NCT04597684

Cemented vs. Cementless TKA

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: OrthoCarolina Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Total Knee Arthroplasty (TKA)

Interventions

Type	Name	Description
PROCEDURE	Cementless Total Knee Arthroplasty	Total Knee Arthroplasty (TKA) with cementless knees
PROCEDURE	Cemented Total Knee Arthroplasty	Total Knee Arthroplasty (TKA) with cemented knees

Timeline

• Start date: 2020-09-29
• Primary completion: 2021-10-21
• Completion: 2021-10-21
• First posted: 2020-10-22
• Last updated: 2022-04-08

Locations

1 site across 1 country: United States