NCT01391936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

5.1 years

First QC Date

July 11, 2011

Last Update Submit

October 5, 2016

Conditions

Displaced Olecranon Fractures

Outcome Measures

Primary Outcomes (1)

  • DASH

    Patient rated outcome measure - DASH questionnaire at one year post injury/surgery.

    One year

Secondary Outcomes (5)

  • Mayo Elbow Performance Index (MEPI)

    One year

  • Range of motion

    One year

  • Pain

    One year

  • Radiographic Assessment

    Six months

  • Time taken to return to activities

    One year

Study Arms (2)

Tension Band Wiring

OTHER

Patients in this arm will receive the tension band wiring technique for fixation of their olecranon fracture.

Procedure: Tension Band Wiring

Plate fixation

OTHER

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

Procedure: Plate fixation

Interventions

Tension Band WiringPROCEDURE

AO technique of TBW for fixation of fracture.

Tension Band Wiring
Plate fixationPROCEDURE

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

Plate fixation

Eligibility Criteria

Age16 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥16 years to \<75yrs
  • Minimal/moderate fragmentation of the olecranon
  • Within two weeks of olecranon fracture

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edinburgh Orthopaedic Trauma Unit

Edinburgh, Lothian, EH16 4SU, United Kingdom

Location

Related Publications (13)

  • Newman SD, Mauffrey C, Krikler S. Olecranon fractures. Injury. 2009 Jun;40(6):575-81. doi: 10.1016/j.injury.2008.12.013. Epub 2009 Apr 23.

    PMID: 19394931BACKGROUND

  • Veras Del Monte L, Sirera Vercher M, Busquets Net R, Castellanos Robles J, Carrera Calderer L, Mir Bullo X. Conservative treatment of displaced fractures of the olecranon in the elderly. Injury. 1999 Mar;30(2):105-10. doi: 10.1016/s0020-1383(98)00223-x.

    PMID: 10476278BACKGROUND

  • Rommens PM, Kuchle R, Schneider RU, Reuter M. Olecranon fractures in adults: factors influencing outcome. Injury. 2004 Nov;35(11):1149-57. doi: 10.1016/j.injury.2003.12.002.

    PMID: 15488508BACKGROUND

  • Fyfe IS, Mossad MM, Holdsworth BJ. Methods of fixation of olecranon fractures. An experimental mechanical study. J Bone Joint Surg Br. 1985 May;67(3):367-72. doi: 10.1302/0301-620X.67B3.3997942.

    PMID: 3997942BACKGROUND

  • Karlsson MK, Hasserius R, Karlsson C, Besjakov J, Josefsson PO. Fractures of the olecranon: a 15- to 25-year followup of 73 patients. Clin Orthop Relat Res. 2002 Oct;(403):205-12.

    PMID: 12360028BACKGROUND

  • Chalidis BE, Sachinis NC, Samoladas EP, Dimitriou CG, Pournaras JD. Is tension band wiring technique the "gold standard" for the treatment of olecranon fractures? A long term functional outcome study. J Orthop Surg Res. 2008 Feb 22;3:9. doi: 10.1186/1749-799X-3-9.

    PMID: 18294381BACKGROUND

  • Murphy DF, Greene WB, Gilbert JA, Dameron TB Jr. Displaced olecranon fractures in adults. Biomechanical analysis of fixation methods. Clin Orthop Relat Res. 1987 Nov;(224):210-4.

    PMID: 3665242BACKGROUND

  • Murphy DF, Greene WB, Dameron TB Jr. Displaced olecranon fractures in adults. Clinical evaluation. Clin Orthop Relat Res. 1987 Nov;(224):215-23.

    PMID: 3665243BACKGROUND

  • Gartsman GM, Sculco TP, Otis JC. Operative treatment of olecranon fractures. Excision or open reduction with internal fixation. J Bone Joint Surg Am. 1981 Jun;63(5):718-21.

    PMID: 7240294BACKGROUND

  • Macko D, Szabo RM. Complications of tension-band wiring of olecranon fractures. J Bone Joint Surg Am. 1985 Dec;67(9):1396-401.

    PMID: 3908460BACKGROUND

  • Hume MC, Wiss DA. Olecranon fractures. A clinical and radiographic comparison of tension band wiring and plate fixation. Clin Orthop Relat Res. 1992 Dec;(285):229-35.

    PMID: 1446443BACKGROUND

  • Bailey CS, MacDermid J, Patterson SD, King GJ. Outcome of plate fixation of olecranon fractures. J Orthop Trauma. 2001 Nov;15(8):542-8. doi: 10.1097/00005131-200111000-00002.

    PMID: 11733669BACKGROUND

  • Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.

    PMID: 8773720BACKGROUND

Study Officials

  • Margaret M McQueen, MD, FRCSEd

    Edinburgh Orthopaedic Trauma Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
StR

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 12, 2011

Study Start

September 1, 2010

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

October 6, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Peer reviewed publication - under review

Locations

GB(1)