A prospective, single arm, multi-centre, observational, real world, post marketing surveillance to evaluate implant survivorship and performance of the Freedom® Total Knee System in total knee arthroplasty.
Trial Acronym
Freedom® 400
Secondary IDs if Any
Secondary ID
Identifier
MLSIPL/ Freedom® 400/V 1.0.0
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Hemant Wakankar
Designation
Chief Investigator
Affiliation
Deenanath Mangeshkar Hospital and Research Center
Address
Deenanath Mangeshkar Hospital and Research Center, Near Mhatre Bridge, Erandawne, Pune, Maharashtra 411004
Pune MAHARASHTRA 411004 India
Phone
09921131122
Fax
Email
hwakankar@gmail.com
Details of Contact Person Scientific Query
Name
Dr Hemant Wakankar
Designation
Chief Investigator
Affiliation
Deenanath Mangeshkar Hospital and Research Center
Address
Deenanath Mangeshkar Hospital and Research Center, Near Mhatre Bridge, Erandawne, Pune, Maharashtra 411004
Pune MAHARASHTRA 411004 India
Phone
09921131122
Fax
Email
hwakankar@gmail.com
Details of Contact Person Public Query
Name
Dr Ashok Thakkar
Designation
Head of Clinical Research
Affiliation
Meril Life Sciences Pvt. Ltd.
Address
Meril Life Sciences Pvt. Ltd.
Survey No.135/139,
Bilakhia House,
Muktanand Marg,
Chala,
Vapi – 396 191,
Gujarat-India
Valsad GUJARAT 396191 India
Phone
912603063880
Fax
Email
ashok.thakkar@merillife.com
Source of Monetary or Material Support
Meril Life Sciences India Pvt. Ltd.
Bilakhia House, Survey No. 135/139,
Muktanand Marg, Chala Vapi – 396191,
Gujarat, India
Primary Sponsor
Name
Meril Life Sciences India Pvt Ltd
Address
Meril Life Sciences India Pvt. Ltd. Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi – 396191, Gujarat, India
Room no. 5038,
All India Institute Of Medical Sciences, Ansari Nagar, New Delhi - 110029 New Delhi DELHI
9868479933
csyadavortho@gmail.com
Dr Avtar Singh
Amandeep Hospital
Ground Floor, Education and Research Department, Amandeep Hospital
G.T. Road, Model Town, Amritsar, Punjab 143001
Amritsar PUNJAB
9876150258
avtarortho2002@gmail.com
Dr B D Chatterjee
Apollo Gleneagles Hospitals
9th floor, Clinical Trial Department
Apollo Gleneagles Hospitals,
58, Canal Circular Road, Kadapara, Kolkata, West Bengal 700054
Kolkata WEST BENGAL
9831516279
kanta_chatterjee@yahoo.com
Dr Sunil Rajan
Apollo Hospital
Orthopedics Department, Apollo Hospital, Scheme No. 74 C, Sector D, Vijay Nagar, Indore-452010, Madhya Pradesh, India Indore MADHYA PRADESH
9827023412
Drsunil_rajan@yahoo.co.in
Dr Subhash Jangid
Artemis Health Institute
Orthopedic Department, Artemis Health Institute, Sector 51, Gurgaon, Haryana 122018 Gurgaon HARYANA
9873705242
subhashjangid@yahoo.com
Dr Shailendra Patil
Curae Hospital
Orthopedics Department, Curae Hospital, Rosa Vista Apartment, Ghodbandar Road, Opposite Suraj Water Park, Thane West, Thane 400607, India Thane MAHARASHTRA
9320620978
shailendra_patil@yahoo.com
Dr Hemant Wakankar
Deenanath Mangeshkar Hospital and Research Center
Orthopedics Department,
Deenanath Mangeshkar Hospital and Research Center, Near Mhatre Bridge, Erandawne, Pune, Maharashtra 411004 Pune MAHARASHTRA
Orthopedics Department, Indraprastha Apollo Hospital, Sarita Vihar, Delhi Mathura Road, New Delhi 110076, India New Delhi DELHI
9810123331
raju.vaishya@gmail.com
Dr Bharat Jivani
Jivani Orthopaedic, Arthroscopy and Joint Replacement Centre
Jivani Orthopaedic, Arthroscopy and Joint Replacement Centre, 104, Ayush Doctor House, Behind Param Doctor house, Station Lal Darwaja Road, Surat 395003, Gujarat, India Surat GUJARAT
9638077767
drbharatjivani@gmail.com
Dr Jacob Varghese
Lakeshore Hospital and Research Centre Ltd.
Ground Floor, Orthopaedics Department, Lakeshore Hospital and Research Centre Ltd., N.H. -47 Bypass, Marud, Nettor, P.O. Kochi – 682042 Ernakulam KERALA
9847577660
varjac@gmail.com
Dr K Sudhir Reddy
Landmark Hospital
Orthopedics Department, Landmark Hospital, MCK Block 2, Near JNTU Metro Station,Opp.Vasantha Nagar Arch, Hyder Nagar, CBCID Colony Main Rd, Kukatpally, Hyderabad-500085, Telangana, India Hyderabad ANDHRA PRADESH
8111998020
ksudhirreddy@gmail.com
Dr Harish Bhende
Laud Clinic
Orthopedics Department, Laud Clinic, 180, Saraswati Nilayam, Hindu Colony, Dadar(East), Mumbai 400014, Maharashtra, India Mumbai MAHARASHTRA
91-22-24143169
harishbhende@gmail.com
Dr Kalpit Patel
Naisarg Knee and Hip Clinic
Orthopedics Department, Naisarg Knee and Hip Clinic, Knee and hip clinic 15, Shriniketan Society, 2nd Floor, Nxt to, Jetalpur Bridge, Sayajiganj, Vadodara 390005, Gujarat, India
Vadodara GUJARAT
Block V, Mondeal Business Park, Nr. Gurudwara, S.G. Highway, Thaltej, Ahmedabad 380054, Gujarat, India. Ahmadabad GUJARAT
9974087245
drjitendra001@gmail.com
Dr Vivek Logani
Paras Hospital
Block C1, Orthopaedic Department, Paras Hospital, Gurgaon
Sushant Lok- 1 Sector-43 Phase- I
Gurgaon, Haryana 122002 (India)
Gurgaon HARYANA
9871302712
viveklogani@gmail.com
Dr Santosh Kumar
Poorva International Orthopaedic Foundation
P-902,Lake town,Block-A,ground floor,Near
YES Bank,West Bengal,Kolkata Kolkata WEST BENGAL
9831911584
Santdr@gmail.com
Dr Haresh Bhalodiya
Saviour Multispeciality Hospital
Research Department, 3rd floor, Near Bharat Petrol Pump, Near Lakhudi Talav, Sadium Road, Navrangpura, Ahmedabad- 380014
Ahmadabad
GUJARAT Ahmadabad GUJARAT
9978985777
walk_fit@yahoo.com
Dr Sadik Shaikh
Unity hospital
Orthopedics Department, Ground floor, plot N. N/4, Janki park housing society, Aai mata road, Parvat patiya, Surat- 395010, Gujarat, India Surat GUJARAT
9825681012
drshaikhsadik@gmail.com
Dr Vrajesh Shah
Viroc Super Speciality Hospital
Orthopedic OPD
Aryakanya Vidyalaya Road Opposite Lohana Seva Mandal Hall
Nivrutti Colony
Karelibaug
Vadodara Vadodara GUJARAT
9427058959
drvrspi@gmail.com
Dr Yogesh Chaudhari
Wockhardt Hospitals
Orthopedics Department, Wockhardt Hospitals, Wani House, Near Wadala Naka,Mumbai Agra Road, Nashik 422001, Maharashtra, India Nashik MAHARASHTRA
Saviour Hospital Ethics Committee Saviour Hospital, Stadium Road, Near Bharat Petrol Pump, Near Lakhudi Talaw, Navrangpura, Ahmedabad, Gujarat 380014
Approved
Artemis Health Sciences Institutional Ethics Committee, Artemis Health Institute, Sector-51, Gurgaon-122001, Haryana
Submittted/Under Review
Dhwani Institutional Ethics committee
Approved
Fortis Hospital Ethics Committee
Approved
Institutional Ethics Committee (IEC) Department of Research, 6th Floor C Wing, Deenanath Mangeshkar Hospital and Research Centre, Off. Karve Road, Erandawne, Pune 411004
Submittted/Under Review
Institutional Ethics Committee, Apollo Gleneagles Hospital, 58, Canal Circular Road, Kadapara, Kolkata, West Bengal 700054
Approved
Institutional Ethics Committee, Fortis Hospital situated at Mundian kurd, Ludhiana-141015 Punjab, India
Approved
Institutional Ethics Committee, Paras Hospital C-I, Sushant Lok, Phase- I, Sector-43 Gurgaon 122002, Haryana- India
Approved
Institutional Ethics Committee, Indraprastha Apollo Hospitals, New Delhi, India
Approved
Lakeshore Ethics Committee, Lakeshore Hospital and Research Centre Ltd., N.H. -47 Bypass, Marud, Nettor, P.O. Kochi – 682042
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Freedom® Total Knee System
Freedom® Total Knee System in Total Knee Arthroplasty
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Subject is male or non-pregnant female
aged 18 years or older at the time of
study.
2. Subject is willing and able to provide
written Informed Consent by signing and
dating the IRB or EC approved Informed
Consent Form.
3. Subject is a candidate for a total knee
arthroplasty
4. Subject is willing and able to comply
with postoperative scheduled clinical and
radiographic evaluations
ExclusionCriteria
Details
1. Subject with a BMI greater than or equal
to 40
2. Subject with an active infection within
the affected knee joint
3. Subject with neuromuscular or
neurosensory deficiency that may limit
ability of the patient to evaluate the
safety and efficacy of the device
4. Subject with a known sensitivity to
device materials
5. Subject is unwilling or unable to sign
the Informed Consent Document.
6. Subject with short Life expectancy less
than 5 years (e.g. Cancer, HIV/AIDS)
7. Subject with history of deep vein
thrombosis or other thrombotic disorders.
8. Subject with conditions such as
Parkinsonism, loco motors ataxia, spinal
scoliosis or kyphosis, stroke etc. that
would affect their loco motors stability
and interfere with assessment of Range of
Motion of the target Knee.
9. Subject who, in consideration of treating
doctor, would not be suitable for
compliance of the follow up
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1. Implant Survivorship
2. Cumulative Revision
Rate
6 weeks, 6 months, 1 year, 3 years, 5 years , 7 years and 10 years
Secondary Outcome
Outcome
TimePoints
1. Knee Society Score
2. WOMAC (Western Ontario
and McMaster
Universities
Osteoarthritis) Pain
3. Range of Motion
4. SF-36 Questionnaire
Short Form Health
Survey questionnaire)
5. Radio graphic Analysis
6. Adverse Events
Pre-Op, 6 weeks, 6 months, 1year, 3, 5, 7 and 10 years
Target Sample Size
Total Sample Size="400" Sample Size from India="400" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
This is prospective, single arm, multi-centre, observational, real world, post marketing surveillance to evaluate implant survivorship and performance of the Freedom® Total Knee System in total knee arthroplasty in minimum 400 patients in India at minimum 15-20 centres.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Freedom® Total Knee System used in total knee arthroplasty at different time points [Time Frame: 6 weeks, 6 months, 1 year, 3 years, 5 years, 7 years and 10 years].
All eligibel subjects based on inclusion/exclusion will be approached to sign Informed Consent form approved by respective ethics committee before starting the study related process. Freedom® Total Knee System is indicated in subjects with Subjects suffering from severe knee joint pain, loss of mobility and disability due to rheumatoid arthritis, osteoarthritis, function deformities, post traumatic loss of knee joint contour.The subject will be kept on a standard regimen in post operative and follow-up period. Subject’s clinical follow-up will be taken at 6 weeks (± 15 days), 6 months (± 28 days), 1 year (± 1 month), 3 years (± 1 month), 5 years (± 1 month), 7 years (± 1 month), 10 years (± 1 month).