Cemented vs. Cementless TKA | NCT04597684

Studies
Cemented vs. Cementless TKA

NCT04597684

Sponsor

OrthoCarolina Research Institute, Inc.

Status

Terminated

Last Update Posted

Apr 8, 2022Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Total Knee Arthroplasty (TKA)

Interventions

Cementless Total Knee Arthroplasty
Cemented Total Knee Arthroplasty

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment volume below acceptable accrual rate.

Expanded Access Info

Start Date

Sep 29, 2020Actual

Primary Completion Date

Oct 21, 2021Actual

Completion Date

Oct 21, 2021Actual

First Submitted Date

Oct 9, 2020

First Submission Date that Met QC Criteria

Oct 15, 2020

First Posted Date

Oct 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2022

Last Update Posted Date

Apr 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment/Intervention	Active Comparator	Total Knee Arthroplasty (TKA) with cementless knees	Procedure: Cementless Total Knee Arthroplasty
Control	Active Comparator	Total Knee Arthroplasty (TKA) with cemented knees	Procedure: Cemented Total Knee Arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cementless Total Knee Arthroplasty	Procedure	Total Knee Arthroplasty (TKA) with cementless knees	Treatment/Intervention

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Keith A Fehring, MD	OrthoCarolina Research Institute, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OrthoCarolina Research Institute		Charlotte	North Carolina	28207	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18929686	Background	Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
29275115	Background

ID	Term
D013812	Therapeutics
D008722	Methods