The effect of anatomical locking plates in the treatment of tibia fractures

Investigating the anatomical locking plate as an external fixator on the quality of life and treatment results in patients with tibial fractures with soft tissue damage in comparison with common treatments in a clinical trial study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180422039382N5

Enrollment

Registered

2025-11-19

Start date

2026-01-18

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Shaft of Tibia Fracture. Fracture of shaft of tibia

Interventions

Intervention 1: Intervention group: If the wound is open, after initial preparation, the patients wound is thoroughly washed and debridement is performed. If possible, the patients wound is closed wit

Eligibility

Sex/Gender

All

Age

15 Years to 85 Years

Inclusion criteria

Inclusion criteria: Over 15 years of age and bone maturity Poor soft tissue condition to the extent that it cannot be suitable for Open Reduction & Internal Fixation (ORIF) Consent to participate in the study Fracture in the tibia and in the metaphyseal or metadiaphyseal part

Exclusion criteria

Exclusion criteria: Long-term use of corticosteroids Having severe vascular disease Uncontrolled diabetes Underlying diseases such as osteogenesis imperfecta and Ehlers-Danlos syndrome

Design outcomes

Primary

Measure	Time frame
Quality of life of patients. Timepoint: Before the start of the intervention and six months after the treatment. Method of measurement: SF 36 questionnaire.	—

Secondary

Measure	Time frame
Infection after surgery. Timepoint: Before the intervention, the first week, one month, two months and three months after the end of the intervention. Method of measurement: Based on the findings of the examination, including warmth, swelling, erythema, pus discharge, and radiography.;Degree of fusion. Timepoint: Before the intervention, the first week, one month, two months and three months after the end of the intervention. Method of measurement: Based on examination and radiography.;Range of motion. Timepoint: Before the intervention, immediately after surgery, twenty-one and and the forty- second weeks after surgery. Method of measurement: Through the examination with goniometer.;Need for repeat surgery. Timepoint: Before the intervention, the first week, one month, two months and three months after the end of the interventi. Method of measurement: Based on examination and radiography.	—

Measure

Time frame

Infection after surgery. Timepoint: Before the intervention, the first week, one month, two months and three months after the end of the intervention. Method of measurement: Based on the findings of the examination, including warmth, swelling, erythema, pus discharge, and radiography.;Degree of fusion. Timepoint: Before the intervention, the first week, one month, two months and three months after the end of the intervention. Method of measurement: Based on examination and radiography.;Range of motion. Timepoint: Before the intervention, immediately after surgery, twenty-one and and the forty- second weeks after surgery. Method of measurement: Through the examination with goniometer.;Need for repeat surgery. Timepoint: Before the intervention, the first week, one month, two months and three months after the end of the interventi. Method of measurement: Based on examination and radiography.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Pooria Farrokhkhani

Babol University of Medical Sciences

pooriafarrokhkhani@gmail.com+98 11 3225 6285

Outcome results

None listed

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