| CTRI Number |
CTRI/2024/10/075646 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Opulent Uni Knee system is a type of medical device used in knee replacement surgery |
|
Scientific Title of Study
|
A prospective, single-arm, multi-centre, observational study to evaluate the safety and
performance of Opulentâ„¢ Knee System (Uni Knee) in patients who underwent Uni Knee Replacement
in the real-world setting. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHCPL/ Opt Uni Knee V1.0.0 dated 22 Dec 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
Senior Manager- Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Product Performance and Engineering Department, Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand
marg, Chala, Vapi-396191, Gujarat, India
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
Senior Manager- Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Product Performance and Engineering Department, Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand
marg, Chala, Vapi-396191, Gujarat, India
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
Senior Manager- Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Product Performance and Engineering Department, Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand
marg, Chala, Vapi-396191, Gujarat, India
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Healthcare Pvt. Ltd.
Meril Park, H1-H3,
Survey No. 1575 and 1088,
Muktanand Marg. Chala, Vapi,
Valsad, Gujarat, 396191 |
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Pvt Ltd |
| Address |
Near Bilakhia Stadium, Survey no 135/139,Muktanand marg, Chala,
Vapi-396191, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailendra patil |
Aditi Hospital |
185/R, Opp Kalidas Sports complex, P.K Road,Mulund, Mumbai 400080
Mumbai
MAHARASHTRA |
9320620978
shailendra_patil@yahoo.com |
| Dr Tarandeep Singh Gill |
Healing Hospital |
Orthopedics department, 16-17-18, 19-20-21-22, Piccadily Rd, Sub.city Canter, Sector 34A, Sector 35, Chandigarh, 160022
Chandigarh
CHANDIGARH |
9779247973
drtarangill@gmail.com |
| Dr Niraj Kasat |
Neel Orthopedic Super Speciality Hospital |
1st floor, sheetal Niketan Co-operative housing society, Bhayander, Mumbai 401105
Mumbai
MAHARASHTRA |
9820962685
neerajkasat@yahoo.com |
| Dr Pritam Agarwal |
Shree Narayan Hospital |
Near Ganj Mandi Raod, behind Sector 5, Devendra nagar. Pandri, Raipur 492001, Chhattisgarh
Raipur
CHHATTISGARH |
8826840020
agrawalpritam@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Adroit Ethics Committee |
Approved |
| Adroit Ethics Committee |
Approved |
| Indus International hospital |
Approved |
| SMC Heart Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. The Subject is a male or non-pregnant female aged 18 years or older at the time of study.
2. The Subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent Form in the presence of an impartial witness.
3. The Subject is eligible for a partial arthroplasty only.
4. The Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
5. The Subject has non-inflammatory degenerative joint disease, including osteoarthritis, traumatic arthritis, or avascular necrosis.
6. The Subject has an inflammatory degenerative joint disease, excluding severe rheumatoid arthritis.
The Subject has functional deformities such as varus, valgus, or flexion deformities.
8. The Subject has fractures that are unmanageable using other techniques.
9. The Subject has a correction of functional deformities. |
|
| ExclusionCriteria |
| Details |
1. The Subject with a BMI greater than or equal to 40.
2. Subjects with a known sensitivity to device materials.
3. The Subject is unwilling or unable to sign the Informed Consent
Document.
4. The Subject has a history of infection in the affected joint that may affect the function of the implanted prosthetic.
5. Subjects with less-than-optimal bone stock on femoral or tibial surfaces resulting from a history of disease, infection, or prior surgical procedures non-conducive towards adequate support for the implantation.
6. Any Subject has compromised skeletal bone quality.
7. Any Subject has neuropathic disease that adversely affects the prosthetic joint.
Any Subject has osteoporosis or a deficiency of musculature that
compromises the affected limb.
9. Any Subject with pain-free and stable arthrodesis in an adequate functional position.
10. Any Subject with unstable knee joint secondary to negative collateral ligament integrity.
11. Any Subject, being considered for treatment by a doctor, would not comply with the follow-up schedule.
12. Subjects with rheumatoid arthritis shall be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Range of Motion
2.Implant Survivorship
3. Cumulative Revision Rate
4. Intra-operative complications |
1. Time Frame: Pre-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years
2. Discharge, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years
3. Time Frame: 3 weeks, 3
months, 6 months, 1 year, 2
years, 3 years, 5 years
4. Time Frame: During
procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Knee Society Score
2. Oxford Knee Score
3. Pain
4. Technical Difficulties Encountered During Device
Implantation
5. Postoperative complications
6. Type of Procedure
7. Subsequent requirement TKR
8. Length of hospital stay
9. SF-12 Questionnaire
10. Radiographic Analysis
11. Adverse Events
12. Metallosis |
Time Frame: Pre-operative, Postoperative, Discharge, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years and 5 years |
|
|
Target Sample Size
|
Total Sample Size="194"
Sample Size from India="194"
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)
|
15/11/2024 |
| 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="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
OpT Uni Knee: A prospective, single-arm, multi-centre, observational study to evaluate the safety and performance of Opulentâ„¢ Knee System (Uni Knee) in patients who underwent Uni Knee Replacement in the real-world setting.
Device Used: Opulentâ„¢ Knee System (Uni Knee) Objectives: The objective of the study is to evaluate the safety and performance of the Opulentâ„¢ Knee System (Uni Knee) in patients who underwent Uni Knee Replacement in a real-world setting.
Study Design: A prospective, single-arm, multi-centre, observational study, realworld, post-marketing surveillance.
Rationale of the Study: The study design is a prospective, single-arm, multi-centre, observational study, post-marketing surveillance of the commercially available Opulent™ Knee System (Uni Knee). The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical and radiographic evaluations prior to their Uni Knee arthroplasty. The postoperative clinical and radiographic evaluations will be conducted at 3 weeks ± 3 days, 3 months ± 15 days, 6 months ± 15 days, 1 year ± 30 days, 2 years ± 30 days, 3 years ± 30 days, 5 years ± 30 days. The primary objective of this study is to obtain implant/component survivorship and clinical outcomes data for commercially available Opulent™ Knee System (Uni Knee) used in Uni Knee arthroplasty. (The assessment will include implant survivorship and clinical performance by pain and function, Range of motion, quality of life data, radiographic parameters, and survivorship). |