Clinical trial NCT04597684: Cemented vs. Cementless TKA
Official title: What Are the Results of Cemented vs. Cementless TKA With the Same Implant Design? A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Total Knee Arthroplasty (TKA)
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Revision for loosening
timeFrame: Within 20 years of study surgery
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.)
timeFrame: PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
measure: The Veterans RAND 12-Item Health Survey (VR-12)
timeFrame: PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
measure: Radiographic evidence of loosening
timeFrame: PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
Other outcomes:
measure: Charlson Comorbidity Index (CCI)
timeFrame: PreOperative
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
Study officials:
affiliation: OrthoCarolina Research Institute, Inc.
name: Keith A Fehring, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.