Cemented vs. Cementless TKA

Not Applicable

Terminated

• Conditions: Total Knee Arthroplasty (TKA)
• Interventions: Procedure: Cementless Total Knee Arthroplasty; Procedure: Cemented Total Knee Arthroplasty

• Registration Number: NCT04597684
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

Brief 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.

Study Timeline

• Study Start: 2020-09-29
• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Primary Completion: 2021-10-21
• Study Completion: 2021-10-21
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Evaluation for TKA at OrthoCarolina
2. Evaluated and scheduled for TKA by Drs. Keith Fehring, Bo Mason, William Griffin, Thomas Fehring, or Jesse Otero
3. Determined by the above surgeon to be a candidate for the Attune Posterior Stabilized knee system, with the patella to be resurfaced during surgery
4. >18 years of age at enrollment

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Exclusion Criteria

1. Previous surgery with hardware on the joint of interest
2. >= 65 years old at the time of TKA surgery
3. Previous diagnosis of inflammatory disease (RA, inflammatory arthropathy, any autoimmune disease)
4. BMI <= 40
5. Physician discretion due to not being able to follow standard-of-care (SOC) TKA follow up protocol
6. History of contralateral TKA
7. Current Tobacco Use

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment/Intervention	Cementless Total Knee Arthroplasty	Total Knee Arthroplasty (TKA) with cementless knees
Control	Cemented Total Knee Arthroplasty	Total Knee Arthroplasty (TKA) with cemented knees

Primary Outcome Measures

Name	Time	Method
Revision for loosening	Within 20 years of study surgery	Did the subject have a revision procedure due to loosening (yes/no)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

OrthoCarolina Research Institute; 🇺🇸 Charlotte, North Carolina, United States