| CTRI Number |
CTRI/2024/04/066496 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MISSO Robotics System(Robot-assisted orthopedic surgeries are gaining popularity for their potential benefits, including improved accuracy, reproducibility, reduced pain, and faster recovery) |
|
Scientific Title of Study
|
MissoBOT-A prospective, single-arm, multi-center, post-marketing surveillance study to evaluate the safety
and efficacy of the MISSOâ„¢ ROBOTIC SYSTEM.
|
| Trial Acronym |
MISSO ROBOTIC SYSTEM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHCPL/MissoBOT, V1.0.0 dated 28-12-2023 |
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 |
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 |
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
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
Senior Manager- Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
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 |
|
|
Source of Monetary or Material Support
|
| Meril Heathcare 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 = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailendra Patil |
Aditi Hospital |
Alhad 185/R.Opp. Kalidas sports complex, Purushottam Kheraj Rd, Mulund West, Mumbai, Maharashtra 400080 India
Mumbai
MAHARASHTRA |
9320620978
shailendra_patil@yahoo.com |
| Dr Mohhammed Hasil M |
Asten Ortho Hospital |
NH 66, Opposite Thappys Arcade, Pantheerankave, Kozhikode, Kerala 673019
Kozhikode
KERALA |
9946777722
drhasil@gmail.com |
| Dr VijayamohanS |
Aster Medicity Hospital |
Kuttisahib Road, Cheranelloor, South chittoor, Kochi, Kerala 682027, India
Ernakulam
KERALA |
9447760119
drvijayamohan@gmail.com |
| Dr Anoop Jhurani |
Fortis Escorts Hospital |
59, Jawahar Lal Nehru Marg, Sector 5, Malviya Nagar, Jaipur, Rajasthan 302017 India
Jaipur
RAJASTHAN |
9928532456
anoop.jhurani@gmail.com |
| Dr Vividh Makwana |
Hira Mongi Navneet Hospital |
Valji Ladha Rd, near Kalidas Natya Gruh, Mulund West, Mumbai, Maharashtra 400080
Mumbai
MAHARASHTRA |
9819470803
vividhm@gmail.com |
| Dr Neeraj Adkar |
Sai Shree Hospital |
Orthopedics department, 1st floor, 1104/03 plot, SR. No. 157, CTS, 26, DP Rd, Aundh, Pune, Maharashtra 411007 India.
Pune
MAHARASHTRA |
9822051881
knee.expert@gmail.com |
| Dr Chandrasekhar P |
Sakra Hospital |
SY NO 52/2 & 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru, Karnataka 560103
Bangalore
KARNATAKA |
9741161567
shekarbones@yahoo.com |
| Dr Shekhar Srivastav |
Sant Parmanand Hospital |
Head of the Orthopedics department. 1st Floor, room number 105, Plot NO 1,2 & 3, Park Area Yamuna Bazar Sant Parmanand Hospital Ring Rd, Kashmere Gate, New Delhi, Delhi, 110006 India.
New Delhi
DELHI |
9818241028
drssrivastav@hotmail.com |
| Dr Sujoy kumar Bhattacharjee |
Sarvodaya Hospital & Research Centre |
Sector 8, Faridabad, Haryana 121006
Faridabad
HARYANA |
9999043722
drsujoy1972@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Good Society Ethical Research |
Approved |
| Institutional ethics committee Hira mongi navneet hospital |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.The subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form.
2.In the case of a subject and LAR being illiterate a literate impartial witness is required during consenting.
3.If the subject is not able to write on behalf of the subject the subjects LAR (Legally acceptable representative) can fill out the informed consent.
4.The subject is willing and able to comply with postoperative scheduled clinical evaluations.
5.Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
6.The inclusion criteria for the use of MISSO as a stereotaxic device for knee arthroplasty include surgeons seeking assistance in preoperative planning using patients medical diagnostic images and requiring orientation and reference information during intraoperative procedures.
7.Only the participating surgeons who oversee the utilization of surgical tools will execute the preoperative surgical plan while using MISSO as a stereotaxic device for knee arthroplasty.
8.The subject should have attained at least the adult age 18 years at the time of the surgery.
|
|
| ExclusionCriteria |
| Details |
1.Without informed consent, the subject is not eligible for the study
2. If the robotic system of any other brand is used, the subject shouldn’t be included in the study
3. Individuals with any active infections are excluded.
4. Individuals exhibiting skeletal immaturity are not considered.
5. Individuals who can be in situations wherein strong infrared sources or infrared reflectors are present in the vicinity of the trackers are
excluded.
6. Implants that are not compatible with the system are excluded.
7. Pregnant ladies shall be excluded from the study.
8. Subjects with a short life expectancy of fewer than 1 year
9. Subject with a known sensitivity to device materials
10. Subjects with neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the
device
11. Subjects with a history of deep vein thrombosis or other thrombotic disorders
12. Subjects with conditions such as severe Parkinsonism and locomotor ataxia that would affect their locomotor stability and interfere with the assessment of the Range of Motion of the target knee
13. Subjects with severe osteoporosis (T score greater than -3) shall be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Component Alignment - TKA
2. Component Alignment-TKA
3. Component Alignment - TKA
4. Bonecutaccuracy
5. Intra-Operative Complications
6. Post-resection Soft Tissue Release(STR)and reosteotomy
7. Accuracy of total knee arthroplasty component placement
8. Adverse Events |
1. Time Frame: Post-operative
(Day-0)
2. TimeFrame:3months
3. Time Frame: 3 weeks,3months ,6months, 1 year
4. Time Frame :Pre-Cut and Intraoperative measurements
5. Time Frame: Intra-operative
6. TimeFrame:Intra-operative
7. TimeFrame:PreoperativePlan,3weeks,3months,6months,
1 year
8. Time Frame: Postoperative, 3 weeks, 3months, 6months, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Radiographic assessment of Limb Alignment
2.Radiographic assessment of prosthesisposition
3.Radiographic assessment for MISSO ROBOTIC SYSTEM registration
4.Operative time
5.Alteration in the Hemoglobin Level
6.Percentage of Subjects with Postoperative Coronal Limb Alignment of more than 3 from the Planned Coronal Limb Alignment
7.Change in the objective Knee Society Score from the baseline
8.Severe & rare complications
9.Radiographic assessment
10.Adverse Events
11.Range of Motion
12.SF-12 Questionnaire
|
Time Frame: Pre-operative, Intra-operative,3 Weeks, 3 Months, 6 month & 1 Year |
|
|
Target Sample Size
|
Total Sample Size="71"
Sample Size from India="71"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
09/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
MissoBOT: A Prospective, Single-arm, Multi-Center, Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of the MISSO ROBOTIC SYSTEM.
Study Objectives: To Evaluate the Safety and Efficacy of the MISSO ROBOTIC SYSTEM has application throughout the MISSO and is intended for use as a stereotaxic device for knee arthroplasty.
Study Design: A Prospective, Single-arm, Multi-Center, Post-Marketing Surveillance Study.
Background: The surgeon uses a bone saw to remove the arthritically damaged areas at the bottom of the femur and the top of the tibia. Each bone is reshaped to fit its new prosthesis exactly. The procedure is performed manually by the orthopedic surgeons. The MISSO is intended for use as a stereotaxic device for knee arthroplasty. It is to assist a surgeon in planning pre-operation using medical diagnostic images obtained from the patient and to provide orientation and reference information during intra-operative procedures. The surgical tools, under the supervision of the surgeon, perform the pre-operative surgical plan. |