Skip to main content
OpenTrials
Completed

NCT Number: NCT05754320

TBW vs Plating in Olecranon Fractures

Background: While the tension band wiring (TBW) technique is commonly used for simple, displaced olecranon fractures, it is associated with complications such as hardware prominence. To date, studies comparing between the efficacy and safety of TBW and plate fixation for these fractures have not provided a conclusive answer.

Purposes: To investigate which of the two techniques provide better functional and radiological outcomes for simple displaced Mayo type 2A olecranon fractures, Which technique provides better patient-reported outcomes, What are the complication rates associated with each technique

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)

Be’er Ya‘aqov, 70300, Israel

About this study

Background: While the tension band wiring (TBW) technique is commonly used for simple, displaced olecranon fractures, it is associated with complications such as hardware prominence. To date, studies comparing between the efficacy and safety of TBW and plate fixation for these fractures have not provided a conclusive answer.

Purposes: To investigate which of the two techniques provide better functional and radiological outcomes for simple displaced Mayo type 2A olecranon fractures, Which technique provides better patient-reported outcomes, What are the complication rates associated with each technique Methods: A long-term, prospective, randomized study on 50 adult patients who underwent surgery to treat acute, simple, displaced olecranon fractures in a Hand and Upper Extremity Surgery Unit at a tertiary care center between November 2012 and October 2017. Patients were randomized on a 1:1 basis to either tension band or plate fixation and were evaluated at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery. Evaluation of long-term complications continued after 1 year as clinically indicated. The primary outcome measure was the 1-year postoperative Disabilities of the Arm, Shoulder and Hand (DASH) score. Additional outcome measures included patient-reported Oxford elbow score, functional (i.e., range of motion) and radiographic assessments and complication rates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • traumatic non-pathological simple olecranon fracture
  • age 18 years or older
  • presentation within 2 weeks of injury.

Exclusion criteria

  • inability to sign an informed consent
  • inability to comply with follow-up
  • associated elbow fractures
  • open fractures
  • pregnancy.

Treatment and study plan

Tension band wire fixation

Device

Tension band wire fixation

Plate fixation

Device

Tension band wire fixation

Primary outcomes

  1. Disabilities of the Arm, Shoulder and Hand score

    Time frame: 1 year

    1-year postoperative patient reported Disabilities of the Arm, Shoulder and Hand score. Scale - 0 (no disability) to 100 (most severe disability)

Secondary outcomes

  1. Oxford elbow score

    Time frame: 1 year

    1-year postoperative patient-reported Oxford elbow score. Scale - 0 (worst elbow functional score) to 48 (normal elbow functional score)

  2. Union rate

    Time frame: 1 year

    Union rate

  3. Complication rate

    Time frame: >1 year

    Long term complication rate

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

Tension Band Wire Fixation Versus Plating for Simple Displaced Olecranon Fractures: A Long-Term Prospective Randomized Trial

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2023
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.