Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior Stabilized Total Knee Arthroplasties: A Randomized Controlled Trial
Phase: NA
Conditions: Osteoarthritis, Knee, Knee Arthritis
Sponsor: Aksaray University Training and Research Hospital

 
Official Title:  
Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior 
Stabilized Total Knee Arthroplasties 
NCT Number:  
1585/2017 
Date: 
June 08, 2020 
 
 
 

OBJECTIVE 
Whether ultra-congruent (UC) or posterior cruciate ligament-stabilized (PS) inserts 
should be used in posterior cruciate ligament (PCL)-sacrificing total knee arthroplasty (TKA) 
remains debatable. Therefore, the aim of this prospective randomized controlled study is to 
compare the isokinetic performance and clinical outcomes of these inserts in PCL sacrificing 
TKA. 
DESIGN AND METHODS 
Sixty-six patients diagnosed with primary knee osteoarthritis will be randomly 
assigned to either the UC or the PS group. The Knee Society score (KSS) and isokinetic 
performance results for each patient will be recorded preoperatively and at 3, 6 and 12 months 
postoperatively. The physiatrist performing the isokinetic tests and the patients will be blinded 
to the study groups. 
This study is approved by the institutional review board (IRB) by the “Ankara 
Numune Training and Research Hospital Clinical Research Ethics Committee” ethical 
committee (1585/2017) (Ankara, Turkey) and will be performed in accordance to the 1964 
Helsinki Declaration and its amendments. 
STATISTICAL ANALYSIS PLAN (SAP) 
Sample size estimation is performed using the mean knee extensor peak torque at one 
year postoperatively, 53.9 Nm, and the standard deviation, 12, reported in a prior study [1] 
and G*Power (version 3.1.9.6.) software. A total of 66 patients is estimated to be needed to 
achieve a power of 95% in detecting a 10 Nm difference in the extensor peak torque, with a 
standard deviation of 12, 4 measurements, an effect size of 0.41 and a significance level 
(alpha) of 0.05 using two-way repeated measures ANOVA. All the data will be presented as 
means and standard deviations. Two-way repeated measures ANOVA will be used for the 
statistical analysis of the repeated measurements in the two groups. The statistical calculations 
will be performed with SPSS 22.0 software (IBM SPSS Statistics for Windows, version 22.0. 
Armonk, NY: IBM Corp.). Values of p <0.05 will be considered statistically significant. 
1. Kim JG, Lee SW, Ha JK, Choi HJ, Yang SJ, Lee MY (2011) The effectiveness of 
minimally invasive total knee arthroplasty to preserve quadriceps strength: a randomized 
controlled trial. Knee 18:443–447. https://doi.org/10.1016/j.knee.2010.08.008 11.