FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/097555 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 30/12/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   To study the safety and performance of interference screws in knee arthroscopy patients. 
Scientific Title of Study   A Prospective Post-Market Clinical Follow-up Study to Evaluate the Safety and Performance of Polyether Ether Ketone Carbon Fibre (PEEK CF) Interference Screws in Knee Arthroscopy Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CR_PMCF/P_27 Version 1.0 Dated 05.08.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohd Aslam 
Designation  Clinical Research Manager 
Affiliation  Auxein Medical Pvt Ltd 
Address  Plot No 168-169-170 Phase IV Sector 56 HSIIDC Industrial Estate Kundli

Sonipat
HARYANA
131028
India 
Phone  7419660141  
Fax    
Email  m.aslam@auxeinmedical.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohd Aslam 
Designation  Clinical Research Manager 
Affiliation  Auxein Medical Pvt Ltd 
Address  Plot No 168-169-170 Phase IV Sector 56 HSIIDC Industrial Estate Kundli

Sonipat
HARYANA
131028
India 
Phone  7419660141  
Fax    
Email  m.aslam@auxeinmedical.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohd Aslam 
Designation  Clinical Research Manager 
Affiliation  Auxein Medical Pvt Ltd 
Address  Plot No 168-169-170 Phase IV Sector 56 HSIIDC Industrial Estate Kundli

Sonipat
HARYANA
131028
India 
Phone  7419660141  
Fax    
Email  m.aslam@auxeinmedical.com  
 
Source of Monetary or Material Support  
Auxein Medical Pvt Ltd Plot No 168-169-170 Phase IV Sector 57 HSIIDC Industrial Estate Kundli Sonipat 131028 Haryana India  
 
Primary Sponsor  
Name  Auxein Medical Pvt Ltd 
Address  Plot No 168-169-170 Phase IV Sector 57 HSIIDC Industrial Estate Kundli Sonipat 131028 Haryana India  
Type of Sponsor  Other [Medical Device Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Asjad Mahmood  All India Institute of Medical Sciences  Room No. 410, 4th floor, Department of orthopaedics, Jai Prakash Narayan Apex Trauma Centre
South
DELHI 		 9968856990

Mahmoodasjad@gmail.com 
Dr Sumit Arora  Maulana Azad Medical College & LNJP Hospital  Room No-608, Department of Orthopedics, Orthopedic Block, New Delhi
Central
DELHI 		 9868329380

mamc_309@yahoo.co.in  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee All India Institute of Medical Sciences   Approved 
Institutional Ethics Committee Maulana Azad Medical College New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  None  NA 
Intervention  PEEK CF interference screws for ACL/PCL reconstruction  Study participants will be followed at 6 week 3 month 6 month and 12 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with confirmed ACL or PCL injury who are planned for ACL or PCL resonstruction through arthroscopy surgery. 
 
ExclusionCriteria 
Details  1. Patients with a disease entity or condition that could hinder healing and create unacceptable risk of fixation failure or complications such as known active cancer neuromuscular disorder etc.

2. Patients with inadequate tissue coverage of the operative site.

3. Patients with history of effected knee arthroscopy surgery at the same site.

4. Patients with history of metal allergies.

5. Patients with documented mental disorders.

6. Patients with life threatening conditions.

7. Patients who are incarcerated or have pending incarceration.

8. Patients with associated fractures which may interfere the rehabilitation and timely surgical fixation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Performance of PEEK CF interference screws will be assessed by improvement in KOOS and IKDC score from preoperative to post operative follow up visits   6 Week
3 Month
6 Month
12 Month
 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of safety of PEEK CF interference screws will be done by recording and analysis of complications and serious/adverse events at post operative visits.  6 Week
3 Month
6 Month
12 Month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/12/2025 
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="2"
Months="0"
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 multi-centric prospective PMCF study. The study aims to assess safety and performance of PEEK CF interference screws used in ACL and PCL reconstruction. A total of 40 patients will be enrolled in the study. Total duration of study is two years.  
Close