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Device for reduction and fixation during surgery in long bone fractures

Designing and making Device for reduction and fixation during surgery in long bone fractures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241129063887N1
Enrollment
40
Registered
2024-12-04
Start date
2024-11-19
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Fractures of long bones (femur, tibia, humerus). Fracture of shaft of femur

Interventions

Intervention 1: Intervention group: A group of patients who use the new tool introduced in this research to help reduce and fix their bone fragments during surgery. This tool is made and includes two

Sponsors

Research Departement of AJA University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All people who have fractured long bones such as femur, tibia or humerus due to acute trauma People with the mentioned conditions who for any reason have indications for open surgery and plate fixation People who have fractures in other areas of the body in addition to long bone fractures People who have Peri-implant fractures in long bones People who have fractured long bones but have been allowed to undergo surgery with a delay due to brain injuries or general surgery.

Exclusion criteria

Exclusion criteria: People with pathological fractures People whose fractures have indications for fixation by methods other than open surgery with plates, such as nailing.

Design outcomes

Primary

MeasureTime frame
Time of surgery. Timepoint: Once the skin incision is made and the fractured bone fragments are exposed and the surgeon prepares for the reduction and bone fixation process, time will begin to count until the final bone fixation. Method of measurement: By the minutes.;The amount of bleeding during surgery. Timepoint: When the skin incision is made and the broken bone fragments are exposed and the surgeon prepares for the process of reduction and fixation of the bone, the amount of bleeding will begin to be calculated until the final fixation of the bone. Method of measurement: in milliliters.

Secondary

MeasureTime frame
The amount of pain after the operation. Timepoint: Pain 24 hours after the operation, which will be determined based on the visual pain scoring system or VAS (between 0 and 10 so that 0 is no pain and 10 is the most severe pain imaginable). Method of measurement: by number from one to ten.;Bone union after 2 months. Timepoint: The degree of union in post-op radiographs after 2 months of surgery. Method of measurement: yes or no.;Complications after surgery. Timepoint: Complications include wound problems or embolism 2 month surgery. Method of measurement: yes or no.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad Hemmatyar

Iran University of Medical Sciences

hematyar.a@iums.ac.ir+98 21 2233 9112

Outcome results

None listed

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