| CTRI Number |
CTRI/2025/05/087887 [Registered on: 29/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
MonoMod stem revision or complex primary total hip arthroplasty |
Scientific Title of Study
Modification(s)
|
A prospective, single-arm, multi-centre, observational, PostMarketing Clinical Follow-up Study to evaluate the safety and performance of MonoMod stem during revision or complex primary total hip arthroplasty in the real-world setting |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MHCPL/ MonoMod stem revision V2.0.0 dated 03-Jul-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near BilakhiaStadium,Survey no 135,139,Muktanand marg, Chala, Vapi
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near BilakhiaStadium,Survey no 135,139,Muktanand marg, Chala, Vapi
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near BilakhiaStadium,Survey no 135,139,Muktanand marg, Chala, Vapi
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, India. |
|
|
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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailendra Patil |
Aditi Hospital |
1st Floor, Orthopedic department, 185/R, Opp, Kalidas Sports Complex, P.K.Road,Mulund(West), Mumbai 400080
Mumbai
MAHARASHTRA |
9320620978
shailendra_patil@yahoo.com |
| Dr Akhil Arora |
MediSquare Hospital |
9, Vishnupuri, Bhanwarkua Square, AB Rd, Vishnupuri, Indore, Madhya Pradesh 452001
Indore
MADHYA PRADESH |
7223852796
aroraakhil2325@outlook.com |
| Dr Divyanshu S N Goyal |
SNG Hospital |
Navkar - II Apartment, Banwari Lal Jaju Marg, near Jain Temple, South Tukoganj, Indore, Madhya Pradesh 452001
Indore
MADHYA PRADESH |
9826060933
goyaldivyanshu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Adroit Ethics Committee |
Approved |
| Rectitude ethics Committee |
Approved |
| Rectitude ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M165||Unilateral post-traumatic osteoarthritis of hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants who undergo revision or complex primary total hip arthroplasty using the MonoMod femoral stem
2.Participant of age 18 and above, irrespective of the gender.
3. The Participant 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.
4. Participant is willing and able to comply with post-operative scheduled clinical and radiographic evaluations. |
|
| ExclusionCriteria |
| Details |
1.Participant with a known sensitivity to device materials.
2. Participant is unwilling or unable to sign the Informed Consent Document.
3. Participant being considered for treatment by a doctor would not comply with the follow-up schedule.
4. Pregnant and breastfeeding women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1.Revision Rate |
1.Time frame: 6 Week, 6 months, 1 year, 2 years, 5 years, 10 years |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Range of Motion
2.Harris hip scores
3.Radiographic assessments
4.Infection assessment
5.Intraoperative Complication
6.Discrepancy Measurement
7.SF-12 Questionnaire
8.Adverse Events
|
1.Time Frame: Pre-operative, 6 Weeks, 6 months, 1 year, 2 years, 5 years, 10 years
|
|
|
Target Sample Size
|
Total Sample Size="197"
Sample Size from India="197"
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)
|
30/05/2026 |
| 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="10"
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
Modification(s)
|
Title: MonoMod stem revision hip replacement system: A prospective, single-arm, multi-centre, observational, Post-Marketing Clinical Follow-up Study to evaluate the safety and performance of MonoMod stem during revision or complex primary total hip arthroplasty in the real-world setting
Short Title: MonoMod Stem Revision Hip Replacement System
Study population: The MonoMod stem during revision or complex primary total hip arthroplasty system is intended for use in total hip arthroplasty and hemi-hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components..
Objectives: The objective of this study is to assess the safety and performance of the MonoMod stem in patients who have undergone revision or complex primary total hip arthroplasty system.
Study Design: A prospective, single-arm, multi-centre, observational, real-world, Post-Marketing Clinical Follow-up Study
Rationale of the Study: Modern primary THA is among the most successful operations in medicine. Revision THA is most often indicated for instability, aseptic loosening, osteolysis, infection, periprosthetic fracture, component malposition, and catastrophic implant failure. Understanding the etiology of THA failure is essential for guiding clinical decision making[18]. The study design is a prospective, single-arm, multi-centre, observational, PMCF of the commercially available Monomod Stem Revision total hip replacement. This study is not previously reported, that’s why we evaluate the Monomod Stem Revision total hip replacement. By acquiring data on survivorship and revision rate, functional outcomes, patient-reported outcomes, and adverse events, and assessing the same, this study will provide valuable insights into the performance and safety of the Monomod stem revision total hip replacement in real-world clinical practice. The findings from this PMCF will complement existing evidence from controlled clinical trials and contribute to evidence-based decision-making regarding the use of this hip system. Thus, our study aims to improve patient care and outcomes regarding revisionTHR |