Cemented vs Cementless Knee Replacement for Knee Osteoarthritis

Overseen By Osteoporosis Clinical Research Program

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Osteoporosis meds, Glucocorticoids

Disqualifiers: Osteoporosis, Rheumatoid arthritis, others

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

Compensation: Varies

Number of Visits: 3

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine femur bone mineral density (BMD) change before and after surgery in patients receiving cemented or cementless total knee arthroplasty (TKA). performed with manual or robotic methods. 100 participants will be enrolled and can expect to be on study for up to 14 months.

Do I need to stop my current medications for the trial?

The trial requires that you do not currently use osteoporosis medications, systemic glucocorticoids, or bone-active medications. If you are taking any of these, you would need to stop before participating.

What data supports the effectiveness of cemented vs cementless knee replacement for knee osteoarthritis?

Research shows that both cemented and cementless knee replacements have similar long-term survival rates, but cementless options may reduce surgery time and the need for post-surgery adjustments. However, cemented replacements might lead to less blood loss during surgery. ^{1 2 3 4 5}

Is knee replacement surgery safe for humans?

Research shows that both cemented and cementless knee replacements are generally safe, but there may be differences in outcomes. Cementless options might reduce surgery time and have fewer complications like pain, especially in newer designs, but cemented options may show less change in bone over time. ^{1 2 6 7 8}

How does cemented vs cementless knee replacement differ from other treatments for knee osteoarthritis?

Cemented and cementless knee replacements are unique because they offer different methods of attaching the artificial joint to the bone. Cemented replacements use a special glue to fix the joint, while cementless replacements rely on the bone growing into the surface of the implant for stability, potentially reducing surgery time and the need for later adjustments. ^{1 3 4 5 9}

Research Team

Brian Nickel, MD

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

This trial is for individuals with knee osteoarthritis or rotator cuff syndrome who require total knee arthroplasty (TKA). Specific eligibility criteria are not provided, but typically participants would need to be suitable candidates for the surgical procedures involved.

Inclusion Criteria

I am 55 or older and have not had joint replacement surgery on the side being considered for a new knee.

My bone density is normal or slightly low without high fracture risk.

Exclusion Criteria

I am currently taking steroids or medications for my bones.

I have rheumatoid arthritis.

25(OH)D less than 20 ng/mL

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo total knee arthroplasty (TKA) with either cemented or cementless implants, using manual or robotic methods. Initial recovery and assessment of leg lean mass change and patient-reported outcomes occur.

2 weeks

1 visit (in-person)

Short-term Follow-up

Participants are monitored for changes in bone mineral density (BMD) and patient-reported outcomes at 3 months post-surgery.

3 months

1 visit (in-person)

Long-term Follow-up

Participants are monitored for changes in bone mineral density (BMD) and patient-reported outcomes at 12 months post-surgery.

12 months

1 visit (in-person)

Treatment Details

Interventions

• Cemented Total Knee Arthroplasty
• Cementless Total Knee Arthroplasty

Trial Overview The study is examining bone density changes in the femur after TKA using either cemented or cementless techniques. It also compares manual versus robotic surgery methods. Participants will be monitored over a period of up to 14 months.

Participant Groups

Group I: Cemented and Robotic Active Control 2 Interventions

Group II: Cementless and Manual Active Control 2 Interventions

Group III: Cementless and Robotic Active Control 2 Interventions

Group IV: Cemented and Manual Active Control 2 Interventions

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

Approved in European Union as Cemented Total Knee Arthroplasty for:

• Severe knee osteoarthritis
• Rheumatoid arthritis
• Traumatic arthritis

Approved in United States as Cemented Total Knee Arthroplasty for:

• Degenerative joint disease
• Rheumatoid arthritis
• Post-traumatic arthritis

Approved in Canada as Cemented Total Knee Arthroplasty for:

• Severe osteoarthritis
• Rheumatoid arthritis
• Traumatic arthritis

Approved in Japan as Cemented Total Knee Arthroplasty for:

• Degenerative joint disease
• Rheumatoid arthritis
• Post-traumatic arthritis

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

In a matched cohort study of 127 patients each, cementless total knee arthroplasty (TKA) resulted in significantly shorter tourniquet times (45.7 minutes) compared to cemented TKA (54.8 minutes), indicating a more efficient surgical process.

The cementless TKA group had a 0% manipulation rate post-surgery, while the cemented group had a 3.1% rate, suggesting that cementless procedures may lead to better postoperative outcomes in terms of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A matched cohort study between cementless TKA and cemented TKA shows a reduction in tourniquet time and manipulation rate. Dubin, JA., Westrich, GH.[2022]

A systematic review of 39 studies involving cementless total knee arthroplasty (TKA) showed that modern cementless implants provide excellent survivorship and patient-reported outcomes, comparable to cemented designs.

Newer generation cementless TKAs demonstrate similar functional outcomes and survivorship rates as cemented TKAs, but further long-term randomized trials are needed for more definitive comparisons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newer Generation of Cementless Total Knee Arthroplasty: A Systematic Review. Haeberle, HS., Salem, HS., Ehiorobo, JO., et al.[2020]

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]

Cemented total knee arthroplasty (TKA) resulted in better postoperative Knee Society Scores and range of motion compared to cementless TKA, based on a meta-analysis of 18 studies involving 5,222 patients with a follow-up of around 107 months.

While cemented TKA had less perioperative blood loss, it was associated with a higher rate of manipulation under anesthesia and aseptic loosening, indicating that both fixation methods can achieve similar functional outcomes and reoperation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemented Total Knee Arthroplasty Shows Less Blood Loss but a Higher Rate of Aseptic Loosening Compared With Cementless Fixation: An Updated Meta-Analysis of Comparative Studies. Mercurio, M., Gasparini, G., Sanzo, V., et al.[2022]

In a study of 261 patients with a mean follow-up of 23.8 years, cementless total knee arthroplasties (TKAs) showed comparable long-term clinical outcomes and survival rates to cemented TKAs, with survival rates of 97% and 98% respectively at 25 years.

Both cementless and cemented TKAs demonstrated no significant differences in knee function scores or prevalence of osteolysis, indicating that cementless TKAs can be a safe and effective alternative to cemented options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 22 to 25-Year Survival of Cemented and Cementless Total Knee Arthroplasty in Young Patients. Kim, YH., Park, JW., Jang, YS.[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]

In a study of 806 total knee arthroplasties (TKAs) with an average follow-up of 3.8 years for cemented and 3.4 years for cementless procedures, patients with cementless TKAs reported better overall knee function scores compared to those with cemented TKAs (86 vs. 80 points).

Both cemented and cementless TKAs showed similar rates of complications and functional improvements, indicating that the choice of fixation method does not significantly affect early clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cementless and Cemented Dual-Pivot Total Knee Arthroplasty: A Matched Comparison With a Minimum Two-Year Follow-Up. Meding, JB., Meding, LK.[2023]

In a study of 406 obese patients (BMI ≥35 kg/m2) undergoing total knee arthroplasty (TKA), both cemented and cementless procedures showed similar postoperative outcomes and improvements over 2 years, indicating that both methods are effective for this population.

The 7-year survivorship rates free from aseptic revision were also comparable between the two groups (99.0% for cemented vs 99.5% for cementless), suggesting that both types of TKA provide durable fixation in obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemented Versus Cementless Total Knee Arthroplasty in Obese Patients With Body Mass Index ≥35 kg/m2: A Contemporary Analysis of 812 Patients. Goh, GS., Fillingham, YA., Sutton, RM., et al.[2022]

In a study of 109 total knee arthroplasties with an average follow-up of over 8 years, both cemented and cementless tibial components showed high survival rates, with 100% for cementless and 97.1% for cemented, indicating that cementless fixation is a reliable option.

Postoperative knee scores were significantly higher in the cementless group compared to the cemented group, suggesting better clinical outcomes, although overall function and range of motion were similar between the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival rate of cemented versus cementless tibial component in primary total knee arthroplasty over 5 years of follow-up: comparative study of 109 prostheses. Pacoret, V., Kalk, E., Labattut, L., et al.[2021]

References

1. India pubmed.ncbi.nlm.nih.gov

A matched cohort study between cementless TKA and cemented TKA shows a reduction in tourniquet time and manipulation rate. [2022]

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

Newer Generation of Cementless Total Knee Arthroplasty: A Systematic Review. [2020]

3. 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]

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

Cemented Total Knee Arthroplasty Shows Less Blood Loss but a Higher Rate of Aseptic Loosening Compared With Cementless Fixation: An Updated Meta-Analysis of Comparative Studies. [2022]

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

The 22 to 25-Year Survival of Cemented and Cementless Total Knee Arthroplasty in Young Patients. [2021]

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

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

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

Cementless and Cemented Dual-Pivot Total Knee Arthroplasty: A Matched Comparison With a Minimum Two-Year Follow-Up. [2023]

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

Cemented Versus Cementless Total Knee Arthroplasty in Obese Patients With Body Mass Index ≥35 kg/m2: A Contemporary Analysis of 812 Patients. [2022]

9. France pubmed.ncbi.nlm.nih.gov

Survival rate of cemented versus cementless tibial component in primary total knee arthroplasty over 5 years of follow-up: comparative study of 109 prostheses. [2021]