Cemented vs Cementless Knee Replacement for Knee Osteoarthritis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Wisconsin, Madison
No Placebo Group
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.
Is Cemented Total Knee Arthroplasty a promising treatment for knee osteoarthritis?Cemented Total Knee Arthroplasty is a promising treatment because it shows less blood loss during surgery and has a similar long-term survival rate compared to cementless options. It also has a lower incidence of needing further manipulation after surgery.24568
What safety data is available for cemented vs. cementless knee replacement?The safety data for cemented and cementless knee replacements includes several studies: A matched cohort study found that cementless TKA may reduce tourniquet time and manipulation rates. A systematic review highlighted ongoing debates but noted similar survivorship and patient-reported outcomes for newer cementless TKAs. A study comparing cemented, press-fit, and HA-coated interfaces found less axial migration and fewer radiographic changes with cemented interfaces, though uncemented groups reported more pain. Another study reported similar early clinical and radiographic outcomes for cementless and cemented TKAs using dual-pivot articulation. Lastly, a study on obese patients suggested that cementless TKA might offer more durable fixation compared to cemented TKA.13679
What data supports the idea that Cemented vs Cementless Knee Replacement for Knee Osteoarthritis is an effective treatment?The available research shows that both cemented and cementless knee replacements are effective treatments for knee osteoarthritis. One study found that cementless knee replacements can reduce the time spent in surgery and the need for additional procedures. Another study indicated that both types of knee replacements have similar long-term success rates. However, cemented knee replacements may lead to less blood loss during surgery, but they also have a higher chance of the implant becoming loose over time. Overall, both methods have their advantages and are effective in treating knee osteoarthritis.23468
Do I have to stop taking my current medications for this trial?The trial requires that you do not use osteoporosis medications or systemic glucocorticoids or bone-active medications. If you are currently taking these, you would need to stop to participate.
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.
I have been diagnosed with osteoporosis.
I have taken medication for osteoporosis.
Participant Groups
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.
4Treatment groups
Active Control
Group I: Cemented and RoboticActive Control2 Interventions
Group II: Cementless and ManualActive Control2 Interventions
Group III: Cementless and RoboticActive Control2 Interventions
Group IV: Cemented and ManualActive Control2 Interventions
Cemented Total Knee Arthroplasty is already approved in European Union, United States, Canada, Japan, Australia 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
🇦🇺 Approved in Australia as Cemented Total Knee Arthroplasty for:
- Severe osteoarthritis
- Rheumatoid arthritis
- Traumatic arthritis
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
UW School of Medicine and Public HealthMadison, WI
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
References
A comparison between cemented, press-fit, and HA-coated interfaces in Kinemax total knee replacement. [2019]There are possible advantages of using uncemented fixation in total knee replacement. In this prospective randomised multi-centre study, a comparison was made between cemented and two types of uncemented fixation for the Kinemax design. There were 12-14 cases in each group. Beads were inserted in the bones from which component migration was measured at time intervals up to 2 years. The axial migrations were significantly less for cemented and HA-coating, compared with press-fit, at all time intervals. The clinical data showed no differences at 2 years except for more cases of pain in the uncemented groups. Radiographically, the cemented interfaces showed the least change, press-fit showed a radiolucent line and a radiodense line, and HA showed a diffuse radiodensity adjacent to the components. It was concluded that for the Kinemax design of tibial component, press-fit was inferior to cemented, but that there was the potential for designing a special component for uncemented fixation for which HA-coating would be an advantage.
Similar survival between uncemented and cemented fixation prostheses in total knee arthroplasty: a meta-analysis and systematic comparative analysis using registers. [2021]The purpose of this analysis was to determine whether uncemented total knee arthroplasty performs as well as cemented total knee arthroplasty.
Newer Generation of Cementless Total Knee Arthroplasty: A Systematic Review. [2020]Although the use of cementless implants in total knee arthroplasty (TKA) has increased in recent years, there is still ongoing debate regarding the optimal method of fixation. The purpose of this review was to evaluate the evidence regarding cementless versus cemented total knee arthroplasty (TKA) with regard to: (1) all-cause survivorship and aseptic survivorship; and (2) patient-reported outcome measures (PROMs) of newer generation TKAs.
The 22 to 25-Year Survival of Cemented and Cementless Total Knee Arthroplasty in Young Patients. [2021]Despite cementless total knee arthroplasties (TKAs) have potential advantages over cemented TKAs, there are conflicting results. The purpose of the present study is to determine the long-term clinical and radiographic results, the survival rate, and the prevalence of osteolysis of cemented vs cementless TKAs.
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]Knee osteoarthritis is the main indication for primary total knee arthroplasty (TKA). It is now accepted that cementless implantation of the femoral component provides equivalent results to cemented one, however, the optimal fixation method of the tibial component remains controversial. The purpose of this study was to compare the survivorship of cemented versus cementless tibial baseplate in primary total knee arthroplasty.
A matched cohort study between cementless TKA and cemented TKA shows a reduction in tourniquet time and manipulation rate. [2022]Cementless total knee arthroplasty (TKA) is now becoming more acceptable with the advent of newer ongrowth constructs and better initial fixation. It has been proposed that cementless TKA may save OR time and result in a lower incidence of manipulation. This study was designed to assess the difference between cemented and cementless TKA.
Cemented Versus Cementless Total Knee Arthroplasty in Obese Patients With Body Mass Index ≥35 kg/m2: A Contemporary Analysis of 812 Patients. [2022]Cemented total knee arthroplasty (TKA) has been shown to have higher failure rates in obese patients, and cementless TKA may provide more durable fixation. This study compared outcomes and survivorship of obese patients undergoing cemented and cementless TKA of the same modern design.
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]The aim of this study was to update the current evidence on functional outcomes, complications, and reoperation rates between cemented and cementless total knee arthroplasty (TKA) by evaluating comparative studies published over the past 15 years.
Cementless and Cemented Dual-Pivot Total Knee Arthroplasty: A Matched Comparison With a Minimum Two-Year Follow-Up. [2023]With the use of newer biomaterials, many authors have reported similar results between cementless and cemented total knee arthroplasty (TKA). The purpose of this study was to compare the early clinical and radiographic outcomes of cementless and cemented TKA using the same dual-pivot articulation.