MonoMod stem revision or complex primary total hip arthroplasty

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 - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/05/087887

Enrollment

197

Registered

2025-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M165- Unilateral post-traumatic osteoarthritis of hip

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.Revision RateTimepoint: 1.Time frame: 6 Week, 6 months, 1 year, 2 years, 5 years, 10 years	—

Secondary

Measure	Time frame
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 Timepoint: 1.Time Frame: Pre-operative, 6 Weeks, 6 months, 1 year, 2 years, 5 years, 10 years	—

Countries

India

Contacts

Public ContactDr Kirankumar Shetty

Meril Life Sciences Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026