Revision Stem (MonoMod) under Hip Replacement System

Not Applicable

Not yet recruiting

Conditions: Unilateral post-traumatic osteoarthritis of hip,

Registration Number: CTRI/2025/05/087887

Lead Sponsor: Meril Life Sciences Pvt Ltd

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 197

Inclusion Criteria

1.Revision stem (MonoMod) under hip replacement is intended to be used in both men and women; adult and elderly patients.
Subject male or non-pregnant female age 18 years and older.
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.
Subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations.
Subject should be non-pregnant women.
Subject has total hip arthroplasty and hemi-hip arthroplasty.
Subject has non-inflammatory degenerative joint diseases including osteoarthritis, post traumatic arthritis and a vascular necrosis.
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.
Subject is eligible for arthroplasty or hip replacement procedures.
Subject has arthroplasty that are unmanageable using other techniques.
Subject with acute traumatic fracture of the femoral head or neck that cannot be appropriately treated with internal fixation.
Subject fracture dislocation of the hip that cannot be appropriately treated with internal fixation.
13.Subject has avascular necrosis of the femoral head.
Subject has non-union of femoral neck fractures.
Subject with certain high subcapital and femoral neck fractures in the elderly.
Subject has degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement does not require replacement.
Subject has pathology involving only the femoral head/neck and proximal femur that can be adequately treated by hemi-hip arthroplasty.

Exclusion Criteria

1.Subject with a known sensitivity to device materials.
Subject is unwilling or unable to sign the Informed Consent Document.
Subject being considered for treatment by a doctor, would not comply with the follow-up schedule.
Pregnant women should be excluded.
Subject has a history of infection in the affected joint that may affect the function of the implanted prosthetic.
Subject has active local or systemic infection in the affected joint that may affect the function of the implanted prosthetic.
Subject with poor bone density or insufficient bone stock that is inadequate for support or fixation of the components.
Subject with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
Subject has any condition that may interfere with the survival of the implants such as Charcot’s disease, or Paget’s disease.
Subject with skeletally immature patients.
Any Subject with Pain-free and stable arthrodesis in an adequate functional position.
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.
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.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Revision Rate	1.Time frame: 1 month, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years

Secondary Outcome Measures

Name	Time	Method
1.Range of Motion	2.Visual analog scale

Trial Locations

Locations (1): Aditi Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Aditi Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Shailendra Patil
Principal investigator
9320620978
shailendra_patil@yahoo.com