Efficacy of bone reduction device in femoral fracture reduction

Clinical trial study of short term results of closed intramedullary nailing with bone reduction device versus conventional open reduction method for closed midshaft femoral fractures

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230219057449N1

Enrollment

Registered

2023-09-05

Start date

2023-12-22

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

femoral shaft fracture. Fracture of shaft of femur

Interventions

Intervention 1: Intervention group: closed reduction with assistance of bone reduction device. in this method, the proximal and distal parts of fractured femur which fixed to 2 parallel cannulated sc

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: adult patient aged 20 fracture type OTA-A3 closed femur fracture one week interval between trauma to surgery consent form

Exclusion criteria

Exclusion criteria: pathologic fracture other fracture or trauma affecting rehabilitation program unconsciousness affecting rehabilitation program concomitant systemic disease affecting union such as diabetes or malignancy drug abuse, smoking or addictin

Design outcomes

Primary

Measure	Time frame
Union rate. Timepoint: months 1, 2, 3 and 6. Method of measurement: radiographic union that verified with three of four bridging callus in medial, lateral, anterior and posterior cortexes in radiographic images.	—

Secondary

Measure	Time frame
Surgery time. Timepoint: skin incision to final suture. Method of measurement: chromometer.;Fluoroscopy time. Timepoint: from start to ending of surgery. Method of measurement: chronometer.;Blood loss. Timepoint: the day after surgery. Method of measurement: hematocrit decrease.;Infection. Timepoint: each week in first month after surgery. Method of measurement: superficial or deep discharge or systemic symptoms.	—

Measure

Time frame

Surgery time. Timepoint: skin incision to final suture. Method of measurement: chromometer.;Fluoroscopy time. Timepoint: from start to ending of surgery. Method of measurement: chronometer.;Blood loss. Timepoint: the day after surgery. Method of measurement: hematocrit decrease.;Infection. Timepoint: each week in first month after surgery. Method of measurement: superficial or deep discharge or systemic symptoms.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Vahedi

Mashhad University of Medical Sciences

vahedie@mums.ac.ir+98 51 3608 4617

Outcome results

None listed

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