Cementless Knee Replacement for Osteoarthritis

Recruiting at 19 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DePuy Orthopaedics

Must not be taking: Muscular disorder medications

Disqualifiers: Pregnancy, Inflammatory arthritis, Neurological disorders, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

540 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking prescription medications for a muscular disorder that limits mobility, you may not be eligible to participate.

Is cementless knee replacement generally safe for humans?

Cementless knee replacements have been studied for safety, showing some complications like higher revision rates compared to cemented ones, but also demonstrating good long-term outcomes in certain designs. Some studies found no significant increase in complications compared to cemented options, suggesting they can be safe for treating knee osteoarthritis. ^{1 2 3 4 5}

How does cementless total knee arthroplasty differ from other treatments for osteoarthritis?

Cementless total knee arthroplasty is unique because it avoids using cement to fix the knee implant, aiming for a natural bond between the bone and implant. This method is particularly appealing for younger patients with good bone quality, as it preserves bone stock and reduces the risk of cement-related issues, although it may have a higher revision rate compared to cemented options. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Cementless Total Knee Arthroplasty for osteoarthritis?

Research shows that cementless knee replacements, like the Miller-Galante type, improve pain, movement, and walking ability significantly over 2 to 5 years, with no signs of loosening in the uncemented components. Additionally, a study found similar long-term survival rates for cementless and cemented knee replacements, suggesting that cementless options can be effective. ^{1 4 9 10 11}

Who Is on the Research Team?

Sukhjeet Kaur

Principal Investigator

Sponsor GmbH

Are You a Good Fit for This Trial?

This trial is for men and women aged 22-80 who are not bedridden, can consent to the study, understand procedures, complete questionnaires in English or translations provided, diagnosed with non-inflammatory degenerative joint disease (NIDJD), and suitable for cementless knee replacement. Exclusions include recent participation in other trials, litigation involvement, inflammatory arthritis conditions, life expectancy under five years, pregnancy/lactation status among others.

Inclusion Criteria

Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in either English or one of the available translations

I have been diagnosed with a non-inflammatory joint disease.

I am between 22 and 80 years old.

Exclusion Criteria

I have pain from my spine that spreads to the limb getting knee replacement.

I am currently pregnant or breastfeeding.

Contralateral knee has already been enrolled in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty and initial recovery

6 weeks

1 visit (in-person)

Post-operative Assessment

Participants are assessed for post-operative outcomes using various patient-reported measures and radiographic evaluations

2 years

Multiple visits (in-person and virtual) at 6 weeks, 6 months, 1 year, and 2 years

Long-term Follow-up

Participants are monitored for long-term outcomes, including survivorship and adverse events

5 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cementless Total Knee Arthroplasty

Trial Overview The ATTUNE Cementless Total Knee Arthroplasty (TKA) system's performance is being tested. Specifically looking at functional improvements two years after surgery using the KOOS questionnaire. It compares cruciate retaining rotating platform and posterior stabilized rotating platform configurations of the TKA system.

How Is the Trial Designed?

Group I: ATTUNE Cementless RP TKA Experimental Treatment 1 Intervention

Subjects will receive a cementless, rotating platform total knee arthroplasty

Cementless Total Knee Arthroplasty is already approved in United States, European Union for the following indications:

Approved in United States as Cementless Total Knee Arthroplasty for:

• Severe knee damage due to arthritis or injury
• Significant knee pain
• Younger patients with good bone quality

Approved in European Union as Cementless Total Knee Arthroplasty for:

• Severe knee damage due to arthritis or injury
• Significant knee pain
• Younger patients with good bone quality

Who Is Running the Clinical Trial?

DePuy Orthopaedics

Lead Sponsor

Trials

81

Recruited

26,000+

Massimo Calafiore

DePuy Orthopaedics

Chief Executive Officer since 2023

MBA from Harvard Business School

Dr. Michael Stein

DePuy Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan

Published Research Related to This Trial

Uncemented total knee arthroplasty (TKA) has a significantly higher risk of implant failure due to aseptic loosening compared to cemented TKA, with odds ratios of 3.41 and 4.73 at 5 and 10 years, respectively, based on a meta-analysis of nine studies.

There is no significant difference in infection rates between uncemented and cemented TKAs, indicating that the fixation method does not influence the likelihood of infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Similar survival between uncemented and cemented fixation prostheses in total knee arthroplasty: a meta-analysis and systematic comparative analysis using registers. Wang, H., Lou, H., Zhang, H., et al.[2021]

In a study comparing cemented and uncemented fixation methods in total knee replacement involving 12-14 cases per group, cemented fixation showed significantly less component migration over 2 years compared to press-fit uncemented fixation.

While clinical outcomes at 2 years were similar, the uncemented groups reported more pain, indicating that cemented fixation may provide better stability and comfort in the Kinemax design of tibial components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison between cemented, press-fit, and HA-coated interfaces in Kinemax total knee replacement. Walker, PS., Sathasivam, S., Cobb, A., et al.[2019]

Citations

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Navigated cementless total knee arthroplasty - medium-term clinical and radiological results. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A randomised, controlled trial of cemented versus cementless press-fit condylar total knee replacement. Ten-year survival analysis. [2019]

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

Cement versus cementless fixation in total knee arthroplasty. [2019]

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

[2- to 5-year follow-up of cementless implantable knee joint prosthesis of the Miller-Galante type]. [2006]

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

Similar survival between uncemented and cemented fixation prostheses in total knee arthroplasty: a meta-analysis and systematic comparative analysis using registers. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Uncemented tantalum metal components versus cemented tibial components in total knee arthroplasty: 11- to 15-year outcomes of a single-blinded randomized controlled trial. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A comparison between cemented, press-fit, and HA-coated interfaces in Kinemax total knee replacement. [2019]

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

Cementless fixation in Oxford unicompartmental knee replacement: a multicentre study of 1000 knees. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Cementless knee arthroplasty. [2020]

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

Cementless total knee replacement in patients 50 years old and under. [2016]

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

[Comparison of medium-term clinical and radiological outcome between cemented and cementless medial unicompartmental knee arthroplasty]. [2016]