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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 288
- Locations
- 10
- Primary Endpoint
- Rate of re-operation
Study Overview
Brief Summary
Study Title: Intramedullary Nails PMCF Study: A retrospective, multi-center, observational, real-world postmarket 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
Study Design: A retrospective, multi-center, observational, real-world postMarket clinical follow-up study.
Objective: To evaluate the safety and 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.
Follow-ups: As this is a retrospective study, the patient’s records will be reviewed for only observations and the data will be collected over 2 years.
Indication: Intramedullary Nails indicated 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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients who have been treated with Intramedullary Nails and have completed a minimum of 02 year follow up.
Exclusion Criteria
- •Asthis is a retrospective review of data, there are no formal exclusion criteria for the study.
Outcomes
Primary Outcomes
Rate of re-operation
Time Frame: Time Frame: Through 1 year
Secondary Outcomes
- 1.Mean Operation Time in minutes(2.Post-operative hospital stay)
Investigators
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd