Trial record 2 of 4 for:    Open Studies | "Ulna Fractures"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Royal Infirmary of Edinburgh
Sponsor:
Information provided by (Responsible Party):
Mr. AD Duckworth, Royal Infirmary of Edinburgh
ClinicalTrials.gov Identifier:
NCT01391936
First received: July 11, 2011
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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 Intervention
Displaced Olecranon Fractures
Procedure: Tension Band Wiring
Procedure: Plate fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Trial of Plate Fixation Versus Tension Band Wire for Olecranon Fractures

Resource links provided by NLM:


Further study details as provided by Royal Infirmary of Edinburgh:

Primary Outcome Measures:
  • DASH [ Time Frame: One year ] [ Designated as safety issue: No ]
    Patient rated outcome measure - DASH questionnaire at one year post injury/surgery.


Secondary Outcome Measures:
  • Mayo Elbow Performance Index (MEPI) [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.

  • Range of motion [ Time Frame: One year ] [ Designated as safety issue: No ]
    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

  • Pain [ Time Frame: One year ] [ Designated as safety issue: No ]
    Pain assessment on an analogue scale 1-10.

  • Radiographic Assessment [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.

  • Time taken to return to activities [ Time Frame: One year ] [ Designated as safety issue: No ]
    Time taken to return to activities of daily living/work/sport


Estimated Enrollment: 70
Study Start Date: September 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391936

Contacts
Contact: Andrew D Duckworth, MSc, MRCSEd 07769701875 andrew.duckworth@yahoo.co.uk
Contact: Margaret M McQueen, MD, FRCSEd 0131 242 3427 mmcqueen@staffmail.ed.ac.uk

Locations
United Kingdom
Edinburgh Orthopaedic Trauma Unit Recruiting
Edinburgh, Lothian, United Kingdom, EH16 4SU
Contact: Andrew D Duckworth, MSc, MCRSEd    07769701875    andrew.duckworth@yahoo.co.uk   
Sub-Investigator: Andrew D Duckworth, MSc, MRCSEd         
Principal Investigator: Margaret M McQueen, MD, FRCSEd         
Sponsors and Collaborators
Mr. AD Duckworth
Investigators
Principal Investigator: Margaret M McQueen, MD, FRCSEd Edinburgh Orthopaedic Trauma Unit
  More Information

Publications:

Responsible Party: Mr. AD Duckworth, StR, Royal Infirmary of Edinburgh
ClinicalTrials.gov Identifier: NCT01391936     History of Changes
Other Study ID Numbers: 2010/RlOST/04
Study First Received: July 11, 2011
Last Updated: May 20, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Fractures, Bone
Ulna Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on July 26, 2014