Cemented vs Cementless Knee Implants for Osteoarthritis

Recruiting at 7 trial locations

Overseen By Kathryn Schabel, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Pregnancy, Neurologic condition, Osteoporosis, others

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

Compensation: Varies

Number of Visits: 6

Duration: During surgery

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates two types of knee implants to determine which is safer and more effective for people with osteoarthritis. The focus is on comparing cemented and cementless knee implants. Individuals with osteoarthritis considering knee replacement surgery may be suitable candidates, especially if their doctor has recommended one of these implant types. As an unphased trial, this study provides patients the opportunity to contribute to valuable research that could enhance future knee replacement options.

Will I have to stop taking my current medications?

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

What prior data suggests that these knee implant systems are safe for osteoarthritis?

Research has shown that both the cemented and cementless Persona knee implants are generally safe. Studies have found that these implants last a long time and improve patient well-being over several years. Specifically, patients with the cemented Persona knee system reported positive results up to two years post-surgery, experiencing better function and implant performance.

The cementless Persona knee system is designed to connect securely with the bone, and research has demonstrated its safety and effectiveness. Both types of implants have undergone testing in other studies and are well-tolerated by patients. No major safety concerns have been reported for either type of implant in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for knee osteoarthritis because they explore the benefits of two different implant techniques: cemented and cementless knee implants. Unlike traditional cemented implants, which use bone cement to secure the joint, the cementless option encourages natural bone growth to anchor the implant. This natural integration can potentially lead to a more stable and longer-lasting joint replacement. These innovations could offer patients more tailored options, improving overall outcomes and satisfaction.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

This trial will compare the Cemented Persona Keel Knee System with the Cementless Persona Keel Knee System for patients with osteoarthritis. Studies have shown that both cemented and cementless knee implants, such as the Persona Knee systems, are safe and effective. Specifically, research found that the cemented Persona Knee System had a 97.0% success rate at two years, indicating that the implants remained in place and functioned well for most patients. Studies also show that the cementless Persona Knee provides stable support, which can enhance knee function over time. Both types of implants generally yield good results for patients with osteoarthritis, improving knee function and reducing pain. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with various knee conditions like arthritis or deformities who need a total knee replacement. Participants must be able to follow the study's procedures and give informed consent. Pregnant individuals, those in other studies, or with mental/neurologic conditions that affect postoperative care are excluded.

Inclusion Criteria

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

I am eligible for knee replacement surgery using the Persona Knee System.

I am willing and able to follow the study's schedule for check-ups.

Exclusion Criteria

Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study would be inappropriate (e.g., prisoner; pediatric patients)

Patient is currently participating in any other surgical intervention or pain management study

Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preoperative Evaluation

Participants undergo preoperative clinical evaluations prior to their total knee arthroplasty

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either the Persona OsseoTi Keel Cementless System or the Persona Keel Cemented System during surgery

During surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up clinic visits

5 years

Visits at 3 months, 1 year, 2 years, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Cemented Persona Knee System
• Cementless Persona Knee System

Trial Overview The trial compares two types of knee replacements: one using cement (Cemented Persona Knee System) and one without (Cementless Persona Knee System). The goal is to assess their safety, performance, and clinical benefits in patients requiring surgery.

How Is the Trial Designed?

Group I: Cemented Persona Keel Knee System Active Control 1 Intervention

Persona Keel Cemented Tibia

Group II: Cementless Persona Keel Knee System Active Control 1 Intervention

Persona PPS CoCr Cementless Femur and Persona OsseoTi Keel Cementless Tibia

Cemented Persona Knee System is already approved in United States for the following indications:

Approved in United States as Persona Knee System for:

• Rheumatoid arthritis
• Osteoarthritis
• Traumatic arthritis
• Polyarthritis
• Collagen disorders
• Avascular necrosis of the femoral condyle
• Post-traumatic loss of joint configuration
• Patellofemoral erosion, dysfunction or prior patellectomy
• Moderate valgus, varus, or flexion deformities
• Salvage of previously failed surgical attempts

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

Cementless total knee replacements showed a significantly shorter time to revision (average 43 months) compared to cemented replacements (average 86 months), with over half of the cementless group needing revision within 2 years.

Despite the higher failure rate, the postoperative outcomes for revised cementless implants were comparable to those of cemented implants, indicating that revising failed cementless knees with cement is a reliable option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revision of failed cementless total knee implants with cement. Fehring, TK., Griffin, WL.[2019]

Cemented knee prostheses have a lower aseptic tibial loosening rate (2-6%) compared to cementless prostheses (up to 28%) over similar time periods, indicating that cemented options may provide better long-term stability.

Using screws to secure cementless knee endoprostheses significantly improves the stability of the tibial plateau under axial loads, suggesting that screw fixation is essential for achieving proper osseointegration and preventing loosening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The influence of bone quality and the fixation procedure on the primary stability of cementless implanted tibial plateaus]. Boos, C., Fink, K., Stomberg, P., et al.[2010]

In a study of 51 total knee arthroplasties (TKAs) with a mean follow-up of 10.4 years, a proximally cemented tibial tray with a cementless keel showed excellent clinical outcomes, with a mean Knee Society Score of 93 points.

Only one patient experienced progressive tibial radiolucencies over the follow-up period, which was successfully resolved with component revision, indicating good long-term stability and safety of this fixation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total knee arthroplasty using cementless keels and cemented tibial trays: 10-year results. Kolisek, FR., Mont, MA., Seyler, TM., et al.[2018]

In a study of 139 total knee replacements over five years, there was no significant difference in clinical outcomes such as pain, mobility, or movement between cemented and cementless implants.

Despite the higher cost of cementless fixation, the clinical results did not support its use, and while there were more radiolucent lines observed with cemented implants, the long-term significance of this finding remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised, prospective study comparing cemented and cementless total knee replacement: results of press-fit condylar total knee replacement at five years. McCaskie, AW., Deehan, DJ., Green, TP., et al.[2019]

In a study of 893 patients with 1,000 total knee prostheses followed for an average of 5.2 years, cementless implants showed slightly better subjective and functional outcomes compared to cemented implants, with Knee Society scores of 91.2 and 90.1 versus 89.6 and 83.5, respectively.

Both cementless and cemented implants demonstrated excellent safety, with a remarkable 99% implant survival rate at 5 years and no observed osteolysis around screw fixation, indicating effective long-term performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of 1,000 Performance knees: cementless versus cemented fixation. Bassett, RW.[2019]

Cemented total knee replacements (TKRs) resulted in significantly higher patient-reported outcomes, as measured by the Oxford Knee Score (OKS), compared to cementless TKRs, particularly in most age groups, indicating better functional outcomes for cemented implants.

Despite the differences in OKS scores, both cemented and cementless TKRs are considered acceptable options for patients, as the absolute differences were small and below the minimally clinically important difference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A matched comparison of the patient-reported outcome measures of cemented and cementless total knee replacements, based on the National Joint Registry of England, Wales, Northern Ireland, and Isle of Man and England's National PROM collection programme. Mohammad, HR., Judge, A., Murray, DW.[2023]

In a study of 18 matched pairs of knee prostheses with an average follow-up of five years, both cemented and uncemented fixation methods showed significant improvements in knee scores, with postoperative averages of 90 for cemented and 93 for uncemented.

Patients reported similar satisfaction levels with both types of fixation, indicating that the choice between cemented and uncemented knee prostheses may not significantly impact clinical and functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total knee arthroplasty fixation. Comparison of the early results of paired cemented versus uncemented porous coated anatomic knee prostheses. Dodd, CA., Hungerford, DS., Krackow, KA.[2014]

Cementless total knee arthroplasty designs, despite being technically more challenging, show success rates comparable to traditional cemented implants over nearly 20 years of follow-up.

The key factors for successful knee replacement are not just the type of implant used, but also the precision of the surgical technique, proper soft tissue balancing, and correct alignment, which are crucial to prevent early failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemented and cementless fixation: results and techniques. Silverton, CD.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05630053

Cemented vs Cementless Persona Keel RCT This is a prospective, multi-center, randomized controlled trial to demonstrate safety, performance, and clinical benefits of the Persona Keel CR Knee ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10744842/

Early- to Mid-Term Review of a Prospective, Multi-Center ... This study supports the excellent survivorship and patient-reported outcomes of the Persona Knee system using cemented, fixed bearing, posterior-stabilized ...

3. withpower.com withpower.com/trial/phase-arthritis-rheumatoid-11-2022-7081e

Cemented vs Cementless Knee Implants for Osteoarthritis Research shows that both cemented and cementless knee implants are generally safe, with high implant survival rates and good patient outcomes over several ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352344124002930

The Impact of Cementing Techniques on Implant Longevity ... For example, the overall implant survival was reported at 97.0% (98.2% implant-related) for the Persona Knee System at 2 years in Galea et al. [16] study. They ...

5. zimmerbiomet.com zimmerbiomet.com/content/dam/zb-corporate/en/products/specialties/knee/persona-osseo-ti-keel-tibia/3834.2-US-en-Persona-OsseoTi-Keel-Tibia-Design-Rationale_FINAL.pdf

Persona® OsseoTi Keel Tibia Design Rationale The Persona OsseoTi Keel Tibia is the latest offering within the Persona tibia continuum, representing our next iteration of cementless knee arthroplasty. This ...

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

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

7. trials.arthritis.org trials.arthritis.org/trials/NCT05787821

Persona OsseoTi Keel Compatibility Study (Total Knee ... The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total ...

8. 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 Anatomic Tibia: Helps prevent mal-rotation while facilitating proper rotation and optimal bone coverage. Mal-rotation of implants leads to over 50 percent ...