Cemented vs. Cementless TKA

Study Overview
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Brief Summary
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The investigators are evaluating an implant (Depuy Attune TKA) that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options. The investigators are conducting a study to compare the results of this cementless design to the cemented design of the same implant.

Detailed Description
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Aseptic Loosening remains a leading cause for revision following TKA. Cemented TKAs have shown high failure rates in obese and younger populations. There is renewed interest in biologic fixation of total knee components with a more active and younger patient population, as well as long term alternatives in obese patients receiving TKA. Questions remain whether cemented or cementless long term fixation is superior in total knee arthroplasty in these populations. Potential benefits of cementless fixation include preservation of bone, decreased operative times, and elimination of complications specific to cemented components. Older cementless TKA designs had higher failure rates due to poor fixation methods, patch porous coating on the implant, poor tibial locking mechanisms and the use of conventional polyethylene. The combination of these factors led to unacceptable failure rates in these devices. Newer designs have looked to improve these flaws with advances in the biologic interface, use of highly porous metals, improved locking mechanisms, and cross-linked polyethylene. Recently, cementless implants with these improved design features have shown improved long term outcomes of cementless components versus their cemented predecessors. The combination of these improved long term outcomes in younger, more active population warrant further investigation of cementless components in TKA. There is a need for more durable, long term fixation in all implants treating obese, as well as young active patients. The investigators are evaluating an implant (Depuy Attune TKA) that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options. The investigators are conducting a study to compare the results of this cementless design to the cemented design of the same implant.

Official Title
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What Are the Results of Cemented vs. Cementless TKA With the Same Implant Design? A Randomized Clinical Trial.

Conditions
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Total Knee Arthroplasty (TKA)

Intervention / Treatment
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* Procedure: Cementless Total Knee Arthroplasty
* Procedure: Cemented Total Knee Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evaluation for TKA at OrthoCarolina Evaluated and scheduled for TKA by Drs. Keith Fehring, Bo Mason, William Griffin, Thomas Fehring, or Jesse Otero Determined by the above surgeon to be a candidate for the Attune Posterior Stabilized knee system, with the patella to be resurfaced during surgery >18 years of age at enrollment Exclusion Criteria: Previous surgery with hardware on the joint of interest >= 65 years old at the time of TKA surgery Previous diagnosis of inflammatory disease (RA, inflammatory arthropathy, any autoimmune disease) BMI <= 40 Physician discretion due to not being able to follow standard-of-care (SOC) TKA follow up protocol History of contralateral TKA Current Tobacco Use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment/Intervention<br>Total Knee Arthroplasty (TKA) with cementless knees | Procedure: Cementless Total Knee Arthroplasty<br>* Total Knee Arthroplasty (TKA) with cementless knees<br>* Other names: Treatment/Intervention;|
| Active Comparator: Control<br>Total Knee Arthroplasty (TKA) with cemented knees | Procedure: Cemented Total Knee Arthroplasty<br>* Total Knee Arthroplasty (TKA) with cemented knees<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision for loosening | Did the subject have a revision procedure due to loosening (yes/no) | Within 20 years of study surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.) | Patient-reported outcome of knee stiffness, pain, and function of daily living. | PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year | 
| The Veterans RAND 12-Item Health Survey (VR-12) | General Health survey | PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year | 
| Radiographic evidence of loosening | Radiographic evidence of loosening | PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year |