Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
Conditions: Osteoarthitis, Arthritis Knee, Joint Diseases, Avascular Necrosis, Rheumatoid Arthritis of Knee
Sponsor: MicroPort Orthopedics Inc.

 
 
 
NITRX CLINICAL 
STUDY 
Primary Investigator: Dr. Alexander Sah 
Observational Clinical 
Study on Evolution 
NitrX   
 
August 01, 2025 
 

 
 
1 
 
TABLE OF CONTENTS 
Background ...................................................................................................................................................... 2 
Synopsis ............................................................................................................................................................ 2 
Scope ................................................................................................................................................................. 2 
Site Responsibility .......................................................................................................................................... 2 
Data Collection and Parameters ................................................................................................................ 3 
Data Collection Plan ......................................................................... Error! Bookmark not defined. 
SCOPE ................................................................................................................................................................ 4 
 
 
 

 
 
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Background  
MicroPort Orthopedics, Inc. (MPO) and the site(s) would like to coordinate the collection of 
clinical data that may be used for regulatory and research purposes. The specific data to be 
collected is in the “Data Collection and Parameters.” The site(s) will provide MPO with 
anonymized, de-identified data as requested, understanding the site’s overriding 
obligations about patient care and patient confidentiality. 
 
Synopsis  
Study Title 
Evolution NitrX Observational Study 
Study Rationale 
To evaluate the safety and performance of Evolution NitrX TKA  
Study Design 
Single Center observational study  
Study Sites 
Dr Alexander Sah (PI) 
Sample Size 
100 
Visit Schedule 
subject schedule will consist of the following time points: 
Study Timeline  
3 yr follow up within 2025 
5 yr follow up within 2027 
7 years follow up 2029 
10 years follow up 2032 
Inclusion Criteria 
• 
Subjects > 18 years of age at the time of surgery 
• 
Subjects who were implanted with the Evolution NitrX SKU #s listed below) in MicroPort Orthopedics’ 
intended patient population listed within the Instructions for Use (IFU). 
• 
Willing and able to participate in the clinical study 
Exclusion Criteria 
• 
Subjects without follow-up history 
• 
Subjects not meeting the inclusion criteria 
• 
Contraindications as listed in the IFU 
• 
Currently enrolled in another study that could affect the endpoints of this protocol.  
• 
Has a medical or mental health condition, as judged by the investigator, that would affect the endpoints of 
this protocol.  
 
Objectives 
Outcome Measures 
Primary 
Survivorship (KM) 
Kaplan Meier survival rates at each time point 
Secondary 
PROMS 
KOOS Jr 
SAE including Revisions 
Track revisions and reason for revisions throughout the 
study 
 
Scope 
Both MPO and the site(s) agree that the site shall be the sole owner of the data and all 
intellectual property rights in such data. The site will grant MPO the ability to use the 
aggregated and/or anonymized data for regulatory and research. The opportunity for MPO 
and the site(s) to collaborate on further use of the data for publication or abstract 
submissions for medical or professional conferences may be pursued later. 
 
Site Responsibility  
The site will maintain strict confidentiality regarding any data about subjects. It will control the 
subjects' data as defined in relevant data protection laws or regulations applicable to the site. 

 
 
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The site will be responsible for obtaining approvals from an Institutional Review Board (IRB) for 
data collection. The site will be the sole owner of the data and all related intellectual property 
rights. However, the site will grant MPO the ability to use, edit, compile, and disseminate the 
data for regulatory and research activities. The site will not disclose any patient-identifiable 
information to MPO. The site will provide data on patients solely in aggregated and/or 
anonymized form, preventing MPO from identifying individual patients. 
 
Data Collection and Parameters 
Data Collection Plan 
• 100 cases with min 10-year follow-up, implanted with Evolution NitrX, will be 
included in this study. 
• Data collection will be prospective.  
• Patient preop and intra-op information has been collected in study 20K001, and 
this study is a continuation of that study.  
• Information regarding adverse events or revisions after surgery will be obtained 
from patient charts. 
• IRB will be notified of the change in study collection. 
• Site will ensure Informed consent does not need to be re-consented and will 
consult the IRB.  
• Subjects will be called or have an office visit,  
o Has undergone index procedure on the operative knee with NitrX and 
o In the 20K001 study and 
o Would be willing to complete a KOOS Jr survey 
• Once the survey/questionnaire is completed, the site will compile the data 
parameters into a data collection form provided by the MPO and send it to the 
MPO upon completion for analysis.  
 
Data Parameters 
The data parameters listed below will be collected anonymized before being provided to 
MPO.  
 
De-Identified Subject # 
• A minimum of 100 subjects with Evolution NitrX will be assigned a de-identified 
subject number entered into the case report form.  
Data Collection and Follow-up Schedule 
Data Collection 
3 years 
5 years 
7 years 
10 years 
KOOS Jr 
X 
X 
X 
X 
SAE including Revision 
X 
X 
X 
X 
 

 
 
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Postoperatively 
• Subject Status 
o Is the subject deceased? 
o Date the subject was deceased. 
• Is the subject revised? 
o Reasons for revision  
o If a revision occurs, the removed and retained components will be provided. 
o Date that the revision occurred. 
• Adverse events  
o Information regarding adverse events that have occurred after surgery will 
be provided.  
SCOPE 
Table 1. Evolution NitrX Scope 
Part Number  
Product Name  
Femoral Components  
EFSAN1PL  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 1 LEFT  
EFSAN2PL  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 2 LEFT  
EFSAN3PL  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 3 LEFT  
EFSAN4PL  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 4 LEFT  
EFSAN5PL  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 5 LEFT  
EFSAN6PL  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 6 LEFT  
EFSAN7PL  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 7 LEFT  
EFSAN8PL  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 8 LEFT  
EFSAN1PR  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 1 RIGHT  
EFSAN2PR  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 2 RIGHT  
EFSAN3PR  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 3 RIGHT  
EFSAN4PR  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 4 RIGHT  
EFSAN5PR  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 5 RIGHT  
EFSAN6PR  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 6 RIGHT  
EFSAN7PR  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 7 RIGHT  
EFSAN8PR  
EVOLUTION NitrX FEM CS/CR NONPOR TiNbN COATED SZ 8 RIGHT  
Tibial Bases  
ETAKN1SL  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 1 STD LEFT  
ETAKN2SL  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 2 STD LEFT  
ETAKN3SL  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 3 STD LEFT  
ETAKN4SL  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 4 STD LEFT  
ETAKN5SL  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 5 STD LEFT  
ETAKN6SL  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 6 STD LEFT  
ETAKN7SL  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 7 STD LEFT  
ETAKN8SL  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 8 STD LEFT  
ETAKN1SR  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 1 STD RIGHT  
ETAKN2SR  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 2 STD RIGHT  
ETAKN3SR  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 3 STD RIGHT  
ETAKN4SR  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 4 STD RIGHT  
ETAKN5SR  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 5 STD RIGHT  
ETAKN6SR  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 6 STD RIGHT  

 
 
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ETAKN7SR  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 7 STD RIGHT  
ETAKN8SR  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 8 STD RIGHT  
ETAKN2PL  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 2 PLUS LEFT  
ETAKN6PL  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 6 PLUS LEFT  
ETAKN8PL  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 8 PLUS LEFT  
ETAKN2PR  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 2 PLUS RIGHT  
ETAKN6PR  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 6 PLUS RIGHT  
ETAKN8PR  
EVOLUTION NitrX TIB KEELED NONPOR TiNbN COATED SZ 8 PLUS RIGHT