Cemented vs. Cementless TKA

NCT04597684 | Terminated DMC

• 1 other identifier: HK226
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty (TKA)

Outcome Measures

Primary Outcomes (1)

• Revision for loosening

  Did the subject have a revision procedure due to loosening (yes/no)

  Within 20 years of study surgery

Secondary Outcomes (3)

• 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

• 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

• Radiographic evidence of loosening

  PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year

Other Outcomes (1)

• Charlson Comorbidity Index (CCI)

  PreOperative

Study Arms (2)

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

Cementless Total Knee Arthroplasty PROCEDURE

Total Knee Arthroplasty (TKA) with cementless knees

Also known as: Treatment/Intervention

Treatment/Intervention

Cemented Total Knee Arthroplasty PROCEDURE

Total Knee Arthroplasty (TKA) with cemented knees

Also known as: Control

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Related Publications (8)

• 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.

  PMID: 18929686 BACKGROUND

• Miller AJ, Stimac JD, Smith LS, Feher AW, Yakkanti MR, Malkani AL. Results of Cemented vs Cementless Primary Total Knee Arthroplasty Using the Same Implant Design. J Arthroplasty. 2018 Apr;33(4):1089-1093. doi: 10.1016/j.arth.2017.11.048. Epub 2017 Dec 2.

  PMID: 29275115 BACKGROUND

• Nam D, Lawrie CM, Salih R, Nahhas CR, Barrack RL, Nunley RM. Cemented Versus Cementless Total Knee Arthroplasty of the Same Modern Design: A Prospective, Randomized Trial. J Bone Joint Surg Am. 2019 Jul 3;101(13):1185-1192. doi: 10.2106/JBJS.18.01162.

  PMID: 31274720 BACKGROUND

• Fricka KB, Sritulanondha S, McAsey CJ. To Cement or Not? Two-Year Results of a Prospective, Randomized Study Comparing Cemented Vs. Cementless Total Knee Arthroplasty (TKA). J Arthroplasty. 2015 Sep;30(9 Suppl):55-8. doi: 10.1016/j.arth.2015.04.049. Epub 2015 Jun 3.

  PMID: 26118567 BACKGROUND

• Abdel MP, Bonadurer GF 3rd, Jennings MT, Hanssen AD. Increased Aseptic Tibial Failures in Patients With a BMI >/=35 and Well-Aligned Total Knee Arthroplasties. J Arthroplasty. 2015 Dec;30(12):2181-4. doi: 10.1016/j.arth.2015.06.057. Epub 2015 Jul 2.

  PMID: 26220103 BACKGROUND

• Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.

  PMID: 22398175 BACKGROUND

• Brown TE, Harper BL, Bjorgul K. Comparison of cemented and uncemented fixation in total knee arthroplasty. Orthopedics. 2013 May;36(5):380-7. doi: 10.3928/01477447-20130426-10.

  PMID: 23672897 BACKGROUND

• Lombardi AV Jr, Berasi CC, Berend KR. Evolution of tibial fixation in total knee arthroplasty. J Arthroplasty. 2007 Jun;22(4 Suppl 1):25-9. doi: 10.1016/j.arth.2007.02.006.

  PMID: 17570273 BACKGROUND

MeSH Terms

Interventions

Therapeutics; Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Keith A Fehring, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 22, 2020
• Study Start: September 29, 2020
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)