NCT03280602

Brief Summary

The incidence of olecranon fractures is 12 per 100.000. Traditionally, isolated olecranon fractures have been treated with tension band wiring (TBW). There is a trend towards increased use of plate fixation, though TBW has yielded good and comparable patient reported outcomes. The latter method is substantially cost-effective, but higher complication reports have been reported. There are only two randomized controlled trials comparing TBW and plate fixation, and the literature is inconclusive in which fixation method is preferable in the treatment of olecranon fractures. In this multi-center trial, adult patients (18-75 years) with isolated olecranon fractures will be randomized to either TBW or plate fixation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

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

First Submitted

Initial submission to the registry

September 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

4.8 years

First QC Date

September 9, 2017

Last Update Submit

November 10, 2024

Conditions

Olecranon Fracture

Outcome Measures

Primary Outcomes (1)

  • The Quick Disability of the Arm, Shoulder and Hand Outcome Measure (QuickDASH)

    The QuickDASH questionnaire evaluates difficulty performing specific tasks and symptoms, social and work function, sleep and confidence. Scaling is ranked from 0 indicating least disability to 100 indicating most disability.

    12 months

Secondary Outcomes (9)

  • Mayo Elbow Performance Score (MEPS)

    12 months

  • Grip strength

    12 months

  • Range of motion (ROM)

    12 months

  • The EuroQol five dimensions questionnaire (EQ-5D-5L)

    12 months

  • Satisfaction with elbow function

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Tension band wiring (TBW)

ACTIVE COMPARATOR

TBW following the AO principles with 2 x 1.6 mm K-wires and wire wire cerclage.

Procedure: Tension band wiring (TBW)Procedure: Plate fixation

Plate fixation

ACTIVE COMPARATOR

Plate fixation with Syntes VA-LCP olecranon plates 2.7/3.5

Procedure: Tension band wiring (TBW)Procedure: Plate fixation

Interventions

Tension band wiring (TBW)PROCEDURE

2 x K-wire fixation (1.6 mm) and wire cerclage.

Plate fixationTension band wiring (TBW)
Plate fixationPROCEDURE

Olecranon fractures in this arm are fixed with Synthes´ VA-LCP Olecranon Plates 2.7/3.5.

Plate fixationTension band wiring (TBW)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients younger than 18 or older than 75 years of age.
  • Unable to receive oral and written information.
  • Concomitant fracture in the injured extremity.
  • When the olecranon fracture extends distal to the coronoid process.
  • Previous injury or illness in the injured upper extremity with permanent reduced elbow function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, Norway

Location

Related Publications (15)

  • Duckworth AD, Clement ND, White TO, Court-Brown CM, McQueen MM. Plate Versus Tension-Band Wire Fixation for Olecranon Fractures: A Prospective Randomized Trial. J Bone Joint Surg Am. 2017 Aug 2;99(15):1261-1273. doi: 10.2106/JBJS.16.00773.

    PMID: 28763412BACKGROUND

  • 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

  • Buijze G, Kloen P. Clinical evaluation of locking compression plate fixation for comminuted olecranon fractures. J Bone Joint Surg Am. 2009 Oct;91(10):2416-20. doi: 10.2106/JBJS.H.01419.

    PMID: 19797577BACKGROUND

  • 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

  • Duckworth AD, Clement ND, Aitken SA, Court-Brown CM, McQueen MM. The epidemiology of fractures of the proximal ulna. Injury. 2012 Mar;43(3):343-6. doi: 10.1016/j.injury.2011.10.017. Epub 2011 Nov 9.

    PMID: 22077988BACKGROUND

  • Baecher N, Edwards S. Olecranon fractures. J Hand Surg Am. 2013 Mar;38(3):593-604. doi: 10.1016/j.jhsa.2012.12.036.

    PMID: 23428192BACKGROUND

  • Edwards SG, Martin BD, Fu RH, Gill JM, Nezhad MK, Orr JA, Ferrucci AM, Love JM, Booth R, Singer A, Hsieh AH. Comparison of olecranon plate fixation in osteoporotic bone: do current technologies and designs make a difference? J Orthop Trauma. 2011 May;25(5):306-11. doi: 10.1097/BOT.0b013e3181f22465.

    PMID: 21464739BACKGROUND

  • 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

  • Matar HE, Ali AA, Buckley S, Garlick NI, Atkinson HD. Surgical interventions for treating fractures of the olecranon in adults. Cochrane Database Syst Rev. 2014 Nov 26;2014(11):CD010144. doi: 10.1002/14651858.CD010144.pub2.

    PMID: 25426876BACKGROUND

  • 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

  • Snoddy MC, Lang MF, An TJ, Mitchell PM, Grantham WJ, Hooe BS, Kay HF, Bhatia R, Thakore RV, Evans JM, Obremskey WT, Sethi MK. Olecranon fractures: factors influencing re-operation. Int Orthop. 2014 Aug;38(8):1711-6. doi: 10.1007/s00264-014-2378-y. Epub 2014 Jun 4.

    PMID: 24893946BACKGROUND

  • Tarallo L, Mugnai R, Adani R, Capra F, Zambianchi F, Catani F. Simple and comminuted displaced olecranon fractures: a clinical comparison between tension band wiring and plate fixation techniques. Arch Orthop Trauma Surg. 2014 Aug;134(8):1107-14. doi: 10.1007/s00402-014-2021-9. Epub 2014 Jun 17.

    PMID: 24935660BACKGROUND

  • Wagner FC, Konstantinidis L, Hohloch N, Hohloch L, Suedkamp NP, Reising K. Biomechanical evaluation of two innovative locking implants for comminuted olecranon fractures under high-cycle loading conditions. Injury. 2015;46(6):985-9. doi: 10.1016/j.injury.2015.02.010. Epub 2015 Feb 18.

    PMID: 25771445BACKGROUND

  • Gruszka D, Arand C, Nowak T, Dietz SO, Wagner D, Rommens P. Olecranon tension plating or olecranon tension band wiring? A comparative biomechanical study. Int Orthop. 2015 May;39(5):955-60. doi: 10.1007/s00264-015-2703-0. Epub 2015 Feb 25.

    PMID: 25711396BACKGROUND

  • Wilson J, Bajwa A, Kamath V, Rangan A. Biomechanical comparison of interfragmentary compression in transverse fractures of the olecranon. J Bone Joint Surg Br. 2011 Feb;93(2):245-50. doi: 10.1302/0301-620X.93B2.24613.

    PMID: 21282766BACKGROUND

MeSH Terms

Conditions

Olecranon Fracture

Condition Hierarchy (Ancestors)

Elbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesUlna FracturesForearm InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Semi-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant orthopedic surgeon

Study Record Dates

First Submitted

September 9, 2017

First Posted

September 12, 2017

Study Start

December 1, 2017

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

November 12, 2024

Record last verified: 2024-11

Locations

NO(1)