Cemented vs. Cementless TKA

March 31, 2022 updated by: OrthoCarolina Research Institute, Inc.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment/Intervention
Total Knee Arthroplasty (TKA) with cementless knees
Procedure: Cementless Total Knee Arthroplasty
Total Knee Arthroplasty (TKA) with cementless knees
Other Names:
  • Treatment/Intervention
Active Comparator: Control
Total Knee Arthroplasty (TKA) with cemented knees
Procedure: Cemented Total Knee Arthroplasty
Total Knee Arthroplasty (TKA) with cemented knees
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revision for loosening
Time Frame: Within 20 years of study surgery
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.)
Time Frame: 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.
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)
Time Frame: PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
General Health survey
PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
Radiographic evidence of loosening
Time Frame: PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
Radiographic evidence of loosening
PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Charlson Comorbidity Index (CCI)
Time Frame: PreOperative
Evaluation of a subject's mortality risk
PreOperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrthoCarolina Research Institute, Inc.

Investigators

  • Principal Investigator: Keith A Fehring, MD, OrthoCarolina Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2020

Primary Completion (Actual)

October 21, 2021

Study Completion (Actual)

October 21, 2021

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • HK226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual Participant Data (IPD) will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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