Evaluation of Zimmer® iASSIST™ vs. Conventional Instrumentation in Total Knee Arthroplasty: Radiographic, Clinical and Economic Outcomes
Phase: NA
Conditions: Avascular Necrosis, Post-traumatic; Arthrosis, Knee Osteoarthritis
Sponsor: Zimmer, GmbH

iASSIST vs. Conventional in TKA 
 
2016-08-12- Rev. 1 
Protocol # CSE2012-05K 
 
Page 1 of 3 
 
 
 
Evaluation of Zimmer® iASSIST™ vs. conventional instrumentation in 
Total Knee Arthroplasty: radiographic, clinical and economic 
outcomes 
 
 
 
Multicenter, prospective, randomized, non-controlled, and comparative 
 
 
 
PROTOCOL NO. CSE2012-05K 
 
 
NCT NUMBER: NCT03111407 
 
 
 
PROTOCOL VERSION: 
2016-08-12 - REV. 1 
 
 
 
 
 
 
 
 
SPONSOR: 
Zimmer GmbH  
SULZERALLEE 8  
8404 WINTERTHUR 
SWITZERLAND 
 
 
 
 
 
 

iASSIST vs. Conventional in TKA 
 
2016-08-12- Rev. 1 
Protocol # CSE2012-05K 
 
Page 2 of 3 
 
Title: Evaluation of Zimmer® iASSIST™ vs. conventional instrumentation in Total Knee 
Arthroplasty: radiographic, clinical and economic outcomes 
Protocol No. CSE2012-05K 
Sponsor Zimmer Inc. 
Study Type Clinical 
Objectives: The purpose of this prospective study is to evaluate Zimmer® iASSIST™ with respect 
to radiographic, clinical and economic outcomes and compared to conventional 
instrumentation in primary total knee arthroplasty (Persona®LPS). 
Endpoints: Primary endpoint: 
• 
The primary endpoint is defined as component alignment as determined 
using long leg X-Rays and/or CT-scan 
Secondary endpoints: 
• 
Knee Society Score 
• 
EuroQol-5D scoring system 
• 
Operating room time  
• 
Blood loss and complications 
Target 
Population: 
Patients over 18 years old with indication of primary knee arthroplasty and 
meeting the inclusion/exclusion criteria stated in the protocol. 
Study Design: Multicenter, prospective, randomized, non-controlled, and comparative 
Number of 
Cases: 
25 cases (15 iASSIST and 10 conventional) per site. Minimum 3 sites. Total 75 
cases (45 iASSIST and 30 conventional). 
Length of 
Study: 
24 months, giving 6-7 months of enrollment and 12 month follow-up of each 
enrolled subject.   All subjects will be assessed pre-operatively, operatively, and at 
3-month (±2 weeks) and 12-month (±1) post-operatively 
Study Device: Zimmer® iASSIST™ Knee 
Scores: 
a. Knee Society Score 
b. EuroQol-5D - Version EQ-5D-3L 
Performance 
Assessment: 
Quarterly: evaluating number of surgeries, patient’s follow-up and post-op 
imaging. Electronic data transmission as required. 
Statistical 
Reporting: 
Descriptive statistics for the values of the angles (N, mean, median, min, max, SD) 
will be calculated by treatment group as well as success rates. Significance level of 
0.05 will be considered 
 
 
 
 
 
 
 
 

iASSIST vs. Conventional in TKA 
 
2016-08-12- Rev. 1 
Protocol # CSE2012-05K 
 
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Statistical Methods 
An independent statistician will perform the statistical analyses. Unless otherwise noted, all inference 
tests will be performed at alpha = 0.05. 
 
Primary endpoints: 
The primary angle endpoint will be component alignment as determined using long leg X-Rays and/or 
CT-scan.  Secondary angle endpoints will be Knee Society Score, EuroQol-5D scoring system, operating 
room time, blood loss and complications. For each subject, each of these angles will be classified as 
either falling within an acceptable range (i.e. success) or not falling within an acceptable range (i.e. 
failure). Descriptive statistics for the values of the angles (N, mean, median, min, max, SD) will be 
calculated by treatment group as well as success rates (percent successes). The null and alternative 
hypotheses for each of these angle endpoints are respectively as follows: 
 
i.e. v/v angle  
Ho: The iASSIST v/v angle success rate is less than or equal to the conventional v/v angle success rate. 
Ha: The iASSIST v/v angle success rate is greater than the conventional v/v angle success rate. 
 
A secondary analysis will be conducted for each endpoint using a one-sided variance ratio test on the 
following secondary null and alternative hypotheses, respectively. 
 
Ho: V1 < V2 
Ha: V1 > V2 
 
Where: 
V1 = The variance of the conventional surgery group 
V2 = The variance of the iASSIST group 
 
Secondary Endpoints: 
 
Secondary non-angle endpoints will include Knee Society Scores and EQ-5D.  Total scores for each will 
be tested for treatment group differences using a two-way ANOVA model with terms for treatment, 
site and treatment-by-site interaction. If the treatment-by-site interaction term is non-significant at 
alpha=0.10 it may be dropped from the model for the final analysis.