Cemented vs. Cementless Partial Knee Replacement for Knee Arthroplasty

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Anderson Orthopaedic Research Institute

Disqualifiers: Non-English speakers, Smokers, Porotic bone, Others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of partial knee replacement surgeries: one uses cement to secure the new knee parts, while the other uses a special 3-D printed metal that requires no cement (cementless fixation). The researchers aim to determine if patient outcomes differ between the two methods after at least two years. Individuals with knee issues who need a partial knee replacement and have suitable knee bone for either surgery type may qualify for this trial. As an unphased trial, it offers a unique opportunity to contribute to advancements in knee replacement techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this knee replacement method is safe?

Research has shown that cementless knee replacements are safe and generally well-received by patients. One study found low failure rates for these replacements over at least 4.2 years of follow-up. Another study discovered that people with low bone density could safely undergo cementless knee surgery, achieving results similar to those with normal bone density. Additionally, a review of several studies reported high success rates for cementless knee replacements over 5, 10, and even up to 15 years, with very few cases of issues like the implant becoming loose without infection.

In some instances, reports noted the implant settling into the bone, but this often occurred without causing symptoms. Overall, cementless knee replacements appear to be a dependable option with a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about cementless fixation for partial knee replacement because it offers a unique approach compared to the traditional cemented method. Unlike cemented fixation, which relies on bone cement to secure the implant, cementless fixation encourages natural bone growth to integrate with the implant. This can potentially lead to a longer-lasting bond and reduce the risk of complications associated with cement use. The promise of improved durability and reduced postoperative issues makes this treatment an exciting prospect for enhancing knee arthroplasty outcomes.

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

This trial will compare cemented and cementless partial knee replacements for knee arthroplasty. Research has shown that cementless partial knee replacements, one of the options in this trial, can perform well, with good results and few complications over time. Cementless fixation might reduce the need for additional surgery and extend the implant's lifespan. It allows the implant to naturally bond with the bone, potentially increasing durability. Studies have found that both cemented and cementless methods, both tested in this trial, can similarly improve pain and physical function in the first year after surgery. Overall, cementless options are considered a strong alternative to cemented ones for partial knee replacements. ^{1 6 7 8 9}

Who Is on the Research Team?

Robert Hopper

Principal Investigator

Anderson Orthopaedic Research Institute

Are You a Good Fit for This Trial?

This trial is for people aged 18-85 who need a medial fixed bearing partial knee replacement and are suitable for both cemented and cementless fixation. It excludes non-English speakers, those with very weak bones, prior high tibial osteotomy with hardware, unsuitable bone quality or cuts during surgery, smokers, or if they need total knee arthroplasty due to advanced arthritis.

Inclusion Criteria

My bones are suitable for surgery with or without bone cement.

I have had a partial knee replacement with a fixed bearing.

Exclusion Criteria

Grossly porotic bone

Current smokers

Non-English speakers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either cemented or cementless partial knee replacement surgery

1 week

1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Regular visits as per clinical protocol

Long-term follow-up

Participants continue to be monitored for long-term outcomes

3 additional years

What Are the Treatments Tested in This Trial?

Interventions

• Cementless fixation

Trial Overview The study compares two types of partial knee replacements: one using a new modular 3-D printed porous metal that doesn't use cement (cementless), and the other using traditional methods where the components are secured with cement (cemented). The goal is to see if there's any difference in clinical outcomes after at least two years.

How Is the Trial Designed?

Group I: Cementless Experimental Treatment 1 Intervention

Cementless fixation partial knee replacement

Group II: Cemented Active Control 1 Intervention

Cemented fixation partial knee replacement

Who Is Running the Clinical Trial?

Anderson Orthopaedic Research Institute

Lead Sponsor

Trials

14

Recruited

1,600+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12056710/

Cementless unicompartmental knee arthroplasty is safe ... Cementless UKA is a viable alternative to cemented UKAs with a low failure rate, without a lower clinical benefit at a minimum follow‐up of 4.2 years.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9966646/

Clinical and Functional Results of Cementless ... Cementless OUKR shows excellent clinical outcome and high survival rates after five years. The tibial plateau fracture in cementless UKR represents a serious ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2059775424001871

Cemented versus cementless unicompartmental knee ... Studies have shown that cementless fixation also may reduce the prevalence of radiolucent lines (RLL), improve implant survivorship, and lower revision rates ...

4. link.springer.com link.springer.com/article/10.1007/s00402-024-05670-2

Cementless fixation in total knee arthroplasty Cementless fixation in TKA shows a theoretical advantage of a biological fixation, being potentially longer-lasting and initially preserves the native bone ...

5. boneandjoint.org.uk boneandjoint.org.uk/Article/10.1302/2633-1462.55.BJO-2024-0007.R1

Knee - The Bone & Joint Journal Cementless and cemented medial UKA led to comparable improvement in physical function and pain reduction during the initial postoperative year.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05616884

Cemented vs. Cementless Unicompartmental Knee ... Also called a data safety and monitoring ... knee replacements using cementless and cemented fixation will demonstrate no differences in clinical outcome.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6995049/

The clinical outcomes of cementless unicompartmental knee ... We found that patients with reduced BMD could safely undergo cementless UKR surgery and have similar clinical outcomes to those with normal BMD.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1877056824002160

Comparison of survival between cemented vs cementless ... A recent meta-analysis showed very good results with survival rates at 5, 10 and 15 years for uncemented knee replacements with very low rates of aseptic ...

9. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(22)00958-5/abstract

Is Cementless Total Knee Arthroplasty Safe in Women ... The primary outcome was the incidence of subsidence. Results. There were three asymptomatic cases with definite subsidence and change in ...