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Intramedullary Nails

A retrospective, multi-center, observational, real-world post-market clinical follow-up study to evaluate the safety & performance of Intramedullary nails used in the fixation of long bone fractures,including diaphyseal fractures in the humerus, tibia, femur, and shaft fractures 5 cm below the surgical neck, and 5 cm proximal to the distal end of the medullary canal. - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065554
Enrollment
288
Registered
2024-04-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: M979- Periprosthetic fracture around unspecified internal prosthetic joint

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Meril Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who have been treated with Intramedullary Nails and have completed a minimum of 02 year follow up

Exclusion criteria

Exclusion criteria: Asthis is a retrospective review of data, there are no formal exclusion criteria for the study

Design outcomes

Primary

MeasureTime frame
Rate of re-operation Timepoint: Time Frame: Through 1 year

Secondary

MeasureTime frame
1.Mean Operation Time in minutes 2.Post-operative hospital stay 3.Any Device Malfunction or Device Failure 4.Post-operative mobility 5.Adverse eventTimepoint: 1.Time Frame: Intraoperative 2.Time Frame: After operation 3.Intra and Post-operative through 2 - year 4.Time Frame: 2-year 5.Time Frame: 2-year

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 4, 2026