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Comparison of conventional reaming technique with reamer irrigator aspirator (ria) for changes on the heart during fixation of shaft femur fracture

Comparison of conventional reaming technique with reamer irrigator aspirator (ria) for hemodynamic, cardiac changes and embolic load during fixation of shaft femur fracture using an intramedullary nail and estimation of osteogenic growth factors in ria graft aspirate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049190
Enrollment
30
Registered
2023-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: S723- Fracture of shaft of femur Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Reamer-irrigator-aspirator
RIA technique: Patients will undergo fixation of the femur fracture using an intramedullary nail with the use of the reamer-irrigator-aspirator (RIA) system. This is a single time point study during p

Sponsors

All India Institute of Medical Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18-60 years 2. Diagnosis of isolated fractures amenable to nailing femur fracture requiring surgery and suitable for fixation with an antegrade IM nail 3. Patients giving informed, written consent to be a partof the study

Exclusion criteria

Exclusion criteria: 1. Non-fractures amenable to nailing femur fracture 2. Open fracture 3. A pathological fracture 4. Patients having any of these comorbid conditions: 5. Intracranial events (stroke, bleeding, infection), Fluid or electrolyte disturbances (including dehydration, hyponatremia, Hypernatremia), Acute cardiac events: myocardial infarction, congestive heart failure exacerbation, arrhythmia, Acute pulmonary events: asthma or chronic obstructive pulmonary disease exacerbation, pulmonary embolism, hypoxemia, hypercarbia, on anti-coagulants or antiplatelet drugs. 6. Patients not giving consent

Design outcomes

Primary

MeasureTime frame
To assess the intraoperative hemodynamic and cardiac effects in intramedullary femur nailing for fracture shaft of femur using conventional reaming technique and comparing with reamer irrigator aspirator (RIA).Timepoint: 0-30 months: Patient recruitment and performance of surgical procedure (intramedullary nailing) on the included patients 0-30 months: Simultaneous collection of intraoperative samples and processing in laboratory 30-36 months: Analysis of data, preparation of project report—

Secondary

MeasureTime frame
To estimate and compare the release of osteogenic growth factors in the graft aspirate obtained using the conventional reaming technique and the reamer irrigator aspirator (RIA) techniqueTimepoint: 0-30 months: Patient recruitment and performance of surgical procedure (intramedullary nailing) on the included patients 0-30 months: Simultaneous collection of intraoperative samples and processing in laboratory 30-36 months: Analysis of data, preparation of project report—

Countries

India

Contacts

Public ContactSamarth Mittal

All India Institute of Medical Sciences, New Delhi

samarthmittal@gmail.com9013562489

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026