Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
17 participants
INTERVENTIONAL
2020-09-29
2021-10-21
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Treatment/Intervention
Total Knee Arthroplasty (TKA) with cementless knees
Cementless Total Knee Arthroplasty
Total Knee Arthroplasty (TKA) with cementless knees
Control
Total Knee Arthroplasty (TKA) with cemented knees
Cemented Total Knee Arthroplasty
Total Knee Arthroplasty (TKA) with cemented knees
Interventions
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Cementless Total Knee Arthroplasty
Total Knee Arthroplasty (TKA) with cementless knees
Cemented Total Knee Arthroplasty
Total Knee Arthroplasty (TKA) with cemented knees
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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OrthoCarolina Research Institute, Inc.
OTHER
Responsible Party
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Principal Investigators
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Keith A Fehring, MD
Role: PRINCIPAL_INVESTIGATOR
OrthoCarolina Research Institute, Inc.
Locations
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OrthoCarolina Research Institute
Charlotte, North Carolina, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HK226
Identifier Type: -
Identifier Source: org_study_id
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