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TBW vs Plating in Olecranon Fractures

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT05754320
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
59.7
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Tension band wire fixation
  • Device: Plate fixation
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Tension Band Wire Fixation Versus Plating for Simple Displaced Olecranon Fractures: A Long-Term Prospective Randomized Trial
Actual Study Start Date :
Nov 10, 2012
Actual Primary Completion Date :
Oct 28, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tension Band Wire fixation

patients suffering simple olecranon fracture, randomized for treatment of tension band wire fixation

Device: Tension band wire fixation
Tension band wire fixation
Experimental: Plate fixation

patients suffering simple olecranon fracture, randomized for treatment of plate fixation

Device: Plate fixation
Tension band wire fixation

Outcome Measures

Primary Outcome Measures

  1. Disabilities of the Arm, Shoulder and Hand score [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 Outcome Measures

  1. Oxford elbow score [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 [1 year]

    Union rate

  3. Complication rate [>1 year]

    Long term complication rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. traumatic non-pathological simple olecranon fracture

  2. age 18 years or older

  3. presentation within 2 weeks of injury.

Exclusion Criteria:

  1. inability to sign an informed consent

  2. inability to comply with follow-up

  3. associated elbow fractures

  4. open fractures

  5. pregnancy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center) Be'er Ya'aqov Israel 70300

Sponsors and Collaborators

  • Assaf-Harofeh Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonnatan Persitz, Principal Investigator, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT05754320
Other Study ID Numbers:
  • 94/13
First Posted:
Mar 3, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Fractures, Bone
Ulna Fractures

Study Results

No Results Posted as of Mar 3, 2023