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CTRI Number  CTRI/2025/06/088092 [Registered on: 02/06/2025] Trial Registered Prospectively
Last Modified On: 22/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Safety and Effectiveness of a Novel Robotic Total Knee Arthroplasty (TKA) System 
Scientific Title of Study   A Prospective, Multicenter, Single-arm, Interventional OUS Study to Demonstrate the Safety and Effectiveness of the mBos TKA System 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
PRO-00183 Revision 03 dated 30-09-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Taufiq Panjwani 
Designation  Senior Consultant 
Affiliation  Krishna Shalby Multispecialty Hospital 
Address  Krishna Shalby Multispecialty Hospital, 319-Green City, Ghuma, Via Bopal, Ahmedabad, Gujarat, 380058 India

Ahmadabad
GUJARAT
380058
India 
Phone  9820616512  
Fax    
Email  arthroplasty18.sg@shalby.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachin Kagane 
Designation  Medical Monitor 
Affiliation  Reliance Life Sciences Pvt. Ltd. (RLS) 
Address  Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre (DALC)R-282, TTC Area ofMIDC, Thane - Belapur Road, Rabale, Navi Mumba Thane MAHARASHTRA 400701 India

Mumbai
MAHARASHTRA
400701
India 
Phone  9987885679  
Fax    
Email  Sachin1.Kagane@relbio.com  
 
Details of Contact Person
Public Query  
Name  Vinay Onkar 
Designation  Project Manager 
Affiliation  Reliance Life Sciences Pvt. Ltd. (RLS) 
Address  Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre (DALC)R-282, TTC Area ofMIDC, Thane - Belapur Road, Rabale, Navi Mumba Thane MAHARASHTRA 400701 India

Mumbai
MAHARASHTRA
400701
India 
Phone  8169460662  
Fax    
Email  Vinay.Onkar@relbio.com  
 
Source of Monetary or Material Support  
Monogram Orthopaedics Inc 3913 Todd Lane, Suite 307 Austin, TX 78744, USA  
 
Primary Sponsor  
Name  Monogram Orthopaedics Inc. 
Address  3913 Todd Lane, Suite 307 Austin, TX 78744, USA 
Type of Sponsor  Other [Medical Equipment Manufacturing Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Taufiq Panjwani  Krishna Shalby Multispecialty Hospital  319-Green City, Ghuma, Via Bopal, Ahmedabad, Gujarat, 380058 India
Ahmadabad
GUJARAT 		 9820616512

arthroplasty18.sg@shalby.in 
Dr Manish Saini  Shalby Hospitals  Nr. Navyug College, Rander Rd, Adajan, Surat, Gujarat, 395009 India
Surat
GUJARAT 		 8743954552

orthopedic2.surat@shalby.in 
Dr Deepak Saini  Shalby Multispecialty Hospital  Under Pass, Delhi - Ajmer Expressway, 200 Feet Bypass Rd, near Gandhi Path, Chitrakoot Sector 3, Vaishali Nagar, Jaipur, Rajasthan 302021, India
Jaipur
RAJASTHAN 		 9824012492

deepak.saini@shalby.org 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Commitee-Shalby Limited  Approved 
ETHICS COMMITTEE SHALBY LIMITED  Approved 
Ethics Committee shalby limited  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  mBos TKA System  The mBôs TKA system is indicated for use in procedures where stereotactic surgery is suitable and where bony patient anatomy can be registered to a CT-based three-dimensional anatomical model such as TKA (Duration: Each eligible patient will undergo a knee replacement surgery using mBos robotic system and this will be a one-time procedure (avg surgery duration is 90-120 minutes). Post-surgery, each of these patients will be followed up for 12 weeks as per protocol.) 
Comparator Agent  none  none 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Subjects who are at least 21 years of age, verified by a
government-issued identification card/document.
2. Subjects who are skeletally mature, as evidenced
radiographically by closed epiphyses.
3. Subjects identified needing unilateral TKA as the primary
surgical management of osteoarthritis, and post-traumatic
arthritis, defined radiographically by a Kellgren-Lawrence
Grade of 3 or higher.
4. Subjects who are, in the opinion of the Investigators and
approved study staff, able to understand and comply with
this Investigation and its procedures, including being
physically present for the required postoperative follow-up
procedures.
5. Female subjects of childbearing potential must test
negative for pregnancy at the time of screening.
6.All screened subjects, capable of fathering or bearing
children, must agree to use adequate birth control
measures (e.g., abstinence, oral contraceptives,
intrauterine device, barrier method with spermicide,
surgical sterilization) during the study and for 6 months after surgery
7.Menopausal females must have experienced their last
period more than 12 months prior to screening to be
classified as not of childbearing potential.
8. Subjects who are able to give voluntary, written informed
consent to participate in the study and from whom consent
has been obtained  
 
ExclusionCriteria 
Details  Candidates will be excluded if they meet any of the following criteria:
1. Subjects who have undergone previous open knee surgery in the operative knee without the mBos robotic system.
2. Subjects whose anatomy is inappropriate for the available range of primary TKA implant
3. Subjects who have a coronal deformity greater than 15° or a sagittal recurvatum greater than
10°, assessed radiographically
sizes.
4. Subjects who need a bilateral TKA, where the second TKA is needed within 120 days from
the first TKA
5. . Subjects who have an active systemic infection or an active local infection in or near the operative knee joint or have a previous history of joint infection.
6. Subjects who have a pathological skeletal condition or skeletal immaturity which would
significantly compromise the ability of the bone to withstand the stress required for
preparation of the bones and proper implantation of the prostheses.
7. Subjects who have known femoral or tibial bone stock of poor quality or inadequate to
provide stability for femoral or tibial fixation.
8. Subjects who have any type of metallic implant in the operative leg.
9. Subjects who have a known or suspected sensitivity to the metals or alloys or any other
materials in the investigational device or implant components (i.e. cobalt, chromium,
titanium, stainless steel, titanium nitride, aluminum, ultra-high molecular weight
polyethylene, PVC plastic).
10. Subjects who have a systemic illness or a neuromuscular, neurosensory, or musculoskeletal
deficiency that would render the patient unable to perform appropriate postoperative
rehabilitation or create an unacceptable risk of prosthesis instability or fixation failure.
11. Subjects who have significant comorbidities or conditions associated with high risk for
surgical or anesthetic survival.
12. Subject has any ongoing or history of underlying metabolic, hematologic, renal, hepatic,
pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal condition, which in
the opinion of the investigator places the subject at unacceptable risk
13. Subjects with uncontrolled diabetes
14. Subjects who have a previous history of knee joint infection.
15. Subjects who are pregnant or intend to become pregnant during the study.
16. Subjects who have previously experienced a stroke.
17. Subjects participating concurrently in another clinical trial or have participated in a clinical
trial within the last 90 days (about 3 months), or intend to during the course of the study.
18. Subjects who have a medical or psychiatric condition which, in the opinion of the
investigator, poses a risk of the patient being unable to complete the study or presents risks
associated with study participation.
19. Subjects who are known to be drug or alcohol abusers or with psychological disorders that
could affect follow-up care or treatment outcomes. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To demonstrate the safety of the mBos TKA System  Composite safety endpoint that includes four soft-tissue
complications identified in a literature search and reported below:
1) Neural Deficit (0.53%, Park et al.1
)
2) Vascular Injury (0.17% Butt et al.,2
)
3) Medial Collateral Ligament Injury (2.2%, Lee et al. 3
)
4) Extensor Mechanism Disruption (2.5%, Boyd et al.4
)
The percentage of knees experiencing the composite safety event
in this clinical trial will be compared to the sum 5.4% reported in
literature. 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate the effectiveness of the mBos TKA System   Postoperative coronal and axial knee implant component and limb Comparison of the 42 days (± 14 days) or at 6 weeks (± 2 weeks) postoperative axial component alignment to the planned alignment.
Comparison of the 42 days (± 14 days) or at 6 weeks (± 2
weeks) postoperative coronal limb alignment to the
planned limb alignment
alignment relative to the planned alignments, respectively, using
postoperative long-standing AP X-rays and CT scans at Week 6.  
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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   N/A 
Date of First Enrollment (India)   10/06/2025 
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)  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   The mBos TKA system is a stereotactic planning and implementation device intended to assist surgeons with primary total knee arthroplasty (TKA). It is an alternative to manual TKA template planning and bone preparation for TKA surgeries. This system aids surgeons with virtual implant placement, determining the relative position and orientation of anatomical structures and bone preparation. The mBos TKA System has been extensively evaluated in simulated clinical use conditions with all intended users (surgeons, sterile hospital staff, robot operators etc.). In this proposed clinical study, the Sponsor and Principal Investigators wish to confirm the clinical safety and effectiveness of the mBos TKA System in a representative patient population that would also qualify for traditional TKA surgery.  The primary objective of this study is to demonstrate that the mBos System is safe for use as an alternative to manual planning and sawing/cutting techniques, specifically in relation TKA soft tissue complications. This clinical investigation will be conducted as a prospective, non-randomized, multicenter study. This study design has been previously adopted in comparable clinical trials performed to achieve US market approval for similar devices for TKA applications namely “Robotic Arm Assisted Total Knee Arthroplasty”, (NCT02058069, ClinicalTrials.gov, 2016; Sponsor: MAKO, Stryker, USA); “TSolution One® Total Knee Arthroplasty”, (NCT03017261, Clinicaltrials.gov, 2020; Sponsor: Think Surgical, USA); and Stulberg et. al34. Investigators will recruit patients from their practice who require unilateral total knee arthroplasty. 
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