Management of Extra-Articular Distal-Third Humeral Fractures

Comparing Anterior Minimal Invasive Plate Osteosynthesis (MIPO) with PHILOS plate and Open Reduction Internal Fixation (ORIF) with T-Locking Posterior Plate for Extra-Articular Distal-Third Humeral Fractures: A Randomized Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211201053235N8

Enrollment

Registered

2025-10-10

Start date

2025-03-21

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Extra-Articular Distal-Third Humeral Fractures.

Interventions

Intervention 1: Intervention group: Patients undergoing surgery with minimally invasive plate osteosynthesis (MIPO) using a fibula plate in a supine position under general anesthesia, with two small i

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Acute distal humeral shaft fracture consent to participate in the study

Exclusion criteria

Exclusion criteria: Open fractures having severe underlying diseases that affect the incidence of complications or union, including RA and corticosteroid use,lupus, nerve or vascular damage before surgery previous surgical history of the injured limb multiple fractures or multiple trauma patients hospitalization in the intensive care unit lack of cooperation in follow-up or patient dissatisfaction age over 60 or under 20 heavy smoking

Design outcomes

Primary

Measure	Time frame
Bleeding. Timepoint: During surgery. Method of measurement: Through medical records and based on milliliters.;Range of motion. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Using the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire.;Surgical incision length. Timepoint: Post-surgery. Method of measurement: Measurement of incision length in centimeters through measurements taken during the operation.;Functional Outcomes. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Using the Motor Evaluation Protocol Questionnaire.;Union time. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Through radiographic imaging, considering welding, 3 cortices out of four cortices.;Complications. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Through examination and radiographic imaging, including cases of infection, intraoperative injuries, implant failure, and the need for reoperation.	—

Measure

Time frame

Bleeding. Timepoint: During surgery. Method of measurement: Through medical records and based on milliliters.;Range of motion. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Using the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire.;Surgical incision length. Timepoint: Post-surgery. Method of measurement: Measurement of incision length in centimeters through measurements taken during the operation.;Functional Outcomes. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Using the Motor Evaluation Protocol Questionnaire.;Union time. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Through radiographic imaging, considering welding, 3 cortices out of four cortices.;Complications. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Through examination and radiographic imaging, including cases of infection, intraoperative injuries, implant failure, and the need for reoperation.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMeisam Jafari Kafiabadi

Shahid Beheshti University of Medical Sciences

meisamjafarikafiabadi@gmail.com+98 21 2387 2206

Outcome results

None listed

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