| CTRI Number |
CTRI/2025/10/096684 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on patients undergoing knee ligament or tendon repair using arthroscopic implants to assess safety and recovery outcomes. |
|
Scientific Title of Study
|
Arthroscopy Implants for Knee:A Prospective, Observational, Multi-centre, Single-arm, Open-label, Post-market Clinical Followup Study to Evaluate Safety and Performance of the Arthroscopy Implants for Knee in a RealWorld Setting. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MHCPL/Arthroscopy Implants for Knee V2.0.0 01-Jul-2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
AGM-Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near BilakhiaStadium,Surveyno 135,139,Muktanand marg, Chala, Vapi-396191
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
AGM-Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near BilakhiaStadium,Surveyno 135,139,Muktanand marg, Chala, Vapi-396191
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
AGM-Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near BilakhiaStadium,Surveyno 135,139,Muktanand marg, Chala, Vapi-396191
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 = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinay Tantuway |
Arthros Multispecialty Hospital, |
Ground Floor, Department of Orthopedics, 328/2/4/1 Dargah Bypass, Link Road, MR-9, Khajrana, Indore, Madhya Pradesh 452016
Indore
MADHYA PRADESH |
9893430089
vinayforever@gmail.com |
| Dr Achal Saradava |
HCG Hospital |
Department of Orthopedics , Near Aastha Avenue, 150 Feet Ring Road, Ayodhya Chowk, Rajkot, Gujarat 360006
Rajkot
GUJARAT |
9426449977
dr.achal.saradava@gmail.com |
| Dr Umesh Jadhav |
PanOrtho Hospital |
Department of Orthopedics, Plot no.F11, Sector number 26,Chhatrapati Sambhaji Maharaj Chowk,Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharastra 411044
Pune
MAHARASHTRA |
9822478288
umeshortho@gmail.com |
| Dr Chintan Vadi |
Restore Orthocare Hospital |
Department of
Arthroscopy & Sports Medicine Specialist, 5/6/7 Floor, Amruta Enclave, Mavdi Police Head Quarter Road, Near Suvarnabhoomi Heights, Speedwell Chowk, Rajkot, Gujarat, 360005, India
Rajkot
GUJARAT |
9879678767
chintanvadi@gmail.com |
| Dr Bhamare D S |
Sainath Hospital |
Sant Nagar, Pune - Nashik Hwy, Moshi Pradhikaran, Moshi, Pimpri-Chinchwad, Maharashtra 411070
Pune
MAHARASHTRA |
7507899338
drbhamareds@gmail.com |
| Dr Tejas Waghela |
Shree Narayan Hospital |
Department of Arthroscopy and Ortho opp. RLT College, New Radhakisan Plots, Civil LinesAkola, Akola, Maharashtra
Akola
MAHARASHTRA |
7666245498
drtejaswaghela@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
Approved |
| Central Independent Ethics Committee |
Approved |
| EC N M VIRANI WOCKHARDTHOSPITAL |
Approved |
| ETHICS COMMITTEE N M VIRANI WOCKHARDT HOSPITAL |
Approved |
| Lotus Superspeciality Hospital |
Approved |
| Rectitude 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. Arthroscopy Knee System implants are intended to be used in both men and non-pregnant women of age 18 years or above.
2. The Participants who are eligible for the arthroscopy system which is used in the surgical procedures related to knee ligament fracture fixation are included in the study.
3. The Participants who require connective tissue tendon repairs for the knees.
4. Participants who require the attachment of soft tissue grafts or bone-tendon grafts to the tibia and/or femur during cruciate ligament reconstruction surgeries and fixation of soft tissue.
5. The patient is willing and able to comply with postoperative scheduled clinical evaluations. |
|
| ExclusionCriteria |
| Details |
1.Systemic or acute or chronic infection at the surgical site.
2. Known allergy or sensitivity to product materials.
3. Insufficient tissue coverage in the surgical area.
4. Any medical or surgical condition that would preclude the potential benefit of the operation.
5. Fever or leukocytosis.
6. Long-term infection, pregnancy and nursing, radiation bone therapy, cardiovascular diseases, metabolic bone disease, renal diseases, and pediatric Participants should not be included in the study.
7. Participants within whom cooperation or mental
competence is lacking, thereby reducing Participants compliance.
8. The Participants, being considered for treatment by a doctor, would not comply with the follow-up schedule.
9. Participants who is unwilling or unsuitable for
postoperative instructions.
10. The Participants who is unwilling or unable to sign the Informed Consent Document will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Implant failure rate
2.Reoperation rate
3.Physical Function |
1.Time Frame: Intra-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years
2.Time Frame: 3 weeks, 3 months, 6 months, 1 year, 2 years
3.Time Frame: Pre-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Implant failure rate
2.Reoperation rate
3.Physical Function
4.Pain Score
5.Wound Complications
6. Intra-operative Complications
7.Length of Hospital Stay
8. SF-12 Questionnaire
9. Radiographic Analysis |
Timeframe- Pre Operative, Intra Operative, Discharge, Post Operative, 3 week, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |
|
|
Target Sample Size
|
Total Sample Size="107"
Sample Size from India="107"
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)
|
29/11/2025 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Study Name: A Prospective, Observational, Multi-centre, Single-arm, Openlabel, Post-market Clinical Follow-up Study to Evaluate Safety and Performance of the Arthroscopy Implants for Knee in a RealWorld Setting.
Short Title: Arthroscopy Implants for Knee
Objective: The study aims to evaluate the safety and performance of arthroscopy implants in participants undergoing knee surgeries.
Study Design: A Prospective, Observational, Multi-centre, Single-arm, Openlabel, Post-market Clinical Follow-up Study.
Rationale of the Study Arthroscopy implants have become essential tools in minimally invasive orthopedic procedures, particularly for treating conditions in the shoulder, elbow, and hand/wrist joints. These procedures allow for targeted interventions, offering participants faster recovery times, less post- operative pain, and improved mobility compared to traditional open surgeries. However, there remains a need to comprehensively assess the safety and performance of these implants in real- world settings, where participant populations may vary significantly from clinical trials. This study is designed to evaluate the safety and performance of arthroscopy implants in Participants undergoing knee surgeries |