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CTRI Number  CTRI/2026/04/108646 [Registered on: 20/04/2026] Trial Registered Prospectively
Last Modified On: 09/04/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational - PMS 
Study Design  Other 
Public Title of Study   Evaluating the Performance and Safety of the ACTIKNEE Knee Implant in Adult Patients Undergoing Total knee arthroplasty (TKA) Surgery. 
Scientific Title of Study   A Multicenter, Prospective, Observational study to Evaluate the Performance and Safety of the ACTIKNEE Knee Implant in Adult Patients Undergoing Total knee arthroplasty (TKA) Surgery. 
Trial Acronym  ACTIKNEE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arnab Karmakar  
Designation  Principal Investigator 
Affiliation  Consultant Orthopedic Surgeon 
Address  Kothari Medical Center Joint & Bone Care Hospital, 8/3 Alipore Road (Opposite to Alipore Zoo) Kolkata.

Kolkata
WEST BENGAL
700 027
India 
Phone  9830401377  
Fax    
Email  arnaborthoclinic@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kushal Sarda 
Designation  GM Medical Affairs 
Affiliation  Alkem Laboratories Ltd 
Address  Alkem Laboratories Ltd, Alkem House, Lower Parel, Mumbai-400013.

Mumbai
MAHARASHTRA
400013
India 
Phone  9890989871  
Fax    
Email  kushal.sarda@alkem.com  
 
Details of Contact Person
Public Query  
Name  Dr Achal Thul 
Designation  Manager - Clinical Research 
Affiliation  Alkem Laboratories Ltd 
Address  Alkem Laboratories Ltd, Alkem House, Lower Parel, Mumbai-400013.

Mumbai
MAHARASHTRA
400013
India 
Phone  9702397443  
Fax    
Email  achal.thul@alkem.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  ALKEM MEDTECH ORTHO PRIVATE LIMITED 
Address  Plot No G 1432, Tal-Lodhika, METODA, Rajkot, Gujarat (India)- 360021 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Singh  Anup Institute of Orthopedics & Rehabilitation (AIOR)  Anup Institute of Orthopedics & Rehabilitation (AIOR), G 75, 77, PC Colony Rd. Kankarbagh, Patna, Bihar- 800020, India.
Patna
BIHAR 		 8294240349

drashishsingh@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Anup Institute of Orthopaedics and Rehabilitation - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z966||Presence of orthopedic joint implants,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil- Observational Study  Nil- Observational Study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Adult participants aged 18 to 75 years, of any gender.
2. Participants with a confirmed diagnosis of symptomatic knee osteoarthritis requiring total knee arthroplasty (TKA).
3. Participants who are eligible to undergo TKA using the ACTIKNEE knee implant in conjunction with high-quality bone cement, as determined at the investigator discretion and in accordance with standard surgical practice.
4. Written informed consent obtained from each participant prior to study enrollment.
5. Willing and able to comply with all study procedures, protocol requirements, and scheduled follow-up visits. 
 
ExclusionCriteria 
Details  1. Patients with a history of prior knee arthroplasty or revision surgery in the target knee.
2. Patients with an active knee joint infection or a history of infection in the target knee within the past 12 months.
3. Patients with severe bone loss, bone deformity, or other structural abnormalities that would preclude proper implant placement, as determined by the investigator.
4. Patients with a history of systemic infection, immunodeficiency, or any other illness that significantly limits mobility or could interfere with postoperative recovery.
5. Patients with a known allergy or hypersensitivity to any component of the ACTIKNEE knee implant or bone cement.
6. Patients with significant uncontrolled comorbidities (e.g., poorly controlled diabetes mellitus, unstable cardiovascular disease, or other severe systemic illness) that, in the opinion of the investigator, could adversely affect surgical outcomes or compliance with follow-up.
7. Any patient who, in the opinion of the investigator, is not considered suitable for the study due to medical, psychological, or social reasons that may compromise safety, compliance, or study outcomes. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate the performance of the ACTIKNEE knee implant
in terms of functional improvement and patient-reported outcomes following total knee arthroplasty.
• To evaluate the safety profile of the ACTIKNEE knee implant.
• To evaluate the effectiveness of the ACTIKNEE knee implant
in providing pain relief following total knee arthroplasty. 		 Primary Performance Endpoint:
1. Mean change from baseline in Knee Society Score (KSS) – Knee Score at 6 months post-operative 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a prospective Observational multicenter post marketing surveillance study. Adult patients with a diagnosis of symptomatic knee osteoarthritis requiring total knee arthroplasty who are eligible to undergo TKA using the ACTIKNEE knee implant in conjunction with high quality bone cement as per standard surgical practice will be screened based on the study inclusion and exclusion criteria. 
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