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A Trial of Plate Fixation Versus Tension Band Wire for Olecranon Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01391936
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : October 6, 2016
Information provided by (Responsible Party):
Andrew D Duckworth, Royal Infirmary of Edinburgh

Brief Summary:
Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence regarding the optimal treatment and outcome of these fractures with only one prospective randomized trial (1992) in the literature comparing tension band wire and plate fixation for displaced olecranon fracture. Our trial includes all patients under the age of 75yrs presenting to the Edinburgh Orthopaedic Trauma Unit with an isolated olecranon fracture requiring operative intervention. Patients who consent to enrol in the trial will be randomised to operative fixation using one of two recognised fixation techniques - tension band wire fixation or plate fixation. Patients will be evaluated over a one year period following their surgery.

Condition or disease Intervention/treatment Phase
Displaced Olecranon Fractures Procedure: Tension Band Wiring Procedure: Plate fixation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Trial of Plate Fixation Versus Tension Band Wire for Olecranon Fractures
Study Start Date : September 2010
Actual Primary Completion Date : October 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Tension Band Wiring
Patients in this arm will receive the tension band wiring technique for fixation of their olecranon fracture.
Procedure: Tension Band Wiring
AO technique of TBW for fixation of fracture.

Plate fixation
Patients in this arm will receive plate and screw fixation of their olecranon fracture.
Procedure: Plate fixation
Patients in this arm will receive plate and screw fixation of their olecranon fracture.

Primary Outcome Measures :
  1. DASH [ Time Frame: One year ]
    Patient rated outcome measure - DASH questionnaire at one year post injury/surgery.

Secondary Outcome Measures :
  1. Mayo Elbow Performance Index (MEPI) [ Time Frame: One year ]
    Completion of the Mayo Elbow Performance Index (MEPI), a physician rate scale of function will completed for all patients15. The MEPI is a validated hundred-point system based upon pain (forty five points), range of motion (twenty points), stability (ten points) and daily function (twenty five points). Categorical ratings are assigned as follows: ninety to one hundred points is rated excellent; seventy-five to eighty-nine, good; sixty to seventy-four, fair; and less than sixty points, poor.

  2. Range of motion [ Time Frame: One year ]
    Range of motion at the elbow and forearm: will be measured using a standard full circle goniometer. Flexion, extension, supination and prontation will be measured in triplicate and the mean recorded to minimise intra-observer bias

  3. Pain [ Time Frame: One year ]
    Pain assessment on an analogue scale 1-10.

  4. Radiographic Assessment [ Time Frame: Six months ]
    Radiographic assessment used standard anteroposterior (AP) and lateral radiographs of the elbow. Outcome will also be assessed in detail with regards to loss of fracture reduction, complications, union and the development of radiographic degenerative changes.

  5. Time taken to return to activities [ Time Frame: One year ]
    Time taken to return to activities of daily living/work/sport

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 74 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥16 years to <75yrs
  2. Minimal/moderate fragmentation of the olecranon
  3. Within two weeks of olecranon fracture

Exclusion Criteria:

  1. Pregnant women with pre-determined treatment
  2. Patients unable to give informed consent
  3. Associated fractures to the coronoid, radial head and/or distal humerus
  4. Associated ligamentous injury, dislocation or subluxation
  5. Open fractures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01391936

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United Kingdom
Edinburgh Orthopaedic Trauma Unit
Edinburgh, Lothian, United Kingdom, EH16 4SU
Sponsors and Collaborators
Andrew D Duckworth
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Principal Investigator: Margaret M McQueen, MD, FRCSEd Edinburgh Orthopaedic Trauma Unit

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Responsible Party: Andrew D Duckworth, StR, Royal Infirmary of Edinburgh Identifier: NCT01391936    
Other Study ID Numbers: 2010/RlOST/04
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Peer reviewed publication - under review
Additional relevant MeSH terms:
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Fractures, Bone
Ulna Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries