Knee Replacement for Osteoarthritis

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

737 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance.

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 data supports the effectiveness of the treatment Zimmer Persona Total Knee System for knee replacement in osteoarthritis?

Research shows that the Zimmer Persona Total Knee System, a personalized knee implant, has promising outcomes. Studies report good patient satisfaction and implant durability up to five years after surgery, indicating its effectiveness for knee replacement. ^{1 2 3 4 5}

Is knee replacement surgery generally safe for humans?

Knee replacement surgery, including systems like the Zimmer Persona Total Knee System, has been studied for safety, with adverse events reported in a small percentage of cases. A national study found that adverse events occurred in 5.8% to 9.2% of patients over several years, indicating that while generally safe, there are some risks involved. ^{6 7 8 9 10}

How is the Zimmer Persona Total Knee System treatment different from other treatments for knee osteoarthritis?

The Zimmer Persona Total Knee System is unique because it offers a personalized implant design that aims to improve the fit and function of the knee replacement, potentially leading to better outcomes and higher flexibility compared to standard knee implants. ^{1 3 4 5 11}

Research Team

Kacy Arnold, RN, MBA

Principal Investigator

Zimmer Biomet

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. France 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. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Profile of osteoarthritic patients undergoing hip or knee arthroplasty, a step toward a definition of the "need for surgery". [2022]

3. England 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. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Promising early outcomes of a novel anatomic knee system. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

[Total and unicompartmental knee replacement. Patient-specific Instrumentation]. [2018]

6. Brazil pubmed.ncbi.nlm.nih.gov

Epidemiology of total hip and knee replacement: a cross-sectional study. [2022]

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

Adverse events after total knee arthroplasty: a national Medicare study. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Similar radiological results with accelerometer-based navigation versus conventional technique in total knee arthroplasty. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Risk profile of disease-modifying antirheumatic drugs: an update from the RABBIT register]. [2021]

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

NIH Consensus Statement on total knee replacement. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Analysis of differences in bone removal during femoral box osteotomy for primary total knee arthroplasty. [2020]