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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different knee replacement surgery methods affect thigh bone health. Participants will receive either a cemented (Cemented Total Knee Arthroplasty) or cementless (Cementless Total Knee Arthroplasty) knee replacement, with surgery performed manually or using a robot. It targets individuals with knee osteoarthritis who have not had a joint replacement on the affected knee. Suitable candidates have normal bone health or slight bone density loss but do not have osteoporosis or a history of bone fractures after age 50. The study will last about 14 months. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future knee replacement procedures.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both cemented and cementless total knee replacements are generally safe and well-tolerated. Studies have found that patients with cemented knee replacements often experience better improvements in knee function. However, both types yield similar long-term results and patient satisfaction.

Cemented knee replacements carry a higher risk of bone loss around the implant but remain a reliable option. Cementless knee replacements are gaining popularity due to their strong attachment and good short- to mid-term results. Although there are concerns about the implant loosening without infection, it generally performs well.

Both treatments offer similar pain relief and functional improvements. These findings suggest that both options are safe, each with distinct advantages and disadvantages. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these knee replacement techniques because they explore different methods of securing the knee implant, either with cement or without it. The cemented approach is well-known for its reliability, using a special adhesive to fix the implant, which provides immediate stability. On the other hand, the cementless method encourages natural bone growth into the implant, potentially offering a longer-lasting bond. Additionally, both approaches are being compared using manual and robotic-assisted surgeries, which could enhance precision and recovery. This exploration could lead to more personalized and effective treatments for knee osteoarthritis, offering patients better long-term outcomes.

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

This trial will compare cemented and cementless total knee replacements for treating knee osteoarthritis. Research has shown that both options are effective. Participants may receive a cemented knee replacement, known for its long-standing use and ability to improve knee function, particularly in the short term. Studies have found that patients with cemented knees often experience significant improvements in knee function. Alternatively, participants may receive a cementless knee replacement, which also performs well, with similar long-term success and function. Some research suggests that cementless options might last longer without becoming loose. Both types are good choices, with similar effectiveness over time. ^{1 3 6 7 8}

Who Is on the Research Team?

Brian Nickel, MD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Cemented and Manual Active Control 2 Interventions

Group II: Cemented and Robotic Active Control 2 Interventions

Group III: Cementless and Manual Active Control 2 Interventions

Group IV: Cementless and Robotic 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+

Published Research Related to This Trial

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]

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]

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 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]

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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9608915/

Patient-reported outcomes following cemented versus ... Patients who underwent cemented TKA had a statistically significant greater improvement in knee function scores (KOOS-Jr.) than did those having a cementless ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540323002711

Cementless and Cemented Dual-Pivot Total Knee ... At final follow-up, the average Knee Injury and Osteoarthritis Outcome Score for Joint Replacement was higher in the cementless group (86 points (range, 64-100) ...

3. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-04966-8

Fixation options for total knee arthroplasty: a comprehensive ... Cemented fixation has long been regarded as the gold standard for TKA, boasting high survival rates over long-term follow-ups [6,7,8]. Non- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06929871

Study Details | NCT06929871 | Mako Cementless TKA vs ... Findings of this study will enable an improved understanding of the radiological, clinical and functional benefits of cementless fixation compared to cemented ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8513310/

Long-term effects of cemented and cementless fixations ... Long-term follow-up verified that cementless and cemented fixation have similar prosthesis survival rates, clinical scores and mobility.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540325004693

To Cement or Not? Ten-Year Results of a Prospective ... Cementless and cemented TKA had equivalent patient-reported outcomes and survivorship at 10-year follow-up. Cemented fixation had a higher rate of osteolysis ...

7. sicot-j.org sicot-j.org/10.1051/sicotj/2024017

Survivorship and complications of cementless compared to ... Cemented TKAs have long been considered the gold standard, with 80%–90% of all TKAs performed [2, 3]. In the past decade, the reasons for revising total knee ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1505467

A Randomized, Controlled Trial of Total Knee Replacement Treatment with total knee replacement followed by nonsurgical treatment resulted in greater pain relief and functional improvement after 12 months than did ...