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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary study objective is to evaluate a cementless partial knee system that has a modular 3-D printed porous metal tibial component and a cemented partial knee system. The hypothesis is that at minimum 2-year follow-up, fixed bearing medial partial knee replacements using cementless and cemented fixation will demonstrate no differences in clinical outcome.

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 data supports the effectiveness of the treatment Cementless fixation for partial knee replacement?

Research shows that cementless partial knee replacements have a slightly higher 10-year implant survival rate compared to cemented ones, with 93% survival for cementless versus 90% for cemented. This suggests that cementless fixation may be more durable over time. ^{1 2 3 4 5}

Is cementless partial knee replacement safe for humans?

Research shows that cementless partial knee replacements generally have good long-term survival rates and low complication rates, although there is a risk of fractures around the implant. Studies comparing cemented and cementless methods found similar safety outcomes, with no significant differences in complications or implant survival. ^{3 6 7 8 9}

How does cementless fixation differ from other treatments for partial knee replacement?

Cementless fixation for partial knee replacement is unique because it aims to achieve a biological bond between the implant and bone, potentially reducing issues like cement fragmentation and loosening seen with cemented implants. This method may be particularly beneficial for younger patients with good bone quality, as it preserves bone stock and avoids the need for cement. ^{4 8 10 11 12}

Research Team

Robert Hopper

Principal Investigator

Anderson Orthopaedic Research Institute

Eligibility Criteria

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.

I am between 18 and 85 years old.

Exclusion Criteria

Grossly porotic bone

Current smokers

Non-English speakers

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Comparison of the 10-year outcomes of cemented and cementless unicompartmental knee replacements: data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of five-year clinical outcomes of 524 cemented and cementless medial unicompartmental knee replacements. [2022]

3. India pubmed.ncbi.nlm.nih.gov

An Early Periprosthetic Fracture of a Cementless Oxford Unicompartmental Knee Arthroplasty: Risk Factors and Mitigation Strategies. [2022]

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

Improved fixation in cementless unicompartmental knee replacement: five-year results of a randomized controlled trial. [2022]

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

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Ten-year survival and seven-year functional results of cementless Oxford unicompartmental knee replacement: A prospective consecutive series of our first 1000 cases. [2022]

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

Cemented versus cementless fixation of a tibial component in LCS mobile-bearing total knee arthroplasty performed by a single surgeon. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Five-year results of a randomised controlled trial comparing cemented and cementless Oxford unicompartmental knee replacement using radiostereometric analysis. [2021]

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

Cementless Versus Cemented Tibial Fixation in Posterior Stabilized Total Knee Replacement: A Randomized Trial. [2021]

10. Italy pubmed.ncbi.nlm.nih.gov

Cementless knee arthroplasty. [2020]

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

No component loosening of a cementless deep dish rotating platform knee at a 5-year follow-up. [2023]

12. England 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. [2019]