctor's assessment.

Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form

I am eligible for a specific knee replacement surgery outside of this study.

Exclusion Criteria

I have osteoporosis or a condition affecting my muscles or nerves that impacts my limb.

My joint is very unstable because of damaged ligaments.

I have had knee replacement surgery on the same side before.

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 fixed bearing knee implants during total knee arthroplasty

Surgery day

1 visit (in-person)

Post-operative Evaluation

Post-operative clinical and radiographic evaluations conducted at specified intervals

10 years

Visits at 6 weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Zimmer Persona Total Knee System

Trial Overview The study aims to collect data on the performance of Persona fixed bearing knee implants used in total knee arthroplasty (knee replacement surgery). It will focus on how long the implant lasts (implant survivorship) and how well it works clinically for patients who receive it.

How Is the Trial Designed?

Group I: PERSONA TKA Experimental Treatment 1 Intervention

Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System

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

Published Research Related to This Trial

The study compared the amount of bone removed during femoral box osteotomy for three total knee arthroplasty designs and found that the Persona design consistently required less bone resection than the Vanguard and Sigma PS designs across all implant sizes.

This suggests that when choosing a posterior stabilized knee implant, selecting the Persona model may be beneficial as it preserves more distal femoral bone, although the clinical implications of this finding need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of differences in bone removal during femoral box osteotomy for primary total knee arthroplasty. Graceffa, A., Indelli, PF., Basnett, K., et al.[2020]

The Zimmer iASSIST system, an accelerometer-based navigation device for total knee arthroplasty (TKA), was found to be safe and effective in restoring the mechanical axis of the knee, based on a study of 60 patients with primary osteoarthritis.

However, the study revealed no significant differences in lower limb alignment or component placement between surgeries performed with the iASSIST system and those using conventional methods, indicating that both techniques yield similar outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Similar radiological results with accelerometer-based navigation versus conventional technique in total knee arthroplasty. Moo, IH., Chen, JYQ., Chau, DHH., et al.[2019]

In a study of 2033 total knee arthroplasty patients, the annual rate of adverse events decreased from 9.2% in 2002 to 5.8% in 2004, indicating improved safety over time.

Patients with congestive heart failure and chronic obstructive pulmonary disease had a significantly higher risk of adverse events during hospitalization, and experiencing an adverse event was linked to increased length of hospital stay and higher 30-day postprocedure mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after total knee arthroplasty: a national Medicare study. Huddleston, JI., Maloney, WJ., Wang, Y., et al.[2009]

The Persona Knee implant system demonstrated high safety and efficacy in total knee arthroplasty, with a 2-year survival rate of 99% and only one revision due to infection among 146 surgeries performed.

Patient-reported outcomes significantly improved post-surgery, with the Oxford Knee Score increasing from an average of 22.1 to 41.8, indicating enhanced pain relief, function, and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. Mathijssen, NMC., Verburg, H., London, NJ., et al.[2020]

The German biologics register RABBIT and European data show that TNF inhibitors do not increase the overall risk of cancer and are associated with a lower frequency of venous thromboembolism compared to conventional DMARDs.

Tocilizumab, an interleukin-6 inhibitor, is linked to a higher incidence of lower intestinal tract perforations, while Janus kinase inhibitors raise the risk of herpes zoster, highlighting the need for careful monitoring of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Risk profile of disease-modifying antirheumatic drugs: an update from the RABBIT register]. Albrecht, K., Strangfeld, A.[2021]

In a study of 91 knees from 85 patients who received the Persona® implant for total knee arthroplasty, the implant showed a low revision rate of 2.19% and good clinical outcomes after an average follow-up of 5.9 years.

Patients reported high functional scores, with a mean Oxford Knee Score of 44.21 and a mean range of motion of 120.8º, indicating effective pain relief and improved mobility post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm results of a new personalized knee implant for total knee arthroplasty: implant survivorship and patient-reported outcome after five years' follow-up. Dauder Gallego, C., Moreno Fenoll, IB., Patiño Contreras, JL., et al.[2022]

Patient-specific instrumentation (PSI) technology for knee replacement surgery allows for more precise planning and execution, leading to reduced surgical tray usage and improved predictability of component sizes, as demonstrated in a study of 88 patients.

The use of PSI resulted in more accurate alignment of knee components during surgery, although some intraoperative adjustments were still necessary, indicating that while PSI is promising, further development is needed for optimal soft tissue balancing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Total and unicompartmental knee replacement. Patient-specific Instrumentation]. Köster, G., Biró, C.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02255383

Persona Total Knee Arthroplasty Outcomes Study The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6399845/

Patient reported outcomes and implant survivorship after ... The Persona Knee implant is safe and effective and the clinical results up to two years after surgery are promising.

3. zimmerbiomet.com zimmerbiomet.com/content/dam/zb-corporate/en/products/specialties/knee/persona-the-personalized-knee/1211.3-GLBL-en%20Persona%20Primary%20Clinical%20Summary.pdf

Persona ® The Personalized Knee ® Clinical Summary Gait Parameters and. Functional Outcomes After Total Knee Arthroplasty Using Persona Knee System with Cruciate Retaining and. Ultracongruent Knee Inserts.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03568123

A Comparison of the Persona Total Knee Arthroplasty ... In this project the investigators wish to: Evaluate stability and fixation, intra-operative and postop complications, survivorship and patient reported outcome ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11862213/

Patient-reported outcomes and complications of a new ... Patient reported outcomes and implant survivorship after total knee arthroplasty with the persona knee implant system: two year follow up.

6. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-knee-system.html

Persona® The Personalized Knee Our most comprehensive knee system, including anatomically accurate components with finer increments to help surgeons personalize the fit for each patient.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02337244

Zimmer POLAR Persona - TKA (EMEA Study) The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in ...