| CTRI Number |
CTRI/2025/05/087887 [Registered on: 29/05/2025] 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
|
Revision Stem (MonoMod) under Hip Replacement System |
|
Scientific Title of Study
|
A prospective, single-arm, multi-centre, observational, Post-Marketing Clinical Follow-up Study to evaluate the safety and performance of Revision stem (MonoMod) under hip replacement system in the real-world setting |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHCPL/Revision stem (MonoMod) V1.0.0 dated 12.11.25 |
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
|
| No of Sites = 1 |
| 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 |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Adroit 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
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Revision stem (MonoMod) under hip replacement is intended to be used in both men and women; adult and elderly patients.
2. Subject male or non-pregnant female age 18 years and older.
3. 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.
4. Subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations.
5. Subject should be non-pregnant women.
6. Subject has total hip arthroplasty and hemi-hip arthroplasty.
7. Subject has non-inflammatory degenerative joint diseases including osteoarthritis, post traumatic arthritis and a vascular necrosis.
8. Subject has rheumatoid arthritis, congenital hip dysplasia, acute traumatic fracture of the femoral head or neck, certain cases of ankylosis, dislocation of the hip, correction of functional deformity, revision of failed joint reconstruction or treatment, treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.
9. Subject is eligible for arthroplasty or hip replacement procedures.
10. Subject has arthroplasty that are unmanageable using other techniques.
11. Subject with acute traumatic fracture of the femoral head or neck that cannot be appropriately treated with internal fixation.
12. Subject fracture dislocation of the hip that cannot be appropriately treated with internal fixation.
13.Subject has avascular necrosis of the femoral head.
14. Subject has non-union of femoral neck fractures.
15. Subject with certain high subcapital and femoral neck fractures in the elderly.
16. Subject has degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement does not require replacement.
17. Subject has pathology involving only the femoral head/neck and proximal femur that can be adequately treated by hemi-hip arthroplasty. |
|
| ExclusionCriteria |
| Details |
1.Subject with a known sensitivity to device materials.
2. Subject is unwilling or unable to sign the Informed Consent Document.
3. Subject being considered for treatment by a doctor, would not comply with the follow-up schedule.
4. Pregnant women should be excluded.
5. Subject has a history of infection in the affected joint that may affect the function of the implanted prosthetic.
6. Subject has active local or systemic infection in the affected joint that may affect the function of the implanted prosthetic.
7. Subject with poor bone density or insufficient bone stock that is inadequate for support or fixation of the components.
8. Subject with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
9. Subject has any condition that may interfere with the survival of the implants such as Charcot’s disease, or Paget’s disease.
10. Subject with skeletally immature patients.
11. Any Subject with Pain-free and stable arthrodesis in an adequate functional position.
12. Subject has instable knee joint secondary to negative collateral ligament integrity.
13. Subject with hemi-hip arthroplasty, any pathological condition of the acetabulum, such as distorted acetabuli with irregularities, protrusion acetabuli (arthrokatadysis), or migrating acetabuli that would preclude the use of the natural acetabulum as an appropriate articular surface for the hemi-hip prosthesis.
14. Subject has conditions such as osteoporosis or poor bone stock, metabolic disorders or systemic pharmacological treatments leading to progressive, deterioration of solid bone support for the implant (e.g., Diabetes mellitus, steroid therapies, immunosuppressive therapies, etc.), history of general or local infections, severe deformities leading to impaired fixation or improper positioning of the implant, tumours of the supporting bone structures, allergic reactions to implant materials (e.g., bone cement, metal, polyethylene), congenital dysplasia of the hip which may reduce the bone stock available to support the acetabular cup component in total hip replacement, tissue reactions to implant corrosion or implant wear debris, and Disabilities of other joints (i.e., knees and ankles) tend to adversely affect the fixation of hip replacement implants. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Revision Rate |
1.Time frame: 1 month, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Range of Motion
2.Visual analog scale
3.Harris hip scores
4.Radiographic assessments
5.Infection assessment
6.Intraoperative Complication
7.Discrepancy Measurement
8.SF-12 Questionnaire
9.Adverse Events
10.Metallosis |
1.Time Frame: Pre-operative, 1 month, 6 months, 1 year, 3 years, 5 years, 7 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
|
Title: A prospective, single-arm, multi-centre, observational, Post-Marketing Clinical Follow-up Study to evaluate the safety and performance of Revision stem under hip replacement system in the real-world setting
Short Title: Revision stem under hip replacement system
Study population: The Revision stem under hip replacement 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 an evidence of sufficient sound bone to fix and support the components. Hemi-hip arthroplasty is performed in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to fix and support the femoral stem.
Objectives: The objective of this study is to assess the safety and performance of the Revision stem in patients who have undergone revision hip replacement surgery, within a real-world clinical setting.
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. The study design is a prospective, single-arm, multi-centre, observational, PMCF of the commercially available Revision Stem under hip replacement. This study is not previously reported, that’s why we evaluate the Revision Stem under 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 Revision stem under 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 revision THR. |